1994L0025 — EN — 30.06.1994 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE94/25/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of16June1994
ontheapproximationofthelaws,regulationsandadministrativeprovisionsoftheMemberStates
relating torecreational craft
(OJ L 164, 30.6.1994, p. 15)
Corrected by:
►C1Corrigendum, OJ L 127, 10.6.1995, p. 27 (94/25/EC)
►C2Corrigendum, OJ L 41, 15.2.2000, p. 20 (94/25/EC)
▼B
DIRECTIVE 94/25/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of16June1994
on the approximation of the laws, regulations and administrative
provisionsoftheMemberStatesrelating torecreational craft
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance with the procedure laid down in Article 189b of
the Treaty (3),
Whereasthe internal market isto compris e an area without internal
frontiers in which the free movement of goods, persons, services andcapital isens ured;
Whereas the laws, regulations and administrative provisions in force in
the various Member States relating to the safety characteristics ofrecreational craft differ in scope and content; whereas such disparitiesare liable to create barriersto trade and unequal conditionsof competi-
tion within the internal market;
Whereasharmonization of national legis lation isthe only way in which
to remove these barriers to free trade; whereas this objective cannot besatisfactorily achieved by the individual Member States; whereas thisDirective merely laysdown the requirementsvital to freedom of move-ment for recreational craft;
WhereasthisDirective s hould cover only recreational craft of a
minimum length of 2,5 m and a maximum length of 24 m, derived
from the ISO standards;
Whereasthe removal of technical barriersin the field of recreational
craft and their components, to the extent that they cannot be removedby mutual recognition of equivalence among all the Member States,should follow the new approach set out in the Council resolution of 7
May 1985 (
4) which calls for the definition of essential requirements on
safety and other aspects which are important for the general well-being;whereas paragraph 3 of Article 100a provides that, in its proposals,concerning health, safety, environmental protection and consumerprotection, the Commission will take as a base a high level of protec-tion; whereas the essential requirements constitute the criteria with
which recreational craft, partly completed craft and their components
when separate and when installed must comply;
Whereas, therefore, this Directive sets out essential requirements only;
whereas, in order to facilitate the task of proving compliance with theessential requirements, harmonized European standards are necessaryfor recreational craft and their componentsasreferred to in Annex II;
whereasharmonized European s tandardsare drawn up by private
bodies and must retain their non-mandatory status; whereas, for thispurpose, the European Committee for Standardization (CEN) and theEuropean Committee for Electrotechnical Standardization (Cenelec)are recognized asthe bodiescompetent to adopt harmonized s tandardswhich follow the general guidelinesfor cooperation between the1994L0025 — EN — 30.06.1994 — 000.001 — 2
(1) OJ No C 123, 15. 5. 1992, p. 7.
(2) OJ No C 313, 30. 11. 1992, p. 38.
(3) Opinion of the European Parliament of 16 November 1992 (OJ No C 337,
21. 12. 1992, p. 17); Council common position of 16 December 1993 (OJ
No C 137, 19. 5. 1994, p. 1); Decision of the European Parliament of 9
March 1994 (OJ No C 91, 28. 3. 1994).
(4) OJ No C 136, 4. 6. 1985, p. 1.
▼B
Commission and those two bodies, signed on 13 November 1984;
whereas, for the purposes of this Directive, a harmonized standard is atechnical specification (European Standard or harmonization document)
adopted by one or other of those bodies, or by both, at the prompting
of the Commission pursuant to Council Directive 83/189/EEC of 28March 1983 laying down a procedure for the provision of informationin the field of technical standards and regulations (
1) and pursuant to
the general guidelinesreferred to above;
Whereas, in view of the nature of the risks involved in the use of
recreational craft and their components, it is necessary to establishprocedures applying to the assessment of compliance with the essentialrequirements of the Directive; whereas these procedures must bedevised in the light of the level of risk which may be inherent in
recreational craft and their components; whereas, therefore, each cate-
gory of conformity must be supplemented by an appropriate procedureor a choice between several equivalent procedures; whereas the proce-duresadopted comply with Council Decis ion 93/465/EEC of 22 July1993 concerning the modulesfor the variousphas esof the conformity
assessment procedures and the rules for the affixing and use of the CE
conformity marking which are intended to be used in the technicalharmonization Directives(
2);
Whereasthe Council hasprovided for the affixing of the CE marking
by either the manufacturer or hisauthorized repres entative within the
Community; whereasthat mark meansthat the recreational craft and
components comply with all the essential requirements and assessmentproceduresprovided for by the Community law applying to theproduct;
Whereasit isappropriate that the Member States , asprovided for by
Article 100a (5) of the Treaty, may take provisional measures to limit
or prohibit the placing on the market and the use of recreational craftor constituent products thereof in cases where they present a particularrisk to the safety of persons and, where appropriate, domestic animalsor property, provided that the measures are subject to a Community
control procedure;
Whereasthe recipientsof any decis ion taken aspart of thisDirective
must be aware of the reasons behind that decision and the means ofappeal open to them;
Whereas it is necessary to provide for a transitional arrangement
enabling recreational craft and their componentsmanufactured incompliance with the national regulationsin force at the date of adop-tion of thisDirective to be marketed and placed in s ervice;
WhereasthisDirective doesnot contain any provis ionsdirected
towardslimiting the us e of the recreational craft after it hasbeen put
into service;
Whereasthe cons truction of recreational craft may have an impact on
the environment to the extent that the craft may discharge polluting
substances; whereas it is therefore necessary to include provisions on
the protection of the environment in the Directive, in so far as thoseprovisions concern the construction of recreational craft from the pointof view of itsdirect impact on the environment;
Whereas the provisions of this Directive should not affect Member
States' entitlement to lay down, in accordance with the Treaty, such
requirements as they may deem necessary concerning navigation oncertain watersfor the purpos e of protection of the environment, thefabric of waterways and ensuring safety on waterways, provided thatthisdoesnot mean that the recreational craft ismodified in a way notspecified in this Directive,1994L0025 — EN — 30.06.1994 — 000.001 — 3
(1) OJ No L 109, 26. 4. 1983, p. 8. Directive aslas t amended by Directive 88/
182/EEC (OJ No L 81, 26. 3. 1988, p. 75).
