DIRECTIVE 94/25/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

EUROPA-PARLAMENTETS OG RAADET DIREKTIV 94/25/EF

of 16 June 1994

af 16. juni 1994

on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft

om indbyrdes tilnaermelse af medlemsstaternes love og administrative bestemmelser om fritidsfartoejer

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

EUROPA-PARLAMENTET OG RAADET FOR DEN EUROPAEISKE UNION HAR -

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

under henvisning til traktaten om oprettelse af Det Europaeiske Faellesskab, saerlig artikel 100 A,

Having regard to the proposal from the Commission (1),

under henvisning til forslag fra Kommissionen (1),

Having regard to the opinion of the Economic and Social Committee (2),

under henvisning til udtalelse fra Det OEkonomiske og Sociale Udvalg (2),

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),

i henhold til fremgangsmaaden i traktatens artikel 189 B (3), og

Whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

ud fra foelgende betragtninger:

Whereas the laws, regulations and administrative provisions in force in the various Member States relating to the safety characteristics of recreational craft differ in scope and content; whereas such disparities are liable to create barriers to trade and unequal conditions of competition within the internal market;

Det indre marked indebaerer et omraade uden indre graenser med fri bevaegelighed for varer, personer, tjenesteydelser og kapital;

Whereas harmonization of national legislation is the only way in which to remove these barriers to free trade; whereas this objective cannot be satisfactorily achieved by the individual Member States; whereas this Directive merely lays down the requirements vital to freedom of movement for recreational craft;

de forskellige medlemsstaters gaeldende love og administrative bestemmelser om fritidsfartoejers sikkerhed afviger fra hinanden i omfang og indhold; disse forskelle kan skabe hindringer for samhandelen og ulige konkurrencevilkaar paa det indre marked;

Whereas this Directive should cover only recreational craft of a minimum length of 2,5 m and a maximum length of 24 m, derived from the ISO standards;

harmonisering af de nationale lovgivninger er den eneste maade, hvorpaa disse hindringer for den frie handel kan fjernes; den enkelte medlemsstat kan ikke alene opfylde dette maal paa tilfredsstillende maade; i dette direktiv fastsaettes der kun krav, som er noedvendige for den frie omsaetning af fritidsfartoejer;

Whereas the removal of technical barriers in the field of recreational craft and their components, to the extent that they cannot be removed by 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 consumer protection, the Commission will take as a base a high level of protection; whereas the essential requirements constitute the criteria with which recreational craft, partly completed craft and their components when separate and when installed must comply;

dette direktiv vedroerer kun fritidsfartoejer med en minimumslaengde paa 2,5 m og en maksimal laengde i henhold til IMO-reglerne og ISO-standarderne paa 24 m;

Whereas, therefore, this Directive sets out essential requirements only; whereas, in order to facilitate the task of proving compliance with the essential requirements, harmonized European standards are necessary for recreational craft and their components as referred to in Annex II; whereas harmonized European standards are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the bodies competent to adopt harmonized standards which follow the general guidelines for cooperation between the Commission and those two bodies, signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical 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 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (5) and pursuant to the general guidelines referred to above;

afskaffelsen af de tekniske handelshindringer for fritidsfartoejer og komponenter dertil boer, i den udstraekning dette ikke kan ske ved gensidig anerkendelse af aekvivalens mellem alle medlemsstaterne, ske ved brug af den nye metode, der er fastsat i Raadets resolution af 7. maj 1985 (4), og hvori der er fastsat en raekke vaesentlige krav vedroerende sikkerhed og andre aspekter, der er af betydning for almenvellet; i artikel 100 A, stk. 3, hedder det, at Kommissionens forslag inden for sundhed, sikkerhed, miljoebeskyttelse og forbrugerbeskyttelse skal bygge paa et hoejt beskyttelsesniveau; de vaesentlige krav udgoer de kriterier, som fritidsfartoejer, delvis faerdigbyggede fartoejer og komponenter dertil, monterede og umonterede, skal opfylde;

Whereas, in view of the nature of the risks involved in the use of recreational craft and their components, it is necessary to establish procedures applying to the assessment of compliance with the essential requirements of the Directive; whereas these procedures must be devised in the light of the level of risk which may be inherent in recreational craft and their components; whereas, therefore, each category of conformity must be supplemented by an appropriate procedure or a choice between several equivalent procedures; whereas the procedures adopted comply with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of 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 technical harmonization Directives (1);

der fastsaettes i dette direktiv derfor kun vaesentlige krav; for at goere det lettere for fabrikanterne at bevise, at de vaesentlige krav er overholdt, er det noedvendigt, at der paa europaeisk plan foreligger harmoniserede standarder for fritidsfartoejer og komponenter dertil; disse harmoniserede standarder paa europaeisk plan udarbejdes af privatretlige organer og skal bevare deres status som ikke-obligatoriske bestemmelser; i denne forbindelse anerkendes Den Europaeiske Standardiseringsorganisation (CEN) og Den Europaeiske Komité for Elektroteknisk Standardisering (CENELEC) som vaerende de organer, der er kompetente til at vedtage de harmoniserede standarder i overensstemmelse med de generelle retningslinjer for samarbejdet mellem Kommissionen og disse to organer, som blev undertegnet den 13. november 1984; i dette direktiv forstaas ved en harmoniseret standard en teknisk specifikation (europaeisk standard eller harmoniseringsdokument), som er vedtaget af et af disse organer eller af dem begge efter mandat fra Kommissionen i overensstemmelse med Raadets direktiv 83/189/EOEF af 28. marts 1983 om en informationsprocedure med hensyn til tekniske standarder og forskrifter (5) samt i henhold til ovennaevnte generelle retningslinjer;

Whereas the Council has provided for the affixing of the CE marking by either the manufacturer or his authorized representative within the Community; whereas that mark means that the recreational craft and components comply with all the essential requirements and assessment procedures provided for by the Community law applying to the product;

i betragtning af de iboende risici ved anvendelse af fritidsfartoejer og komponenter dertil er det noedvendigt at fastlaegge procedurer for evaluering af overensstemmelsen med de vaesentlige krav i direktivet; disse procedurer udformes paa grundlag af den risikograd, som fritidsfartoejer og komponenter dertil repraesenterer; hver overensstemmelseskategori skal derfor suppleres med en adaekvat procedure eller et valg mellem flere aekvivalente procedurer; de udvalgte procedurer skal svare til Raadets afgoerelse 93/465/EOEF af 22. juli 1993 om modulerne for de forskellige faser i procedurerne for overensstemmelsesvurdering og regler om anbringelse og anvendelse af CE-overensstemmelsesmaerkningen, med henblik paa anvendelse i direktiverne om teknisk harmonisering (1);

Whereas it is appropriate that the Member States, as provided 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 craft or constituent products thereof in cases where they present a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure;

Raadet har fastsat, at CE-maerkning skal foretages enten af fabrikanten eller af dennes i Faellesskabet etablerede repraesentant; maerkningen betyder, at fritidsfartoejet og komponenter dertil er i overensstemmelse med alle de vaesentlige krav og evalueringsprocedurerne i de faellesskabsbestemmelser, der gaelder for produktet;

Whereas the recipients of any decision taken as part of this Directive must be aware of the reasons behind that decision and the means of appeal open to them;

det er hensigtsmaessigt, at medlemsstaterne som fastsat i traktatens artikel 100 A, stk. 5, kan traeffe foreloebige foranstaltninger med henblik paa at begraense eller forbyde markedsfoering og anvendelse af fritidsfartoejer eller komponenter, der indgaar deri, saafremt disse udgoer en saerlig risiko for personers og i givet fald husdyrs eller goders sikkerhed, forudsat at disse foranstaltninger er undergivet en faellesskabskontrolprocedure;

Whereas it is necessary to provide for a transitional arrangement enabling recreational craft and their components manufactured in compliance with the national regulations in force at the date of adoption of this Directive to be marketed and placed in service;

begrundelsen for en beslutning i henhold til dette direktiv skal meddeles dem, som beslutningen er rettet til, ligesom de paagaeldende skal have meddelelse om, hvilke klagemuligheder de har;

Whereas this Directive does not contain any provisions directed towards limiting the use of the recreational craft after it has been put into service;

der maa fastsaettes en overgangsordning, saaledes at fritidsfartoejer og komponenter dertil, der er fremstillet i henhold til de nationale regler, der var gaeldende paa tidspunktet for naervaerende direktivs vedtagelse, kan markedsfoeres og tages i brug;

Whereas the construction 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 those provisions concern the construction of recreational craft from the point of view of its direct impact on the environment;

dette direktiv indeholder ingen bestemmelser om begraensning af anvendelsen af fritidsfartoejer, efter at de er taget i brug;

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 on certain waters for the purpose of protection of the environment, the fabric of waterways and ensuring safety on waterways, provided that this does not mean that the recreational craft is modified in a way not specified in this Directive,

bygningen af fritidsfartoejer kan have foelger for miljoeet, idet fartoejerne kan afgive forurenende stoffer; der boer derfor i dette direktiv vaere bestemmelser om beskyttelse af miljoeet, som vedroerer den direkte indvirkning paa miljoeet af bygningen af fritidsfartoejer;

HAVE ADOPTED THIS DIRECTIVE:

bestemmelserne i dette direktiv maa ikke beroere medlemsstaternes ret til under iagttagelse af traktaten at fastsaette krav, som de finder noedvendige vedroerende sejlads i visse farvande for at beskytte miljoeet og vandvejenes struktur og for at sikre sikkerheden paa disse, forudsat at dette ikke kraever, at fritidsfartoejerne skal aendres paa en maade, som ikke er fastsat i dette direktiv -

UDSTEDT FOELGENDE DIREKTIV:

CHAPTER I

KAPITEL 1

Article 1

Artikel 1

1. This Directive shall apply to recreational craft, partly completed boats and components referred to in Annex II when separate and when 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 for charter or for recreational boating training shall not prevent it being covered by this Directive when it is placed on the market for recreational purposes.

1. Dette direktiv finder anvendelse paa fritidsfartoejer, delvis faerdigbyggede fartoejer og de i bilag II naevnte komponenter, i saavel monteret som umonteret stand.

3. The following shall be excluded from the scope of this Directive:

2. Ved fritidsfartoej forstaas i dette direktiv alle typer fartoejer uanset fremdrivningsmidlet, med en skroglaengde paa mellem 2,5 m og 24 m maalt efter den relevante harmoniserede standard, til sports- og fritidsformaal. Det forhold, at samme fartoej kan anvendes til udlejning og til oplaering i lystsejlads, betyder ikke, at det udelukkes fra direktivets anvendelsesomraade, hvis det markedsfoeres til rekreative formaal.

(a) craft intended solely for racing, including rowing racing boats and training rowing boats labelled as such by the manufacturer;

3. Foelgende fartoejer er ikke omfattet af direktivet:

(b) canoes and kayaks, gondolas and pedalos;

a) fartoejer, der udelukkende er konstrueret til kapsejlads, herunder kaproningsbaade og robaade bestemt til traening, og som er betegnet som saadanne af fabrikanten

(c) sailing surfboards;

b) kanoer og kajakker, gondoler og vandcykler

(d) powered surfboards, personal watercraft and other similar powered craft;

c) windsurfingbraetter

(e) original, and individual replicas of, historical craft designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer;

d) motordrevne surfbraetter, »personlige« fartoejer og andre lignende motordrevne fartoejer

(f) experimental craft, provided that they are not subsequently placed on the Community market;

e) originale historiske fartoejer og individuelle reproduktioner af saadanne, der er konstrueret foer 1950, og som hovedsagelig er bygget med originale materialer og er betegnet som saadanne af fabrikanten

(g) craft built for own use, provided that they are not subsequently placed on the Community market during a period of five years;

f) forsoegsfartoejer saafremt de ikke senere markedsfoeres i Faellesskabet

(h) craft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to paragraph 2, in particular those defined in Directive 82/716/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels (2), regardless of the number of passengers;

g) fartoejer, der er bygget til eget brug, saafremt de ikke inden for en periode paa fem aar efter bygningen markedsfoeres i Faellesskabet

(i) submersibles;

h) fartoejer, der specielt er beregnet til at skulle have en besaetning og til at benyttes til erhvervsmaessig passagerbefordring, jf. dog stk. 2, herunder de fartoejer, der er defineret i Raadets direktiv 82/714/EOEF af 4. oktober 1992 om indfoerelse af tekniske forskrifter for fartoejer paa indre vandveje (2), uanset antallet af passagerer

(j) air cushion vehicles;

i) undervandsfartoejer

(k) hydrofoils.

j) luftpudefartoejer

k) hydrofoilfartoejer.

Article 2

Artikel 2

Placing on the market and putting into service

1. Member States shall take all necessary measures to ensure that the products referred to in Article 1 (1) 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.

Markedsfoering og ibrugtagning

2. The provisions of this Directive shall not prevent Member States 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 this Directive.

1. Medlemsstaterne traeffer alle noedvendige foranstaltninger for at sikre, at de i artikel 1, stk. 1, omtalte produkter kun kan markedsfoeres og tages i brug til anvendelse efter deres bestemmelse, hvis de ikke udgoer nogen risiko for personers sikkerhed og sundhed, for goder eller for miljoeet, naar de er korrekt bygget og vedligeholdt.

2. Bestemmelserne i dette direktiv er ikke til hinder for, at medlemsstaterne under iagttagelse af traktaten kan vedtage bestemmelser om sejlads i bestemte farvande for at beskytte miljoeet og vandvejenes infrastruktur og for at sikre vandvejenes sikkerhed, forudsat at dette ikke kraever nogen aendring af fartoejer, der er i overensstemmelse med dette direktiv.

Article 3

Artikel 3

Essential requirements

The products referred to in Article 1 (1) shall meet the essential safety, health, environmental protection and consumer protection requirements set out in Annex I.

Vaesentlige krav

De i artikel 1, stk. 1, omhandlede produkter skal opfylde de vaesentlige krav til sikkerhed, sundhed, miljoebeskyttelse og forbrugerbeskyttelse, der er fastsat i bilag I.

Article 4

Artikel 4

Free movement of the products referred to in Article 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 products referred to in Article 1 (1) bearing the CE marking referred to in Annex IV, which indicates their conformity with all provisions of this Directive, including the conformity procedures set out in Chapter II.

Fri bevaegelighed for de i artikel 1, stk. 1, omhandlede produkter

2. Member States shall not prohibit, restrict or impede the placing on the market of partly-completed boats where the builder or his authorized representative established in the Community or the person responsible for the placing on the market declares, in accordance with Annex IIIA, that they are intended to be completed by others.

1. Medlemsstaterne kan ikke forbyde, begraense eller hindre markedsfoering og ibrugtagning paa deres omraade af fritidsfartoejer, som er forsynet med den i bilag IV naevnte CE-maerkning, der angiver, at de opfylder alle dette direktivs bestemmelser, herunder overensstemmelsesprocedurerne i kapitel II.

3. Member States shall not prohibit, restrict or impede the placing on the market and putting into service of components referred to in Annex II and bearing the CE marking referred to in Annex IV 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 IIIB, of the manufacturer, his authorized representative established in the Community or, in the case of imports from a third country, of any person who places those components on the Community market.

2. Medlemsstaterne kan ikke forbyde, begraense eller hindre markedsfoering af delvis faerdigbyggede fartoejer, saafremt fabrikanten eller dennes i Faellesskabet etablerede repraesentant eller den ansvarlige for markedsfoeringen i overensstemmelse med bilag III, litra a), erklaerer, at de er bestemt til at faerdigbygges af andre.

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 this Directive, 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.

3. Medlemsstaterne kan ikke forbyde, begraense eller hindre markedsfoering eller ibrugtagning af de i bilag II naevnte komponenter, som er forsynet med den i bilag IV naevnte CE-maerkning, der angiver, at de opfylder de relevante vaesentlige krav, saafremt disse komponenter er bestemt til at indgaa i fritidsfartoejer i overensstemmelse med den i bilag III, litra b), omhandlede erklaering fra fabrikanten, dennes i Faellesskabet etablerede repraesentant eller, i tilfaelde af indfoersel fra tredjelande, enhver som markedsfoerer komponenter i Faellesskabet.

5. Where the products referred to in Article 1 (1) are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that such products also fulfil the provisions of those other Directives. However, should one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the product fulfils the provisions only of those Directives 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.

4. Medlemsstaterne modsaetter sig ikke, at der paa messer og udstillinger, ved demonstrationer osv. praesenteres produkter, som er omhandlet i artikel 1, stk. 1, men som ikke er i overensstemmelse med dette direktiv, forudsat at det ved synlig skiltning klart er anfoert, at de paagaeldende produkter hverken kan markedsfoeres eller tages i brug, foerend en saadan overensstemmelse foreligger.

5. Naar produkter, der er omhandlet i artikel 1, stk. 1, samtidig er omfattet af andre direktiver, der vedroerer andre aspekter, og som ogsaa indeholder krav om CE-maerkning, angiver denne maerkning, at produkterne ligeledes opfylder bestemmelserne i de paagaeldende direktiver. Hvis fabrikanten i henhold til et eller flere af disse direktiver frit kan vaelge, hvilken ordning han vil anvende i en overgangsperiode, viser CE-maerkningen imidlertid, at produkterne kun opfylder bestemmelserne i de direktiver, som fabrikanten anvender. I saa fald skal referencerne vedroerende disse direktiver, som offentliggjort i De Europaeiske Faellesskabers Tidende, anfoeres i de dokumenter, vejledninger eller instruktioner, som kraeves i henhold til direktiverne, og som skal ledsage produkterne.