(2) OJ No L 220, 30. 8. 1993, p. 23.
▼B
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
Article 1
1. ThisDirective s hall apply to recreational craft, partly completed
boatsand componentsreferred to in Annex II when s eparate andwhen installed.
2. ‘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 harmonized standards intended for sports
and leisure purposes. The fact that the same boat could be used forcharter or for recreational boating training shall not prevent it beingcovered by thisDirective when it isplaced on the market for recrea-tional purposes.
3. The following shall be excluded from the scope of this Directive:
(a) craft intended solely for racing, including rowing racing boats and
training rowing boatslabelled ass uch 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 materialsand labelled
ass uch by the manufacturer;
(f) experimental craft, provided that they are not subsequently placed
on the Community market;
(g) craft built for own use, provided that they are not subsequently
placed on the Community market during a period of five years;
(h) craft specifically intended to be crewed and to carry passengers for
commercial purposes, without prejudice to paragraph 2, in parti-cular those defined in ►
C2Council Directive 82/714/EEC of 4
October 1982 ◄laying down technical requirementsfor inland
waterway vessels (1), regardless of the number of passengers;
(i) submersibles;
(j) air cushion vehicles;
(k) hydrofoils.
Article 2
Placingonthemarketandputtingintoservice
1. Member States shall take all necessary measures to ensure that
the productsreferred to in Article 1 (1) may be placed on the marketand put into service for use in accordance with their intended purposeonly if they do not endanger the safety and health of persons, propertyor the environment when correctly constructed and maintained.
2. The provisions of this Directive shall not prevent Member States
from adopting, in compliance with the Treaty, provisions concerningnavigation on certain watersfor the purpos e of protection of the envir-onment, the fabric of waterways, and ensuring safety of waterways,providing that thisdoesnot require modification to craft conformingto thisDirective.1994L0025 — EN — 30.06.1994 — 000.001 — 4
(1) OJ No L 301, 28. 10. 1982, p. 1.
▼B
Article 3
Essentialrequirements
The products referred to in Article 1 (1) shall meet the essential safety,
health, environmental protection and consumer protection requirementsset out in Annex I.
Article 4
Free movementoftheproductsreferred toinArticle 1(1)
1. Member States shall not prohibit, restrict or impede the placing
on the market and putting into service in their territory of the productsreferred to in Article 1 (1) bearing the CE marking referred to inAnnex IV, which indicatestheir conformity with all provis ionsof thisDirective, including the conformity proceduress et out in Chapter II.
2. Member States shall not prohibit, restrict or impede the placing
on the market of partly-completed boatswhere the builder or hisauthorized representative established in the Community or the personresponsible for the placing on the market declares, in accordance withAnnex IIIA, that they are intended to be completed by others.
3. Member States shall not prohibit, restrict or impede the placing
on the market and putting into service of components referred to inAnnex II and bearing the CE marking referred to in Annex IV whichindicates their conformity with the relevant essential requirementswhere these components are intended to be incorporated into recrea-
tional craft, in accordance with the declaration, referred to in Annex
IIIB, of the manufacturer, his authorized representative established inthe Community or, in the case of imports from a third country, of anyperson who places those components on the Community market.
4. At trade fairs, exhibitions, demonstrations, etc., Member States
shall not create any obstacles to the showing of the products referred
to in Article 1 (1) which do not comply with thisDirective, providedthat a visible sign clearly indicates that such products may not bemarketed or put into service until they have been made to comply.
5. Where the productsreferred to in Article 1 (1) are s ubject to other
Directives concerning other aspects and which also provide for the
affixing of the CE marking, the latter shall indicate that such productsalso fulfil the provisions of those other Directives. However, shouldone or more of those Directives allow the manufacturer, during a tran-sitional period, to choose which arrangements to apply, the CE markingshall indicate that the product fulfils the provisions only of those Direc-
tives applied by the manufacturer. In this case, the particulars of those
Directives, as published in the Official Journal of the European
Communities , must be given in the documents, notices or instructions
required by those Directives and accompanying such products.