Article 5

Artikel 5

Member States shall presume compliance with the essential requirements referred to in Article 3 of products referred to in Article 1 (1) which meet the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Communities; Member States shall publish the references of such national standards.

Medlemsstaterne anser de vaesentlige krav, der er omhandlet i artikel 3, for opfyldt for fritidsfartoejer, delvis faerdigbyggede fartoejer og komponenter, som er i overensstemmelse med de relevante nationale standarder til gennemfoerelse af de harmoniserede standarder, hvis referencer er offentliggjort i De Europaeiske Faellesskabers Tidende; medlemsstaterne skal offentliggoere referencerne for saadanne nationale standarder.

Article 6

Artikel 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 the essential requirements referred to in Article 3, the Commission or the Member 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 withdrawn from the publications referred to in Article 5.

1. Finder en medlemsstat eller Kommissionen, at de i artikel 5 omhandlede harmoniserede standarder ikke fuldstaendig opfylder de vaesentlige krav i artikel 3, indbringer Kommissionen eller medlemsstaten sagen for det udvalg, der er nedsat ved direktiv 83/189/EOEF, og redegoer for aarsagerne hertil. Udvalget afgiver en hasteudtalelse.

2. The Commission may adopt any appropriate measure with a view to ensuring that this Directive is applied practically in a uniform manner in pursuance of paragraph 3.

Paa baggrund af udvalgets udtalelse underretter Kommissionen medlemsstaterne om, hvorvidt det er noedvendigt at tilbagetraekke de beroerte standarder fra de i artikel 5 omhandlede offentliggoerelser.

3. The Commission shall be assisted by a Standing Committee composed of representatives appointed by the Member States and chaired by a representative from the Commission.

2. Kommissionen kan efter proceduren i stk. 3 vedtage enhver passende foranstaltning med henblik paa at sikre, at den praktiske anvendelse af dette direktiv bliver ensartet.

The Standing Committee shall draw up its own rules of procedure.

3. Kommissionen bistaas af et staaende udvalg sammensat af repraesentanter udpeget af medlemsstaterne og med en repraesentant for Kommissionen som formand.

The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

Det staaende udvalg fastsaetter selv sin forretningsorden.

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 the minutes.

Kommissionens repraesentant forelaegger det staaende udvalg et udkast til de foranstaltninger, der skal traeffes. Udvalget afgiver en udtalelse om dette udkast inden for en frist, som formanden kan fastsaette under hensyn til, hvor meget det paagaeldende spoergsmaal haster, i givet fald ved afstemning.

The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.

Udtalelsen optages i moedeprotokollen; derudover har hver medlemsstat ret til at anmode om, at dens holdning indfoeres i moedeprotokollen.

4. The Standing Committee may, in addition, examine any question concerning the application of this Directive and raised by its chairman, either at the chairman's initiative or at the request of a Member State.

Kommissionen tager stoerst muligt hensyn til udvalgets udtalelse. Den underretter udvalget om, hvorledes den har taget hensyn til dets udtalelse.

4. Det staaende udvalg kan desuden behandle ethvert spoergsmaal vedroerende anvendelsen af dette direktiv, som formanden forelaegger enten paa eget initiativ eller paa anmodning af en medlemsstat.

Article 7

Artikel 7

Safeguard clause

1. Where a Member State ascertains that recreational craft or components referred to in Annex II and bearing the CE marking referred to in Annex IV 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, it 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.

Beskyttelsesklausul

The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision, in particular where non-conformity is the result of:

1. Konstaterer en medlemsstat, at fritidsfartoejer eller de i bilag II omhandlede komponenter dertil, der er forsynet med den i bilag IV beskrevne CE-maerkning, naar de er korrekt bygget, anbragt og vedligeholdt og bruges i overensstemmelse med deres formaal, kan udgoere en fare for personers sikkerhed og sundhed eller for goder eller miljoe, traeffer den alle egnede foreloebige foranstaltninger for at traekke dem tilbage fra markedet eller forbyde eller begraense markedsfoeringen eller ibrugtagningen af dem.

(a) failure to comply with the essential requirements referred to in Article 3;

Medlemsstaten underretter straks Kommissionen om disse foranstaltninger og anfoerer grundene til sin beslutning, herunder navnlig om den manglende overensstemmelse skyldes:

(b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that those standards have been applied;

a) at de i artikel 3 omhandlede vaesentlige krav ikke er opfyldt

(c) shortcomings in the standards referred to in Article 5 themselves.

b) ukorrekt anvendelse af de i artikel 5 omhandlede standarder, for saa vidt disse standarder haevdes at vaere anvendt

2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:

c) mangler ved selve de i artikel 5 omhandlede standarder.

- the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to 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 the Member State which has taken the decision intends to maintain it, and shall initiate the procedure referred to in Article 6 (1),

2. Kommissionen indleder snarest muligt samraad med de beroerte parter. Hvis Kommissionen efter dette samraad konstaterer:

- the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established in the Community.

- at foranstaltningerne er berettigede, giver den straks den medlemsstat, som har taget initiativet, og de oevrige medlemsstater underretning herom. Hvis den i stk. 1 omhandlede beslutning begrundes med en mangel ved selve standarderne, forelaegger Kommissionen efter samraad med de beroerte parter sagen for det i artikel 6, stk. 1, omhandlede udvalg inden to maaneder, saafremt den medlemsstat, der har truffet beslutningen, har til hensigt at fastholde den, og indleder den procedure, der er omhandlet i artikel 6, stk. 1

3. Where a non-complying component referred to in Annex II or craft bears the CE marking, the appropriate measures shall be taken by the Member State which has authority over whomsoever affixed the marking; that Member State shall inform the Commission and the other Member States thereof.

- at foranstaltningerne er uberettigede, giver den straks den medlemsstat, der har taget initiativet, samt fabrikanten eller dennes i Faellesskabet etablerede repraesentant underretning herom.

4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

3. Hvis en i bilag II naevnt komponent eller et fartoej, som ikke er i overensstemmelse, er forsynet med CE-maerkning, traeffer den medlemsstat, under hvis jurisdiktion den der har anbragt maerkningen hoerer, de fornoedne foranstaltninger; medlemsstaten underretter Kommissionen og de oevrige medlemsstater herom.

4. Kommissionen soerger for, at medlemsstaterne holdes underrettet om procedurens forloeb og resultater.

CHAPTER II

Conformity assessment

KAPITEL II

Overensstemmelsesvurdering

Article 8

Artikel 8

Before producing and placing on the market products referred to in Article 1 (1), the manufacturer or his authorized representative established in the Community shall apply the following procedures for boat design categories A, B, C and D as referred to in Section 1 of Annex I.

1. For categories A and B:

Inden produktion eller markedsfoering af de i artikel 1, stk. 1, omhandlede produkter skal fabrikanten eller dennes i Faellesskabet etablerede repraesentant foelge foelgende procedurer for fartoejskonstruktionskategorierne A, B, C og D, jf. punkt 1 i bilag I:

- for boats of less than 12 m hull length: the internal production control plus tests (module Aa) referred to in Annex VI,

1) For kategori A og B:

- for boats from 12 m to 24 m hull length: the EC type-examination (module B) referred to in Annex VII supplemented by module C (type conformity) referred to in Annex VIII, or any of the following modules: B + D, or B + F, or G or H.

- for fartoejer med en skroglaengde paa under 12 m: intern fabrikationskontrol plus proevninger (modul A a), jf. bilag VI

2. For category C:

- for fartoejer med en skroglaengde fra 12 m til 24 m: EF-typeafproevning (modul B), jf. bilag VII, plus typeoverensstemmelse (modul C), jf. bilag VIII, eller et af foelgende moduler: B + D, eller B + F, eller G eller H.

(a) for boats from 2,5 m to 12 m hull length:

2) For kategori C:

- 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,

a) for fartoejer med en skroglaengde fra 2,5 m til 12 m:

- where the harmonized standards relating Sections 3.2 and 3.3 of Annex I are not complied with: the internal production control plus tests (module Aa) referred to in Annex VI.

- hvis de harmoniserede standarder vedroerende punkt 3.2 og 3.3 i bilag I er overholdt: intern fabrikationskontrol (modul A), jf. bilag V

(b) for boats from 12 m to 24 m hull length: the EC type-examination (module B) referred to in Annex VII followed by module C (type conformity) referred to in Annex VIII, or any of the following modules: B + D, or B + F, or G or H.

- hvis de harmoniserede standarder vedroerende punkt 3.2 og 3.3 i bilag I ikke er overholdt: intern fabrikationskontrol plus proevninger (modul A a), jf. bilag VI

3. For category D:

b) for fartoejer med en skroglaengde fra 12 m til 24 m: EF-typeafproevning (modul B), jf. bilag VII, plus typeoverensstemmelse (modul C), jf. bilag VIII, eller et af foelgende moduler: B + D, eller B + F, eller G eller H.

For boats from 2,5 m to 24 m hull length: the internal production control (module A) referred to in Annex V.

3) For kategori D:

4. For components referred to in Annex II: any of the following modules: B + C, or B + D, or B + F, or G or H.

- for fartoejer med en skroglaengde fra 2,5 m til 24 m: intern fabrikationskontrol (modul A), jf. bilag V.

4) For de i bilag II omhandlede komponenter: et af foelgende moduler: B + C, eller B + D, eller B + F, eller G eller H.

Article 9

Artikel 9

Notified bodies

1. Member States shall notify the Commission and other Member States of the bodies which they have appointed to carry out the tasks pertaining to the conformity assessment procedures referred to in Article 8, together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

Bemyndigede organer

The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks 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.

1. Medlemsstaterne underretter Kommissionen og de oevrige medlemsstater om, hvilke organer de har udpeget til at gennemfoere de i artikel 8 naevnte overensstemmelsesvurderingsprocedurer, samt hvilke specifikke opgaver disse organer er udpeget til at varetage, og hvilke identifikationsnumre Kommissionen paa forhaand har tildelt dem.

2. Member States shall apply the criteria laid down in Annex XIV in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonized standards shall be presumed to fulfil those criteria.

Kommissionen offentliggoer i De Europaeiske Faellesskabers Tidende en fortegnelse over de bemyndigede organer samt deres identifikationsnummer og de opgaver, de er bemyndiget til at udfoere. Den soerger for, at denne fortegnelse ajourfoeres.

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 to in Annex XIV. It shall inform the Commission and the other Member States of its action forthwith.

2. Medlemsstaterne skal anvende kriterierne i bilag XIV i forbindelse med vurderingen af de organer, der skal udpeges. Organer, der opfylder de vurderingskriterier, der er fastsat i de relevante harmoniserede standarder, formodes at vaere i overensstemmelse med disse kriterier.

3. En medlemsstat, der har bemyndiget et organ, skal inddrage bemyndigelsen, hvis den konstaterer, at dette organ ikke laengere opfylder kriterierne i bilag XIV. Den underretter straks Kommissionen og de oevrige medlemsstater herom.

CHAPTER III

CE Marking

KAPITEL III

CE-maerkning

Article 10

Artikel 10

1. Recreational craft and components as referred 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 are placed 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 craft as in point 2.2 of Annex I and on components as referred to in Annex II and/or on their packaging.

1. Fritidsfartoejer og de i bilag II naevnte komponenter, der anses for at opfylde de i artikel 3 omhandlede vaesentlige krav, skal, naar de markedsfoeres, vaere forsynet med CE-overensstemmelsesmaerkning.

The CE marking 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.

2. CE-overensstemmelsesmaerkningen som gengivet i bilag IV skal anbringes paa fritidsfartoejer som angivet i punkt 2.2 i bilag I og paa de i bilag II naevnte komponenter og/eller paa deres emballage, saaledes at den er synlig, letlaeselig og ikke kan fjernes.

3. 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 recreational craft and components as referred to in Annex II and/or on their packaging, provided that the visibility and legibility of the CE marking is not thereby reduced.

CE-maerkningen skal ledsages af identifikationsnummeret paa det bemyndigede organ, der er ansvarligt for ivaerksaettelsen af procedurerne i bilag VI, IX, X, XI og XII.

4. Without prejudice to Article 7:

3. Det er ikke tilladt at anbringe maerker eller paaskrifter, der kan vildlede trejdemand med hensyn til CE-maerkningens betydning eller grafiske udformning. Ethvert andet maerke kan anbringes paa fritidsfartoejerne og de i bilag II naevnte komponenter og/eller paa deres emballage, forudsat at dette ikke goer EF-maerkningen mindre synlig eller letlaeselig.

(a) where a Member State establishes that the CE marking has been affixed wrongly, the manufacturer or his authorized representative established in the Community shall be obliged to end the infringement under conditions laid down by the Member State;

4. Foelgende bestemmelser finder anvendelse med forbehold af artikel 7:

(b) where non-compliance continues, the Member State 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 Article 7.

a) hvis en medlemsstat konstaterer, at CE-maerkningen er blevet anbragt uretmaessigt, er fabrikanten eller dennes i Faellesskabet etablerede repraesentant forpligtet til at soerge for, at overtraedelsen bringes til ophoer paa de betingelser, som medlemsstaten har fastsat

b) hvis den manglende overholdelse af bestemmelserne fortsaetter, traeffer medlemsstaten efter fremgangsmaaden i artikel 7 alle noedvendige foranstaltninger for at begraense eller forbyde markedsfoeringen af det paagaeldende produkt og for at sikre, at det traekkes tilbage fra markedet.

CHAPTER IV

Final provisions

KAPITEL IV

Afsluttende bestemmelser

Article 11

Artikel 11

Detailed grounds shall be given for any decision taken pursuant to this Directive leading to a restriction on the marketing and putting into service of products referred to in Article 1 (1). The party concerned shall be informed of the decision as soon as possible together with the means of redress available under the laws in force in the Member State concerned and the periods within which appeals must be lodged.

Enhver afgoerelse, der traeffes i medfoer af dette direktiv, og som medfoerer, at markedsfoering og ibrugtagning af de i artikel 1, stk. 1, omhandlede produkter begraenses, skal noeje begrundes. Afgoerelsen meddeles snarest muligt den beroerte part med angivelse af klagemulighederne i den paagaeldende medlemsstat og fristerne for anvendelse af dem.

Article 12

Artikel 12

The Commission shall take the necessary measures to ensure that data affecting all pertinent decisions concerning the management of this Directive are made available.

Kommissionen traeffer de noedvendige foranstaltninger for at sikre, at alle data, der kan have betydning for beslutninger vedroerende dette direktivs forvaltning, goeres tilgaengelige.

Article 13

Artikel 13

1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 16 December 1995. They shall immediately inform the Commission thereof.

Member States shall apply these provisions from 16 June 1996.

1. Medlemsstaterne vedtager og offentliggoer de love og administrative bestemmelser, der er noedvendige for at efterkomme dette direktiv senest den 16. december 1995. De underretter straks Kommissionen herom.

The Standing Committee referred to in Article 6 (3) may assume its tasks from the date of the entry into force of this Directive. Member States may take the measures referred to in Article 9 of such date.

Medlemsstaterne anvender disse love og administrative bestemmelser fra den 16. juni 1996.

When Member States adopt the provisions referred to in the first subparagraph, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Det Staaende Udvalg, der er omhandlet i artikel 6, stk. 3, kan paabegynde sit arbejde fra datoen for dette direktivs ikrafttraeden. Medlemsstaterne kan traeffe de i artikel 9 naevnte foranstaltninger fra denne dato.

2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive.

Naar medlemsstaterne vedtager de i foerste afsnit naevnte love og administrative bestemmelser, skal de indeholde en henvisning til dette direktiv, eller de skal ved offentliggoerelsen ledsages af en saadan henvisning. De naermere regler for denne henvisning fastsaettes af medlemsstaterne.

3. Member States shall accept the placing on the market and putting into service of products referred to in Article 1 (1) which comply with the rules in force in their territory on the date of adoption of this Directive during a period of four years from that date.

2. Medlemsstaterne meddeler Kommissionen teksten til de nationale retsforskrifter, som de udsteder paa det omraade, der er omfattet af dette direktiv.

3. Medlemsstaterne tillader markedsfoering og ibrugtagning af de i artikel 1, stk. 1, omhandlede produkter, der er i overensstemmelse med de bestemmelser, der gaelder paa deres omraade paa tidspunktet for dette direktivs vedtagelse, i en fireaarig periode regnet fra dette tidspunkt.

Article 14

Artikel 14

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Dette direktiv traeder i kraft paa dagen for offentliggoerelsen i De Europaeiske Faellesskabers Tidende.

Article 15

Artikel 15

This Directive is addressed to the Member States.

Dette direktiv er rettet til medlemsstaterne.

Done at Brussels, 16 June 1994.

For the European Parliament

Udfaerdiget i Bruxelles, den 16. juin 1994.

The President

Paa Europa-Parlamentets vegne

E. KLEPSCH

E. KLEPSCH

For the Council

Formand

The President

Paa Raadets vegne

Y. PAPANTONIOU

Y. PAPANTONIOU

Formand

(1) OJ No C 123, 15. 5. 1992, p. 7.

(2) OJ No C 313, 30. 11. 1992, p. 38.

(1) EFT nr. C 123 af 15. 5. 1992, s. 7.

(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).

(2) EFT nr. C 313 af 30. 11. 1992, s. 38.

(4) OJ No C 136, 4. 6. 1985, p. 1.