Article 5
Member States shall presume compliance with the essential require-
mentsreferred to in Article 3 of productsreferred to in Article 1 (1)which meet the relevant national standards adopted pursuant to theharmonized standards the references of which have been published intheOfficial Journal of the European Communities ; Member Statess hall
publish the references of such national standards.
Article 6
1. Where a Member State or the Commission is of the opinion that
the harmonized standards referred to in Article 5 do not fully meet theessential requirements referred to in Article 3, the Commission or theMember State shall notify the committee set up under Directive 83/
189/CEE, setting out its reasons. The committee shall deliver an urgent
opinion.
In the light of the opinion of the committee, the Commission shall
inform Member States if the standards concerned should be withdrawnfrom the publicationsreferred to in Article 5.1994L0025 — EN — 30.06.1994 — 000.001 — 5
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2. The Commission may adopt any appropriate measure with a view
to ensuring that this Directive is applied practically in a uniformmanner in pursuance of paragraph 3.
3. The Commission shall be assisted by a Standing Committee
composed of representatives appointed by the Member States andchaired by a representative from the Commission.
The Standing Committee shall draw up its own rules of procedure.
The representative of the Commission shall submit to the Committee a
draft of the measures to be taken. The Committee shall deliver itsopinion on the draft within a time limit which the chairman may laydown according to the urgency of the matter, if necessary by taking avote.
The opinion shall be recorded in the minutes; in addition, each Member
State shall have the right to ask to have its position recorded in theminutes.
The Commission shall take the utmost account of the opinion delivered
by the Committee. It shall inform the Committee of the manner in
which itsopinion hasbeen taken into account.
4. The Standing Committee may, in addition, examine any question
concerning the application of thisDirective and rais ed by itschairman,either at the chairman'sinitiative or at the reques t of a Member State.
Article 7
Safeguardclause
1. Where a Member State ascertains that recreational craft or
componentsreferred to in Annex II and bearing the CE markingreferred to in Annex IV when correctly constructed, installed, main-tained and used in accordance with their intended purpose may
endanger the safety and health of persons, property or the environment,
it shall take all appropriate interim measures to withdraw them fromthe market or prohibit or restrict their being placed on the market orput into service.
The Member State shall immediately inform the Commission of any
such measure, indicating the reasons for its decision, in particular
where non-conformity isthe res ult of:
(a) failure to comply with the essential requirements referred to in
Article 3;
(b) incorrect application of the standards referred to in Article 5, in so
far as it is claimed that those standards have been applied;
(c) shortcomings in the standards referred to in Article 5 themselves.
2. The Commission shall enter into consultation with the parties
concerned as soon as possible. Where, after such consultation, theCommission finds that:
— the measures are justified, it shall immediately so inform the
Member State which took the initiative and the other MemberStates; where the decision referred to in paragraph 1 is attributedto shortcomings in the standards, the Commission shall, after
consulting the parties concerned, bring the matter before the
Committee referred to in Article 6 (1) within two months, if theMember State which hastaken the decis ion intendsto maintain it,and shall initiate the procedure referred to in Article 6 (1),
— the measures are unjustified, it shall immediately so inform the
Member State which took the initiative and the manufacturer orhis authorized representative established in the Community.
3. Where a non-complying component referred to in Annex II or
craft bears the CE marking, the appropriate measures shall be takenby the Member State which hasauthority over whoms oever affixedthe marking; that Member State shall inform the Commission and theother Member Statesthereof.1994L0025 — EN — 30.06.1994 — 000.001 — 6
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4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
CHAPTER II
Conformityassessment
Article 8
Before producing and placing on the market productsreferred to in
Article 1 (1), the manufacturer or his authorized representative estab-
lished in the Community shall apply the following procedures for boatdesign categories A, B, C and D as referred to in Section 1 of Annex I.
1.For categories A and B:
— for boatsof les sthan 12 m hull length: the internal production
control plustes ts(module Aa) referred to in Annex VI,
— for boatsfrom 12 m to 24 m hull length: the EC type-examina-
tion (module B) referred to in Annex VII supplemented bymodule C (type conformity) referred to in Annex VIII, or anyof the following modules: B + D, or B + F, or G or H.
2.For category C:
(a) for boatsfrom 2,5 m to 12 m hull length:
— where the harmonized standards relating to sections 3.2 and
3.3 of Annex I are complied with: the internal production
control (module A), referred to in Annex V,
— where the harmonized standards relating Sections 3.2 and 3.3
of Annex I are not complied with: the internal production
control plustes ts(module Aa) referred to in Annex VI.
(b) for boatsfrom 12 m to 24 m hull length: the EC type-examina-
tion (module B) referred to in Annex VII followed by module C(type conformity) referred to in Annex VIII, or any of thefollowing modules: B + D, or B + F, or G or H.