(3) Europa-Parlamentets udtalelse af 18. november 1992 (EFT nr. C 337 af 21. 12. 1992, s. 17). Raadets faelles holdning af 16. november 1993 (EFT nr. C 137 af 19. 5. 1994, s. 1). Europa-Parlamentets afgoerelse af 9. marts 1994 (EFT nr. C 91 af 28. 3. 1994).

(5) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 88/182/EEC (OJ No L 81, 26. 3. 1988, p. 75).

(4) EFT nr. C 136 af 4. 6. 1985, s. 1.

(1) OJ No L 220, 30. 8. 1993, p. 23.

(5) EFT nr. L 109 af 26. 4. 1983, s. 8; direktivet er senest aendret ved direktiv 88/182/EOEF (EFT nr. L 81 af 26. 3. 1988, s. 75).

(2) OJ No L 301, 28. 10. 1982, p. 1.

(1) EFT nr. L 220 af 30. 8. 1993, s. 23.

(2) Eft nr. L 301 af 28. 10. 1982, s. 1.

ANNEX I

BILAG I

ESSENTIAL SAFETY REQUIREMENTS FOR THE DESIGN AND CONSTRUCTION OF RECREATIONAL CRAFT

1. BOAT DESIGN CATEGORIES

VAESENTLIGE SIKKERHEDSKRAV FOR KONSTRUKTION OG BYGNING AF FRITIDSFARTOEJER

>TABLE>

1. FARTOEJSKONSTRUKTIONSKATEGORIER:

>TABELPOSITION>

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.

Definitioner:

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.

A. OCEANGAAENDE FARTOEJER: konstrueret med henblik paa laengere sejladser, hvor vindstyrken kan overstige 8 paa Beaufort-skalaen, og den signifikante boelgehoejde kan komme op paa over 4 m, hvorunder disse fartoejer skal kunne klare sig selv.

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.

B. OFFSHORE-FARTOEJER: konstrueret med henblik paa offshore-sejlads, hvor vindstyrken kan komme op paa 8, og den signifikante boelgehoejde kan komme op paa 4 m.

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.

C. KYSTFARTOEJER: konstrueret med henblik paa sejlads i kystfarvande, stoerre bugter, flodmundinger, soeer og floder, hvor vindstyrken kan komme op paa 6, og den signifikante boelgehoejde kan komme op paa 2 m.

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 characteristics.

D. FARTOEJER TIL BESKYTTEDE FARVANDE: konstrueret med henblik paa sejlads paa mindre soeer, floder og kanaler, hvor vindstyrken kan komme op paa 4, og den signifikante boelgehoejde kan komme op paa 0,5 m.

2. GENERAL REQUIREMENTS

Fartoejer i disse kategorier skal vaere konstrueret og bygget saaledes, at de kan modstaa ovennaevnte parametre med hensyn til stabilitet, opdrift og andre relevante vaesentlige krav, der er anfoert i bilag I, og skal have gode manoevreringsegenskaber.

Recreational craft and components as referred to in Annex II shall comply with the essential requirements in so far as they apply to them.

2. GENERELLE FORSKRIFTER

2.1. Hull identification

De i artikel 1, stk. 1, omhandlede produkter skal opfylde de vaesentlige krav, der gaelder for dem.

Each craft shall be marked with a hull identification number including the following information:

2.1. Fartoejsidentifikation

- manufacturer's code,

Alle fartoejer skal vaere forsynet med et skrogidentifikationsnummer omfattende foelgende oplysninger:

- country of manufacture,

- fabrikantens kode

- unique serial number,

- fabrikationsland

- year of production,

- entydigt identificerende serienummer

- model year.

- fabrikationsaar

The relevant harmonized standard gives details of these requirements.

- modelaar.

2.2. Builder's plate

Den relevante harmoniserede standard indeholder detaljer vedroerende disse forskrifter.

Each craft shall carry a permanently affixed plate mounted separately from the boat hull identification number, containing the following information:

2.2. Fabrikantplade

- manufacturer's name,

Hvert fartoej skal vaere forsynet med en fastmonteret plade, der skal anbringes adskilt fra skrogidentifikationsnummeret, og hvorpaa der er angivet foelgende oplysninger:

- CE marking (see Annex IV),

- fabrikantens navn

- boat design category according to section 1,

- CE-maerkning (jf. bilag IV)

- manufacturer's maximum recommended load according to section 3.6,

- fartoejskonstruktionskategori i henhold til punkt 1

- number of persons recommended by the manufacturer for which the boat was designed to carry when under way.

- den af fabrikanten anbefalede maksimale last i henhold til punkt 3.6

2.3. Protection from falling overboard and means of reboarding

- det antal personer, fartoejet er konstrueret til at medfoere under sejlads.

Depending on the design category, craft shall be designed to minimize the risks of falling overboard and to facilitate reboarding.

2.3. Beskyttelse mod risikoen for at falde over bord og bjaergningsmuligheder

2.4. Visibility from the main steering position

Fartoejer skal alt efter konstruktionskategori vaere saaledes konstrueret, at risikoen for at falde over bord er den mindst mulige, og at det er let at komme om bord igen.

For motor boats, the main steering position shall give the operator, under normal conditions of use (speed and load), good all-round visibility.

2.4. Udsyn fra hovedstyrepladsen

2.5. Owner's manual

Fra motorfartoejers hovedstyreplads skal foereren under normale brugsforhold (fart og last) have godt udsyn til alle sider.

Each craft shall be provided with an owner's manual in the official Community language or languages which may be determined by the Member State in which it is marketed 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 as the unladen weight of the craft in kilograms.

2.5. Ejerens instruktionsbog

3. INTEGRITY AND STRUCTURAL REQUIREMENTS

Alle fartoejer skal vaere forsynet med ejerens instruktionsbog paa det eller de officielle faellesskabssprog, som den medlemsstat, hvor fartoejerne markedsfoeres, kan fastsaette under overholdelse af traktaten. Denne instruktionsbog skal specielt henlede opmaerksomheden paa risikoen for brand og bordfyldning og skal indeholde de oplysninger, der er naevnt i punkt 2.2, 3.6 og 4, samt angive fartoejets vaegt uden last stand i kilogram.

3.1. Structure

3. INTEGRITET OG KONSTRUKTIONSFORSKRIFTER

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.

3.1. Struktur

3.2. Stability and freeboard

Materialevalg og materialekombination samt fartoejets konstruktion skal sikre, at det i enhver henseende er staerkt nok. Der skal tages saerligt hensyn til konstruktionskategorien i henhold til punkt 1 og den af fabrikanten anbefalede maksimale last i henhold til punkt 3.6.

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.

3.2. Stabilitet og fribord

3.3. Buoyancy and flotation

Fartoejet skal have tilstraekkelig stabilitet og fribord i forhold til konstruktionskategorien i henhold til punkt 1 og den af fabrikanten anbefalede maksimale last i henhold til punkt 3.6.

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.

3.3. Opdrift og flydeevne

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.

Skroget skal vaere bygget saaledes, at fartoejet har opdriftsegenskaber, der svarer til konstruktionskategorien i henhold til punkt 1 og den af fabrikanten anbefalede maksimale last i henhold til punkt 3.6. Alle beboelige flerskrogsfartoejer skal vaere konstrueret saaledes, at de har tilstraekkelig opdrift til at holde sig flydende, naar de ligger med bunden i vejret.

3.4. Openings in hull, deck and superstructure

Fartoejer paa under 6 m skal udstyres med passende opdriftsmidler, saaledes at de flyder i tilfaelde af bordfyldning, naar de anvendes i overensstemmelse med deres konstruktionskategori.

Openings in hull, deck(s) and superstructure shall not impair the structural integrity of the craft or its weathertight integrity when closed.

3.4. AAbninger i skrog, daek og overbygning

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.

AAbninger i skrog, daek og overbygning maa ikke svaekke fartoejets strukturelle styrke eller dets taethed, naar de er lukket.

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.

Vinduer, kooejer, doere og lugedaeksler skal kunne modstaa det vandtryk, der kan forekomme i deres specifikke placering, samt punktbelastninger, som de paafoeres af vaegten af personer, der bevaeger sig omkring paa daekket.

3.5. Flooding

Udstyr, som gaar gennem skroget, og som er bestemt til at lade vand passere ind eller ud af skroget under den vandlinje, der svarer til den af fabrikanten anbefalede maksimale last, jf. punkt 3.6, skal vaere forsynet med lettilgaengelige lukkemidler.

All craft shall be designed so as to minimize the risk of sinking.

3.5. Bordfyldning

Particular attention should be paid where appropriate to:

Alle fartoejer skal vaere saaledes konstrueret, at risikoen for, at de synker, bliver saa lille som muligt.

- cockpits and wells, which should be self-draining or have other means of keeping water out of the boat interior,

Der skal isaer tages hensyn til:

- ventilation fittings,

- cockpitter og broende, der boer vaere selvlaensende eller forsynet med andre midler til at holde vand ude fra baadens indre

- removal of water by pumps or other means.

- ventilationsudstyr

3.6. Manufacturer's maximum recommended load

- laensning med pumper eller andre midler.

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 1), stability and freeboard (section 3.2) and buoyancy and flotation (section 3.3).

3.6. Den af fabrikanten anbefalede maksimale last

3.7. Liferaft stowage

Den af fabrikanten anbefalede maksimale last (i kilogram) af braendstof, vand, forsyninger, forskellig udrustning og personer, som fartoejet er konstrueret til ifoelge fabrikantpladen, fastsaettes ud fra konstruktionskategori (punkt 1), stabilitet og fribord (punkt 3.2) samt opdrift og flydeevne (punkt 3.3).

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.

3.7. Anbringelse af redningsflaader

3.8. Escape

Alle fartoejer i kategori A og B samt fartoejer i kategori C og D paa over 6 m skal have plads til stuvning af en eller flere redningsflaader, som er store nok til at rumme det af fabrikanten anbefalede antal personer, som baaden er konstrueret til at have om bord. Anbringelsesstedet eller -stederne skal til enhver tid vaere lettilgaengelige.

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

3.8. Noedudgange

All habitable craft shall be provided with viable means of escape in the event of fire.

Alle beboelige flerskrogsfartoejer paa over 12 m skal have noedudgange, der kan bruges, hvis fartoejet vender bunden i vejret.

3.9. Anchoring, mooring and towing

Alle beboelige fartoejer skal have noedudgange, der kan bruges i tilfaelde af brand.

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.

3.9. Forankring, fortoejning og bugsering

4. HANDLING CHARACTERISTICS

Alle fartoejer skal under hensyntagen til deres konstruktionskategori og egenskaber vaere forsynet med et eller flere forstaerkede punkter eller andre midler til sikker fastgoerelse ved forankring, fortoejning og bugsering.

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.

4. MANOEVRERINGSEGENSKABER

5. INSTALLATION REQUIREMENTS

Fabrikanten skal sikre, at fartoejets manoevreringsegenskaber er tilfredsstillende ved brug af den kraftigste motor, det er konstrueret og bygget til. For alle motorer til fritidsfartoejer skal den maksimale effekt angives i ejerens instruktionsbog i overensstemmelse med den harmoniserede standard.

5.1. Engines and engine spaces

5. MONTERINGSFORSKRIFTER

5.1.1. Inboard engine

5.1. Motorer og motorrum

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.

5.1.1. Indenbordsmotor

Engine parts and accessories that require frequent inspection and/or servicing shall be readily accessible.

Alle indenbordsmotorer skal vaere anbragt i et aflukke, adskilt fra opholdsafdelingen og saaledes, at risikoen for brand eller spredning af brand samt risikoen for giftige dampe, varme, stoej eller vibrationer i opholdsafdelingen er saa lille som muligt.

The insulating materials inside engine spaces shall be non-combustible.

Motordele og -tilbehoer, der kraever hyppig kontrol og/eller tilsyn, skal vaere lettilgaengelige.

5.1.2. Ventilation

De isolerende materialer i motorrummet skal vaere ubraendbare.

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

5.1.2. Ventilation

5.1.3. Exposed parts

Motorrummet skal vaere passende ventileret. Alle luftaabninger skal sikres mod indtraengning af vand i motorrummet.

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.

5.1.3. Udragende dele

5.1.4. Outboard engines starting

Hvis motoren ikke er beskyttet af overdaekning eller afskaermning, skal udragende bevaegelige eller varme motordele, som kan foraarsage personskade, vaere effektivt afskaermet.

All boats with outboard engines shall have a device to prevent starting the engine in gear, except:

5.1.4. Start af udenbordsmotorer

(a) when the engine produces less than 500 newtons (N) of static thrust;

Alle fartoejer med udenbordsmotorer skal vaere forsynet med en anordning, der forhindrer start af motoren, medens denne staar i gear, undtagen:

(b) when the engine has a throttle limiting device to limit thrust to 500 N at the time of starting the engine.

a) hvis motoren frembringer et statisk skruetryk paa mindre end 500 N

5.2. Fuel system

b) hvis motoren er fornsynet med en gasgivningsbegraenser, der begraenser skruetrykket til 500 N ved start af motoren.

5.2.1. General

5.2. Braendstofsystem

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.

5.2.1. Generelt

5.2.2. Fuel tanks

Udstyr og installationer til paafyldning og ventilation af braendstoftanken, opbevaring af braendstof samt braendstofforsyning skal vaere konstrueret og installeret saaledes, at risikoen for brand og eksplosioner mindskes mest muligt.

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.

5.2.2. Braendstoftanke

Liquid fuel with a flash point below 55 °C shall be kept in tanks which do not form part of the hull and are:

Braendstoftanke, ledninger og slanger skal fastgoeres og vaere fjernt fra eller beskyttet mod enhver stoerre varmekilde. Ved valg af tankmateriale og tankenes udfoerelse skal der tages hensyn til tankvolumenet og braendstoftypen. Alle tankrum skal vaere ventilerede.

(a) insulated from the engine compartment and from all other source of ignition;

Flydende braendstof med et flammepunkt under 55 °C skal opbevares i tanke, der ikke er en del af skroget, og vaere:

(b) separated from living quarters.

a) adskilt fra motorrummet og fra enhver anden taendkilde

Liquid fuel with a flash point equal to or above 55 °C may be kept in tanks that are integral with the hull.

b) adskilt fra opholdsafdelingen.

5.3. Electrical system

Flydende braendstof med et flammepunkt paa eller over 55 °C kan opbevares i tanke, der er en del af skroget.

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.

5.3. Det elektriske system

Attention shall be paid to the provision of overload and short-circuit protection of all circuits, except engine starting circuits, supplied from batteries.

Det elektriske system skal vaere konstrueret og installeret saaledes, at fartoejet fungerer korrekt under normale brugsforhold, og at risikoen for brand og elektriske stoed er saa lille som muligt.

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.

Alle elektriske kredsloeb, undtagen motorstartkredsloebene, der forsynes fra batterier, skal beskyttes mod overbelastning og kortslutning.

5.4. Steering system

Der skal vaere ventilation for at forhindre eventuel ophobning af gas fra batterierne. Batterierne skal vaere forsvarligt fastgjort og beskyttet mod vandindtraengning.

5.4.1. General

5.4. Styresystem

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

5.4.1. Generelt

5.4.2. Emergency arrangements

Styresystemet skal vaere konstrueret, udfoert og installeret saaledes, at styreudslag kan overfoeres under driftsforhold, der er til at forudse.

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.

5.4.2. Noedudstyr

5.5. Gas system

Sejlbaade og fartoejer med en enkelt indenbords motor og fjernstyret styresystem skal vaere forsynet med noedstyringsudstyr, hvormed fartoejet kan styres med nedsat hastighed.

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.

5.5. Gasanlaeg

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.

Gasanlaeg til husholdningsbrug skal vaere af en type, som anvender gas i fordampet form, og vaere konstrueret og installeret saaledes, at laekage og eksplosionsfare undgaas, og at de kan undersoeges for laekager. De anvendte materialer og dele skal vaere egnet til brug af den benyttede gas og vaere konstrueret til at kunne modstaa de ydre paavirkninger, de kan blive udsat for til soes.

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.

Alle apparater skal vaere forsynet med taendsikring, der virker paa alle braendere. Hvert enkelt gasforbrugende apparat skal forsynes fra distributionssystemet via en separat stikledning, og hvert apparat skal have egen afspaerringshane. Der skal vaere saa god en ventilation, at der ikke opstaar fare som foelge af laekager og forbraendningsprodukter.

5.6. Fire protection

Alle fartoejer med permanent installerede gasanlaeg skal have et aflukke til opbevaring af gasflaskerne. Aflukket skal vaere adskilt fra opholdsafdelingen; der maa kun vaere adgang dertil fra det fri, og det skal vaere ventileret til det fri, saaledes at udslip af gas ledes udenbords. Alle permanente gasanlaeg skal afproeves efter installering.

5.6.1. General

5.6. Brandbeskyttelse

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.

5.6.1. Generelt

5.6.2. Fire-fighting equipment

Ved valget af den type udstyr, der installeres, og ved fartoejets indretning skal der tages hensyn til risikoen for brand og for spredning af brand. Der skal laegges saerlig vaegt paa omgivelserne omkring apparater, der bruger aaben ild, paa varme omraader eller motorer og hjaelpemaskiner, paa olie- og braendstofoverloeb og utildaekkede olie- og braendstofroer; det skal ligeledes undgaas, at elektriske ledninger installeres over varme maskinomraader.

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.

5.6.2. Brandslukningsudstyr

5.7. Navigation lights

Fartoejerne skal vaere forsynet med brandslukningsudstyr, der svarer til brandrisikoen. Benzinmotoraflukker skal sikres med et saadant brandslukningssystem, at det ikke er noedvendigt at aabne aflukket i tilfaelde af brand. Transportable ildslukkere skal monteres saaledes, at de er lettilgaengelige, og én ildslukker skal vaere placeret saaledes, at den uden besvaer kan naas fra fartoejets hovedstyreplads.