3.For category D:
For boatsfrom 2,5 m to 24 m hull length: the internal production
control (module A) referred to in Annex V.
4. For componentsreferred to in Annex II: any of the following
modules: B + C, or B + D, or B + F, or G or H.
Article 9
Notifiedbodies
1. Member States shall notify the Commission and other Member
Statesof the bodieswhich they have appointed to carry out the tas kspertaining to the conformity assessment procedures referred to inArticle 8, together with the specific tasks which these bodies havebeen appointed to carry out and the identification numbers assigned tothem beforehand by the Commission.
The Commission shall publish a list of the notified bodies, together
with the identification numbersit hasallocated to them and the tas ks
for which they have been notified, in the Official Journal of the
European Communities . It shall ensure that the list is kept up to date.
2. Member Statess hall apply the criteria laid down in Annex XIV in
assessing the bodies to be indicated in such notification. Bodiesmeeting the assessment criteria laid down in the relevant harmonizedstandards shall be presumed to fulfil those criteria.
3. A Member State shall withdraw its approval from such a body if
it is established that the latter no longer satisfies the criteria referred toin Annex XIV. It shall inform the Commission and the other MemberStatesof itsaction forthwith.1994L0025 — EN — 30.06.1994 — 000.001 — 7
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CHAPTER III
CEMarking
Article 10
1. Recreational craft and componentsasreferred to in Annex II
which are regarded as meeting the essential requirements referred to
in Article 3 must bear the CE marking of conformity when they areplaced on the market.
2. The CE marking of conformity, as shown in Annex IV, must
appear in a visible, legible and indelible form on the recreational craftasin point 2.2 of Annex I and on componentsasreferred to in AnnexII and/or on their packaging.
The CE marking shall be accompanied by the identification number of
the notified body responsible for implementation of the procedures set
out in AnnexesVI, IX, X, XI and XII.
3. The affixing of markingsor ins criptionson 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 beaffixed to the recreational craft and componentsasreferred to in AnnexII and/or on their packaging, provided that the visibility and legibilityof the CE marking isnot thereby reduced.
4. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed wrongly, the manufacturer or hisauthorized repres entativeestablished in the Community shall be obliged to end the infringe-ment under conditionslaid down by the Member State;
(b) where non-compliance continues, the Member State shall take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is withdrawnfrom the market, in accordance with the procedure laid down inArticle 7.
CHAPTER IV
Finalprovisions
Article 11
Detailed grounds shall be given for any decision taken pursuant to this
Directive leading to a restriction on the marketing and putting intoservice of products referred to in Article 1 (1). The party concernedshall be informed of the decision as soon as possible together with themeansof redres savailable under the lawsin force in the Member State
concerned and the periodswithin which appealsmus t be lodged.
Article 12
The Commission shall take the necessary measures to ensure that data
affecting all pertinent decisions concerning the management of thisDirective are made available.
Article 13
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive notlater than 16 December 1995. They shall immediately inform theCommission thereof.
Member States shall apply these provisions from 16 June 1996.The Standing Committee referred to in Article 6 (3) may assume its
tasks from the date of the entry into force of this Directive. MemberStates may take the measures referred to in Article 9 of such date.
When Member States adopt the provisions referred to in the first
subparagraph, these shall contain a reference to this Directive or shall1994L0025 — EN — 30.06.1994 — 000.001 — 8
▼B
be accompanied by such a reference at the time of their official publi-
cation. The procedure for such reference shall be adopted by MemberStates.
2. Member States shall communicate to the Commission the text of
the provisions of national law which they adopt in the field governedby thisDirective.
3. Member Statess hall accept the placing on the market and putting
into service of products referred to in Article 1 (1) which comply withthe rulesin force in their territory on the date of adoption of thisDirec-tive during a period of four yearsfrom that date.
Article 14
ThisDirective s hall enter into force on the day of itspublication in the
Official Journal of the European Communities .
Article 15
This Directive is addressed to the Member States.1994L0025 — EN — 30.06.1994 — 000.001 — 9
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ANNEX I
ESSENTIAL SAFETY REQUIREMENTS FOR THE DESIGN AND
CONSTRUCTIONOFRECREATIONALCRAFT
1. BOAT DESIGN CATEGORIES
Design categoryWind force
(Beaufort scale)Significant wave height
(H⅓, metres)
A — ‘Ocean’ exceeding 8 exceeding 4
B — ‘Offshore’ up to, and including,
8up to, and including, 4
C — ‘Inshore’ up to, and including,
6up to, and including, 2
D — ‘Sheltered
waters’up to, and including,
4up to, and including,
0,5
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, estu-
aries, 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 canalswhere conditionsup to, and including, wind force 4 and
significant wave heights up to, and including, 0,5 m may be experi-
enced.
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, and to have good handling char-
acteristics.
2. GENERAL REQUIREMENTS
Recreational craft and componentsasreferred to in Annex II s hall
comply with the essential requirements in so far as they apply to them.