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

5.7. Skibslys

5.8. Discharge prevention

Naar der monteres skibslys, skal de vaere i overensstemmelse med enten COL REG-bestemmelserne fra 1972 med senere aendringer eller CEVNI-bestemmelserne.

Craft shall be constructed so as to prevent the accidental discharge of pollutants (oil, fuel, etc.) overboard.

5.8. Forebyggelse af udledning

Craft fitted with toilets shall have either:

Fartoejerne skal vaere bygget saaledes, at utilsigtet udledning i havet af forurenende affald (olie, braendstof etc.) forhindres.

(a) holding tanks; or

Fartoejer med toiletter skal vaere udstyret med:

(b) provision to fit holding tanks on a temporary basis in areas of use where the discharge of human waste is restricted.

a) spildevandstanke, eller

In addition, any through-the-hull pipes for human waste shall be fitted with valves which are capable of being sealed shut.

b) anordninger, hvor spildevandstanke midlertidigt kan anbringes, naar fartoejet anvendes i omraader, hvor udledning af menneskelige udtoemmelser er reguleret.

Endvidere skal roer gennem skroget til udledning af menneskelige udtoemmelser vaere forsynet med ventiler, der kan lukke taet.

ANNEX II

BILAG II

COMPONENTS

1. Ignition-protected equipment for inboard and stern drive engines.

KOMPONENTER

2. Start-in-gear protection devices for outboard engines.

1. Udstyr til indenbords motorer og paahaengsmotorer, som er sikret mod at antaende.

3. Steering wheels, steering mechanisms and cable assemblies.

2. Beskyttelse af udenbords motorer mod start, medens motoren staar i gear.

4. Fuel tanks and fuel hoses.

3. Rat, styremekanismer og kabelaggregater.

5. Prefabricated hatches and portlights.

4. Braendstoftanke og braendstofledninger.

5. Praefabrikerede luger og kooejer.

ANNEX III

BILAG III

DECLARATION BY THE BUILDER OR HIS AUTHORIZED REPRESENTATIVE ESTABLISHED IN THE COMMUNITY OR THE PERSON RESPONSIBLE FOR PLACING ON THE MARKET

(Article 4 (2) and (3))

ERKLAERING FRA FABRIKANTEN ELLER DENNES I FAELLESSKABET ETABLEREDE REPRAESENTANT ELLER DEN ANSVARLIGE FOR MARKEDSFOERINGEN

(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:

(artikel 4, stk. 2 og 3)

- the name and address of the builder,

a) Den erklaering fra fabrikanten, dennes i Faellesskabet etablerede repraesentant eller den ansvarlige for markedsfoeringen, der er naevnt i artikel 4, stk. 2 (delvis faerdigbyggede fartoejer), skal indeholde foelgende oplysninger:

- 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,

- navn og adresse paa fabrikanten

- a description of the partly completed craft,

- navn og adresse paa fabrikantens i Faellesskabet etablerede repraesentant eller, eventuelt, paa den ansvarlige for markedsfoeringen

- 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.

- en beskrivelse af det delvis faerdigbyggede fartoej

(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:

- en erklaering om, at det delvis faerdigbyggede fartoej er bestemt til at faerdigbygges af andre, og at det opfylder de vaesentlige krav, som stilles paa dette trin i konstruktionen.

- the name and address of the builder,

b) Den erklaering fra fabrikanten, dennes i Faellesskabet etablerede repraesentant eller den ansvarlige for markedsfoeringen, der er naevnt i artikel 4, stk. 3 (komponenter), skal indeholde foelgende oplysninger:

- 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,

- navn og adresse paa fabrikanten

- a description of the component,

- navn og adresse paa fabrikantens i Faellesskabet etablerede repraesentant eller, eventuelt, paa den ansvarlige for markedsfoeringen

- a statement that the component complies with the relevant essential requirements.

- en beskrivelse af komponenten

- en erklaering om, at komponenten opfylder de relevante vaesentlige krav.

ANNEX IV

BILAG IV

CE MARKING

The CE conformity marking must consist of the initials 'CE' taking the following form:

CE-MAERKNING

>REFERENCE TO A GRAPHIC>

CE-overensstemmelsesmaerkningen bestaar af bogstaverne »CE« i foelgende udformning:

If the marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

>REFERENCE TIL EN GRAFIK>

The various elements of the CE marking must have about the same vertical dimension, which shall not be less than 5 mm.

Hvis CE-maerkningen formindskes eller forstoerres, skal modellens stoerrelsesforhold, som anfoert ovenfor, overholdes.

The CE marking is followed by the identification number of the notified body, if it intervenes in the control of production, as well as by the last two figures of the year that the CE marking is affixed.

De forskellige dele, der indgaar i CE-maerkningen, skal saa vidt muligt vaere af samme hoejde, og denne skal mindst vaere 5 mm.

CE-maerkningen skal efterfoelges af det bemyndigede organs identifikationsnummer, naar organet deltager i produktionskontrollen, samt af de sidste to tal i aaret for maerkningens anbringelse.

ANNEX V

BILAG V

INTERNAL PRODUCTION CONTROL (module A)

1. The manufacturer or his authorized representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that 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).

INTERN FABRIKATIONSKONTROL (modul A)

2. The manufacturer shall establish the technical documentation described in paragraph 3 and he or his authorized representative established within the Community 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.

1. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant, der opfylder forpligtelserne i punkt 2, garanterer og erklaerer, at de paagaeldende produkter opfylder de krav i direktivet, der gaelder for dem. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant anbringer CE-maerkningen paa hvert enkelt produkt og udsteder en skriftlig overensstemmelseserklaering (jf. bilag XV).

Where neither the manufacturer nor his authorized representative is established 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.

2. Fabrikanten udarbejder den tekniske dokumentation, der er beskrevet i punkt 3, og fabrikanten eller dennes i Faellesskabet etablerede repraesentant stiller den til raadighed for de nationale myndigheder med henblik paa inspektion i mindst ti aar fra datoen for ophoeret med fremstillingen af produktet.

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).

Er hverken fabrikanten eller dennes repraesentant etableret i Faellesskabet, paahviler pligten til at fremlaegge den tekniske dokumentation den person, som er ansvarlig for markedsfoeringen af produktet i Faellesskabet.

4. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity with the technical documentation.

3. Den tekniske dokumentation skal goere det muligt at vurdere produktets overensstemmelse med direktivets krav. Dokumentationen skal, i det omfang det er noedvendigt for vurderingen, daekke produktets konstruktion, fremstilling og funktion (jf. bilag XIII).

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 and with the requirements of the Directive that apply to them.

4. Fabrikanten eller dennes repraesentant opbevarer sammen med den tekniske dokumentation en kopi af overensstemmelseserklaeringen.

5. Fabrikanten traeffer alle noedvendige foranstaltninger for, at fremstillingsprocessen sikrer, at de fremstillede produkter er i overensstemmelse med den tekniske dokumentation, der er omhandlet i punkt 2, og med de krav i direktivet, der gaelder for dem.

ANNEX VI

BILAG VI

INTERNAL PRODUCTION CONTROL PLUS TESTS (module Aa, option 1)

This module consists of module A, as referred to in Annex V, plus the following supplementary requirements:

INTERN FABRIKATIONSKONTROL (modul A a, valgmulighed I)

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:

Dette modul svarer til modul A, jf. bilag V, plus foelgende supplerende krav:

- test of stability according to point 3.2 of the Essential Requirements,

Paa et eller flere fartoejer, som er repraesentative for fabrikantens produktion, udfoeres der af fabrikanten eller paa hans vegne en eller flere af foelgende proevninger eller dertil svarende beregninger eller former for kontrol:

- test of buoyancy characteristics according to point 3.3 of the Essential Requirements

- stabilitetsproevning i overensstemmelse med bilag I, punkt 3.2, i de vaesentlige krav

Provisions common to both variations

- opdriftsproevning i overensstemmelse med bilag I, punkt 3.3, i de vaesentlige krav.

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.

Proevningerne, beregningerne eller kontrollen udfoeres under ansvar af et bemyndiget organ, udvalgt af fabrikanten. Under fremstillingsprocessen anbringer fabrikanten paa det bemyndigede organs ansvar dettes identifikationsnummer paa produktet.

ANNEX VII

BILAG VII

EC TYPE-EXAMINATION (module B)

EF-TYPEAFPROEVNING (modul B)

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.

1. Et bemyndiget organ konstaterer og attesterer, at en proeve, som er repraesentativ for den paagaeldende produktion, opfylder de relevante krav i direktivet.