2.1.Hullidentification
Each craft shall be marked with a hull identification number including the
following information:
— manufacturer'scode,
— country of manufacture,— unique serial number,— year of production,— model year.
The relevant harmonized standard gives details of these requirements.
2.2.Builder'splate
Each craft shall carry a permanently affixed plate mounted separately
from the boat hull identification number, containing the following infor-
mation:
— manufacturer'sname,
— CE marking (see Annex IV),— boat design category according to section 1,— manufacturer'smaximum recommended load according to s ection 3.6,1994L0025 — EN — 30.06.1994 — 000.001 — 10
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— number of persons recommended by the manufacturer for which the
boat wasdes igned to carry when under way.
2.3.Protection fromfallingoverboardandmeansofreboarding
Depending on the design category, craft shall be designed to minimize
the risks of falling overboard and to facilitate reboarding.
2.4.Visibilityfromthemainsteeringposition
For motor boats, the main steering position shall give the operator, under
normal conditions of use (speed and load), good all-round visibility.
2.5.Owner'smanual
Each craft shall be provided with an owner's manual in the official
Community language or languageswhich may be determined by the
Member State in which it ismarketed in accordance with the Treaty.
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 as well
asthe unladen weight of the craft in kilograms .
3. INTEGRITY AND STRUCTURAL REQUIREMENTS
3.1.Structure
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, and the manufacturer's
maximum recommended load in accordance with section 3.6.
3.2.Stabilityandfreeboard
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.
3.3.Buoyancyandflotation
The craft shall be constructed to ensure that it has buoyancy characteris-
tics appropriate to its design category according to section 1.1, and the
manufacturer'smaximum recommended load according to s ection 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
meansof flotation in the s wamped condition.
3.4.Openingsinhull,deckandsuperstructure
Openings in hull, deck(s) and superstructure shall not impair the struc-
tural integrity of the craft or itsweathertight integrity when clos ed.
Windows, portlights, doors and hatchcovers shall withstand the water
pressure likely to be encountered in their specific position, as well as
pointloadsapplied by the weight of pers onsmoving 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, shall be fitted
with shutoff means which shall be readily accessible.
3.5.Flooding
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 pumpsor other means .
3.6.Manufacturer'smaximumrecommendedload
The manufacturer's maximum recommended load (fuel, water, provisions,
miscellaneous equipment and people (in kilograms)) for which the boat1994L0025 — EN — 30.06.1994 — 000.001 — 11
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was designed, as marked on the builder's plate, shall be determined
according to the design category (section 1), stability and freeboard
(section 3.2) and buoyancy and flotation (section 3.3).
3.7.Liferaftstowage
All craft of categoriesA and B, and craft of categoriesC 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.
3.8.Escape
All habitable multihull craft over 12 metreslong s hall be provided with
viable means of escape in the event of inversion.
All habitable craft shall be provided with viable means of escape in the
event of fire.
3.9.Anchoring,mooringandtowing
All craft, taking into account their design category and their characteris-
tics 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
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. INSTALLATION REQUIREMENTS5.1.Enginesandenginespaces
5.1.1.Inboard engine
All inboard mounted engines shall be placed within an enclosure sepa-
rated 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 vibrationsin the living quarters .
Engine parts and accessories that require frequent inspection and/or servi-
cing 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 inletsmus t 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:
(a) when the engine produces less than 500 newtons (N) of static thrust;
(b) when the engine hasa throttle limiting device to limit thrus t to 500 N
at the time of starting the engine.
5.2.Fuelsystem
5.2.1.General
The filling, storage, venting and fuel-supply arrangements and installa-
tions shall be designed and installed so as to minimize the risk of fire
and explosion.1994L0025 — EN — 30.06.1994 — 000.001 — 12
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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 55 ºC 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 55 ºC may be kept in
tanksthat are integral with the hull.
5.3.Electrical system
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.Steeringsystem
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.
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.
5.5.Gassystem
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 explo-
sion 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 hazardsfrom leaksand productsof combus tion.
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.Fire protection
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 areasof 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 and1994L0025 — EN — 30.06.1994 — 000.001 — 13
▼B
one shall be so positioned that it can easily be reached from the main
steering position of the craft.
5.7.Navigationlights
Where navigation lightsare fitted, they s hall comply with the 1972
Colreg or CEVNI regulations, as appropriate.
5.8.Dischargeprevention
Craft shall be constructed so as to prevent the accidental discharge of
pollutants(oil, fuel, etc.) overboard.
Craft fitted with toiletss hall 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.1994L0025 — EN — 30.06.1994 — 000.001 — 14
▼B
ANNEX II
COMPONENTS
1. Ignition-protected equipment for inboard and stern drive engines.
2. Start-in-gear protection devicesfor outboard engines .3. Steering wheels, steering mechanisms and cable assemblies.
4. Fuel tanks and fuel hoses.
5. Prefabricated hatchesand portlights .1994L0025 — EN — 30.06.1994 — 000.001 — 15
▼B
ANNEX III
DECLARATION BY THE BUILDER OR HIS AUTHORIZED REPRE-
SENTATIVE ESTABLISHED IN THE COMMUNITY ORTHE PER SON
RESPONSIBLEFORPLACINGONTHEMARKET
(Article 4(2)and(3))
(a) The declaration by the builder or his authorized representative established in
the Community referred to in Article 4 (2) (partly completed craft) shall
contain the following:
— the name and address of the builder,
— the name and address of the representative of the builder established in
the Community or, if appropriate, of the person responsible for theplacing 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 established in
the Community or the person responsible for placing on the market referred
to in Article 4 (3) (components) shall contain the following:
— the name and address of the builder,
— the name and address of the representative of the builder established in
the Community 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.1994L0025 — EN — 30.06.1994 — 000.001 — 16
▼B
ANNEX IV
CEMARKING
The CE conformity marking must consist of the initials ‘CE’ taking the
following form:
If the marking isreduced or enlarged, the proportionsgiven in the above grad-
uated drawing must be respected.
The various elements of the CE marking must have about the same vertical
dimension, which shall not be less than 5 mm.
The CE marking isfollowed by the identification number of the notified body if
it intervenesin the control of production.1994L0025 — EN — 30.06.1994 — 000.001 — 17
▼C1
▼B
ANNEX V
INTERNALPRODUCTIONCONTROL
(moduleA)
1. The manufacturer or his authorized representative established within the
Community, who carriesout the obligationslaid down in point 2, ens ures
and declares that the products concerned satisfy the requirements of the
Directive that apply to them. The manufacturer or hisauthorized repres enta-
tive established within the Community shall affix the CE marking to each
product and draw up a written declaration of conformity (see Annex XV).
2. The manufacturer shall establish the technical documentation described in
paragraph 3 and he or his authorized representative established within theCommunity 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 autho-
rities for inspection purposes.
Where neither the manufacturer nor his authorized representative is estab-
lished within the Community, the obligation to keep the technical
documentation available shall be the responsibility of the person who places
the product on the Community market.
3. Technical documentation shall enable the conformity of the products with the
requirements of the Directive to be assessed. It shall, as far as relevant for
such assessment, cover the design, manufacture and operation of the product
(see Annex XIII).
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 manu-
facturing process shall ensure compliance of the manufactured products with
the technical documentation referred to in point 2 and with the requirements
of the Directive that apply to them.1994L0025 — EN — 30.06.1994 — 000.001 — 18
▼B
ANNEX VI
INTERNALPRODUCTIONCONTROLPLUSTESTS
(moduleAa,option1)
This module consists of module A, as referred to in Annex V, 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 hisbehalf:
— test of stability according to point 3.2 of the Essential Requirements,
— test of buoyancy characteristics according to point 3.3 of the Essential
Requirements
Provisions common to both variationsThese 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.1994L0025 — EN — 30.06.1994 — 000.001 — 19
▼B
ANNEX VII
ECTYPE-EXAMINATION
(moduleB)
1. A notified body ascertains and attests that a specimen, representative of the
production envisaged, meets the provisions of the Directive that apply to it.
2. The application for the EC type-examination shall be lodged by the manu-
facturer or his authorized representative established within the Community
with a notified body of hischoice.
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 addi-
tion,
— a written declaration that the same application has not been lodged with
any other notified body,
— the technical documentation, asdes cribed in point 3.
The applicant shall place at the disposal of the notified body a specimen,
representative of the production envisaged and hereinafter called ‘type’ (*).
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 Directive to be assessed. It shall, as far as rele-
vant for such assessment, cover the design, manufacture and functioning of
the product (see Annex XIII).
4. The notified body shall:4.1. examine the technical documentation, verify that the type hasbeen manu-
factured in conformity with the technical documentation and identify the
elementswhich have been des igned in accordance with the relevant provi-
sions of the standards referred to in Article 5, as well as the components
which have been designed without applying the relevant provisions of those
standards;
4.2. perform or have performed the appropriate examinations and necessary
tests to check whether, where the standards referred to in Article 5 have
not been applied, the solutions adopted by the manufacturer meet the
Essential Requirements of the Directive;
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 meetsthe provis ionsof the Directive, the notified body
shall issue an EC type-examination certificate to the applicant. The certifi-
cate shall contain the name and address of the manufacturer, conclusions of
the examination, conditions for its validity and the necessary data for iden-
tification 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 isdenied a type certification, the notified body s hall
provide detailed reasons for such denial.
6. The applicant shall inform the notified body that holds the technical docu-
mentation concerning the EC type-examination certificate of all
modificationsto the approved product which mus t receive additional
approval where such changes may affect the conformity with the essential
requirements or the prescribed conditions for use of the product. This addi-
tional approval isgiven in the form of an addition to the original EC type-
examination certificate.1994L0025 — EN — 30.06.1994 — 000.001 — 20
(*) 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
7. Each notified body shall communicate to the other notified bodies the rele-
vant information concerning the EC type-examination certificatesand
additions issued and withdrawn.
8. The other notified bodiesmay receive copiesof the EC type-examination
certificatesand/or their additions . The annexesto the certificatess hall be
kept at the disposal of the other notified bodies.
9. The manufacturer or his authorized representative shall keep with the tech-
nical documentation copiesof EC type-examination certificatesand 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 estab-
lished within the Community, the obligation to keep the technical
documentation available shall be the responsibility of the person who
placesthe product on the Community market.1994L0025 — EN — 30.06.1994 — 000.001 — 21
▼B
ANNEX VIII
CONFORMITYTOTYPE
(moduleC)
1. The manufacturer or his authorized representative established within the
Community ensures and declares that the products concerned are in confor-
mity with the type asdes cribed in the EC type-examination certificate and
satisfy the requirements of the Directive that applies to them. The manufac-
turer shall affix the CE marking to each product and draw up a written
declaration of conformity (see Annex XV).
2. The manufacturer shall take all measures necessary to ensure that the manu-
facturing process assures compliance of the manufactured products with thetype asdes cribed in the EC type-examination certificate and with the require-
mentsof the Directive 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 hasbeen manufactured.
Where neither the manufacturer nor his authorized representative is estab-
lished within the Community, the obligation to keep the technical
documentation available shall be the responsibility of the person who places
the product on the Community market (see Annex XIII).1994L0025 — EN — 30.06.1994 — 000.001 — 22
▼B
ANNEX IX
PRODUCTIONQUALITYASSURANCE
(moduleD)
1. The manufacturer who satisfies the obligations of point 2 ensures and
declaresthat the productsconcerned are in conformity with the type as
described in the EC type-examination certificate and satisfy the require-
mentsof the Directive that apply to them. The manufacturer or his
authorized representative established within the Community shall affix the
CE marking to each product and draw up a written declaration of confor-
mity (see Annex XV). The CE marking shall be accompanied by the
distinguishing number of the notified body responsible for the monitoring
ass pecified in point 4.
2. The manufacturer shall operate an approved quality system for production,
final product inspection and testing as specified in paragraph 3 and shall be
subject to monitoring as specified in point 4.
3.Qualitysystem
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) 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 Directive 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 documen-
tation must permit a consistent interpretation of the quality programmes,
plan, manualsand records .
It shall contain in particular an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powersof the management with regard to product quality,
— the manufacturing, quality control and quality assurance techniques,
processes and systematic actions that will be used,
— the examinationsand tes tsthat 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 reportsof the pers onnel concerned, etc.,
— the meansto 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. It shall presume confor-
mity 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.1994L0025 — EN — 30.06.1994 — 000.001 — 23
▼B
The notified body shall evaluate the modifications proposed and decide
whether the amended quality system will still satisfy the requirements
referred to in paragraph 3.2 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.
4.Surveillanceundertheresponsibilityofthenotifiedbody
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 reportsof the pers onnel 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 manufac-
turer. 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 autho-
rities:
— the documentation referred to in the second indent of the second
subparagraph of point 3.1,
— the updating referred to in the second subparagraph of point 3.4,
— 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.
6. Each notified body shall give the other notified bodies the relevant infor-
mation concerning the quality system approvals issued and withdrawn.1994L0025 — EN — 30.06.1994 — 000.001 — 24
▼B
ANNEX X
PRODUCTVERIFICATION
(moduleF)
1. Thismodule des cribesthe procedure whereby a manufacturer or hisauthor-
ized representative established within the Community checks and attests
that the products subject to the provisions of point 3 are in conformity
with the type asdes cribed in the EC type-examination certificate and
satisfy the requirements of the Directive that apply to them.
2. The manufacturer shall take all measures necessary in order that the manu-
facturing process ensures conformity of the products with the type as
described in the EC type-examination certificate and with the requirementsof the Directive that apply to them. The manufacturer or hisauthorized
representative established within the Community shall affix the CE
marking to each product and shall draw up a declaration of conformity
(see Annex XV).
3. The notified body shall carry out the appropriate examinations and tests in
order to check the conformity of the product with the requirementsof the
Directive either by examination and testing of every product as specified in
point 4 or by examination and testing of products on a statistical basis, as
specified in point 5, at the choice of the manufacturer.
3a. 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 hasbeen manufactured.
4.Verificationbyexaminationandtestingofeveryproduct
4.1. All products shall be individually examined and appropriate tests as set out
in the relevant standard(s) referred to in Article 5 or equivalent tests shall
be carried out in order to verify their conformity with the type asdes cribed
in the EC type-examination certificate and the requirementsof the Direc-
tive 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.
5.Statisticalverification
5.1. The manufacturer shall present his products in the form of homogeneous
lots and shall take all measures necessary in order that the manufacturing
process ensures the homogeneity of each lot produced.
5.2. All productss hall 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 rele-
vant standard(s) referred to in Article 5, or equivalent tests, shall be carried
out to ensure their conformity with the requirements of the Directive which
apply to them and to determine whether the lot isaccepted 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
productsin the lot may be put on the market except thos e productsfrom
the sample which were found not to be in conformity.
If a lot isrejected, the notified body or the competent authority s hall 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 statis-
tical 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.1994L0025 — EN — 30.06.1994 — 000.001 — 25
▼B
ANNEX XI
UNITVERIFICATION
(moduleG)
1. This module describes the procedure whereby the manufacturer ensures and
declares that the product concerned, which has been issued with the certifi-
cate referred to in point 2, conformsto the requirementsof the Directive that
apply to it. The manufacturer or his authorized representative established
within the Community shall affix the CE marking to the product and draw
up a declaration of conformity (see Annex XV).
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 Article5, or equivalent tests, to ensure its conformity with the relevant requirements
of the Directive.
The notified body shall affix, or cause to be affixed, its distinguishing
number on the approved product and shall draw up a certificate of confor-
mity concerning the tests carried out.
3. The aim of the technical documentation isto enable conformity with the
requirements of the Directive to be assessed and the design, manufacture
and operation of the product to be understood (see Annex XIII).1994L0025 — EN — 30.06.1994 — 000.001 — 26
▼B
ANNEX XII
FULLQUALITYASSURANCE
(moduleH)
1. This module describes the procedure whereby the manufacturer who satis-
fiesthe obligationsof paragraph 2 ens uresand declaresthat the products
concerned satisfy the requirements of the Directive that apply to them.
The manufacturer or his authorized representative established within the
Community shall affix the CE marking to each product and draw up a
written declaration of conformity (see Annex XV). The CE marking shall
be accompanied by the distinguishing number of the notified body respon-
sible for the surveillance as specified in point 4.
2. The manufacturer shall operate an approved quality system for design,
manufacture and final product inspection and testing as specified in point
3 and shall be subject to surveillance as specified in point 4.
3.Qualitysystem
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
requirementsof the Directive 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 ofwritten policies, procedures and instructions. This quality system documen-
tation 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 powersof the management with regard to des ign and product
quality,
— the technical design specifications, including standards, that will be
applied and, where the standards referred to in Article 5 will not be
applied in full, the means that will be used to ensure that the essential
requirementsof the Directive that apply to the productswill 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 examinationsand tes tsthat 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 reportsof the pers onnel concerned, etc.,
— the meansto monitor the achievement of the required des ign 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. It shall presume compli-
ance with these requirements in respect of quality systems that implement
the relevant harmonized standard (EN 29001).
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.1994L0025 — EN — 30.06.1994 — 000.001 — 27
▼B
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 paragraph 3.2 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.
4.ECsurveillanceundertheresponsibilityofthenotifiedbody
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 design, manufacture, inspection and testing,
and storage, and shall provide it with all necessary information, in parti-
cular:
— 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 recordsasfores een by the manufacturing part of the quality
system, such as inspection reports and test data, calibration data, quali-
fication reportsof the pers onnel 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 manufac-
turer. 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 autho-
rities:
— the documentation referred to in the second indent of the second
subparagraph of point 3.1,
— the updating referred to in the second subparagraph of point 3.4,
— 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.
6. Each notified body shall forward to the other notified bodies the relevant
information concerning the quality system approvals issued and withdrawn.1994L0025 — EN — 30.06.1994 — 000.001 — 28
▼B
ANNEX XIII
TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFAC-
TURER
The technical documentation referred to in AnnexesV, VII, VIII, IX and XI
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, manufac-
ture and operation of the product, and shall enable assessment of conformity
with the requirementsof thisDirective.
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 draw-
ingsand s chemesand the operation of the product,
— a list of the standards referred to in Article 5, applied in full or in part, and
descriptions of the solutions adopted to fulfil the essential requirements
when the standards referred to in Article 5 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.1994L0025 — EN — 30.06.1994 — 000.001 — 29
▼B
ANNEX XIV
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER
STATESFORTHENOTIFICATIONOFBODIES
1. The body, its director and the staff responsible for carrying out the verifica-
tion 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 author-
ized representatives in the design, construction, marketing or maintenance ofthe said products. This does not preclude the possibility of exchanges of tech-
nical 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 influ-
ence 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 neces-
sary 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 itstas ks(except vis-à-vis
the competent administrative authorities of the State in which its activities
are carried out) under the Directive or any provision of national law giving
effect to it.1994L0025 — EN — 30.06.1994 — 000.001 — 30
▼B
ANNEX XV
WRITTENDECLARATIONOFCONFORMITY
1. The written declaration of conformity to the provisions of the Directive must
alwaysaccompany:
— the recreational craft and be joined to the owner'smanual (Annex I, point
2.5),
— the componentsasreferred to in Annex II.
2. The written declaration of conformity shall include the following (1):
— name and address of the manufacturer or his authorized representative
established in the Community (2),
— description of the recreational craft (3) or of the component (3),
— 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 manufac-
turer or his authorized representative established within the Community.1994L0025 — EN — 30.06.1994 — 000.001 — 31
(1) and be drawn up in the language(s) as foreseen under point 2.5 of Annex I.
(2) business name and full address; authorized representative must also give the business
name and address of the manufacturer.
(3) description of the product make, type, serial number, where appropriate.