2. The application for the EC type-examination shall be lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice.

2. Anmodning om EF-typeafproevning indgives af fabrikanten eller dennes i Faellesskabet etablerede repraesentant til et bemyndiget organ efter eget valg.

The application shall include:

Anmodningen skal indeholde:

- the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address in addition,

- fabrikantens navn og adresse samt navn og adresse paa fabrikantens repraesentant, hvis anmodningen indgives af denne

- a written declaration that the same application has not been lodged with any other notified body,

- en skriftlig erklaering om, at samme anmodning ikke er indgivet til andre bemyndigede organer

- the technical documentation, as described in point 3.

- den tekniske dokumentation, jf. punkt 3.

The applicant shall place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called 'type' (*).

Ansoegeren stiller en proeve, som er repraesentativ for den paagaeldende produktion, og som i det foelgende benaevnes »type« (*), til raadighed for det bemyndigede organ. Det bemyndigede organ kan anmode om yderligere proever, saafremt dette er noedvendigt af hensyn til gennemfoerelsen af proevningsprogrammet.

The notified body may request further specimens if needed for carrying out the test programme.

3. Den tekniske dokumentation skal goere det muligt at vurdere produktets overensstemmelse med direktivets krav. I det omfang det er noedvendigt for vurderingen, skal den omfatte produktets konstruktion, fremstilling og funktion (jf. bilag XIII).

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 relevant for such assessment, cover the design, manufacture and functioning of the product (see Annex XIII).

4. Det bemyndigede organ:

4. The notified body shall:

4.1. undersoeger den tekniske dokumentation, kontrollerer, at typen er fremstillet i overensstemmelse med denne, og fastslaar, hvilke elementer der er konstrueret i overensstemmelse med de relevante bestemmelser i de i artikel 5 naevnte standarder, samt hvilke elementer der er konstrueret, uden at de relevante bestemmelser i disse standarder er blevet anvendt

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 Article 5, as well as the components which have been designed without applying the relevant provisions of those standards;

4.2. gennemfoerer eller lader gennemfoere de noedvendige undersoegelser og proevninger til kontrol af, om fabrikantens loesninger opfylder de vaesentlige krav i direktivet i de tilfaelde, hvor de i artikel 5 naevnte standarder ikke er anvendt

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. gennemfoerer eller lader gennemfoere de noedvendige undersoegelser og proevninger til kontrol af, om de relevante standarder rent faktisk er blevet anvendt i de tilfaelde, hvor fabrikanten har valgt at anvende dem

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. aftaler med ansoegeren, hvor undersoegelserne og de noedvendige proevninger skal gennemfoeres.

4.4. agree with the applicant the location where the examinations and necessary tests shall be carried out.

5. Konstateres det, at typen opfylder direktivets bestemmelser, udsteder det bemyndigede organ en EF-typeafproevningsattest til ansoegeren. Attesten skal indeholde fabrikantens navn og adresse, undersoegelsens resultater, betingelserne for dens gyldighed samt de noedvendige data til identificering af den godkendte type.

5. Where the type meets the provisions of the Directive, 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.

En oversigt over de relevante dele af den tekniske dokumentation vedlaegges attesten, og en kopi heraf opbevares af det bemyndigede organ.

A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.

Afslaar det bemyndigede organ at udstede en typeafproevningsattest til fabrikanten, skal det give en detaljeret redegoerelse for aarsagerne hertil.

If the manufacturer is denied a type certification, the notified body shall provide detailed reasons for such denial.

6. Ansoegeren skal underrette det bemyndigede organ, som opbevarer den tekniske dokumentation vedroerende EF-typeafproevningen, om enhver aendring af det godkendte produkt; dette skal godkendes paa ny, hvis aendringerne kan paavirke overensstemmelsen med de vaesentlige krav eller de foreskrevne betingelser for anvendelse af produktet. Denne tillaegsgodkendelse gives i form af en tilfoejelse til den oprindelige EF-typeafproevningsattest.

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. Alle bemyndigede organer meddeler de oevrige bemyndigede organer relevante oplysninger om udstedte EF-typeafproevningsattester og udstedte eller tilbagekaldte tillaegsgodkendelser.

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. De oevrige bemyndigede organer kan indhente kopi af EF-typeafproevningsattesterne og/eller tillaegsgodkendelserne. Bilagene til attesterne stilles til de oevrige bemyndigede organers raadighed.

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. Fabrikanten eller dennes repraesentant skal ud over den tekniske dokumentation tillige opbevare en kopi af EF-typeafproevningsattesten og eventuelle tillaeg til denne i mindst ti aar fra datoen for ophoeret af fremstillingen af produktet.

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.

Er hverken fabrikanten eller dennes repraesentant etableret i Faellesskabet, paahviler pligten til at fremlaegge den tekniske dokumentation den person, som er ansvarlig for markedsfoeringen af produktet i Faellesskabet.

Where neither the manufacturer nor his authorized representative is established 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.

(*) En type kan omfatte flere forskellige produktvarianter, naar blot forskellene mellem varianterne ikke beroerer sikkerhedsniveauet eller de oevrige krav til produktets kvalitet.

(*) 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.

BILAG VIII

ANNEX VIII

TYPEOVERENSSTEMMELSE (modul C)

CONFORMITY TO TYPE (module C)

1. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant garanterer og erklaerer, at de paagaeldende produkter er i overensstemmelse med den type, som er beskrevet i EF-typeafproevningsattesten, og opfylder de krav i direktivet, der gaelder for dem. Fabrikanten anbringer CE-maerkningen paa hvert enkelt produkt og udsteder en skriftlig overensstemmelseserklaering (jf. bilag XV).

1. The manufacturer or his authorized representative established within the Community 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 Directive that applies to them. The manufacturer shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV).

2. Fabrikanten traeffer alle noedvendige foranstaltninger for, at fremstillingsprocessen sikrer, at de fremstillede produkter er i overensstemmelse med den type, som er beskrevet i EF-typeafproevningsattesten, og med de relevante krav i direktivet.

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 Directive that apply to them.

3. Fabrikanten eller dennes repraesentant skal opbevare en kopi af overensstemmelseserklaeringen i mindst ti aar fra datoen for ophoeret af fremstillingen af produktet.

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.

Er hverken fabrikanten eller dennes repraesentant etableret i Faellesskabet, paahviler pligten til at fremlaegge den tekniske dokumentation den person, som er ansvarlig for markedsfoeringen af produktet i Faellesskabet (jf. bilag XIII).

Where neither the manufacturer nor his authorized representative is established 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).

BILAG IX

ANNEX IX

KVALITETSSIKRING AF PRODUKTIONEN (modul D)

PRODUCTION QUALITY ASSURANCE (module D)

1. En fabrikant, der opfylder bestemmelserne i punkt 2, garanterer og erklaerer, at de paagaeldende produkter er i overensstemmelse med typen som beskrevet i EF-typeafproevningsattesten og opfylder de krav i direktivet, der gaelder for dem. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant anbringer CE-maerkningen paa hvert enkelt produkt og udsteder en skriftlig overensstemmelseserklaering (jf. bilag XV). Sammen med CE-maerkningen anfoeres det identifikationsnummer, der anvendes af det bemyndigede organ, som er ansvarligt for den i punkt 4 omhandlede kontrol.

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 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 responsible for the monitoring as specified in point 4.

2. Fabrikanten skal anvende et godkendt kvalitetssystem for produktion og foretage kontrol og proevninger af de faerdige produkter som beskrevet i punkt 3, og er underlagt den i punkt 4 omhandlede kontrol.

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. Kvalitetssystem

3. Quality system

3.1. Fabrikanten indsender en ansoegning om vurdering af kvalitetssystemet for de paagaeldende produkter til et bemyndiget organ efter eget valg.

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.

Ansoegningen skal indeholde:

The application shall include:

- alle oplysninger, der er relevante for den planlagte produktkategori

- all relevant information for the product category envisaged,

- dokumentation vedroerende kvalitetssystemet

- the documentation concerning the quality system,

- i givet fald den tekniske dokumentation for den godkendte type (jf. bilag XIII) og en kopi af EF-typeafproevningsattesten.

- where appropriate, the technical documentation of the approved type (see Annex XIII) and a copy of the EC type-examination certificate.

3.2. Kvalitetssystemet skal sikre, at produkterne er i overensstemmelse med den type, som er beskrevet i EF-typeafproevningsattesten, samt med de relevante krav i direktivet.

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.

Alle de forhold, krav og bestemmelser, som fabrikanten har taget hensyn til, skal dokumenteres paa systematisk og overskuelig maade i en skriftlig redegoerelse for forholdsregler, procedurer og instruktioner. Denne dokumentation vedroerende kvalitetssystemet skal sikre, at kvalitetsprogrammer, -planer, -manualer og -registre fortolkes ens.

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.

Redegoerelsen skal navnlig indeholde en fyldestgoerende beskrivelse af:

It shall contain in particular an adequate description of:

- kvalitetsmaalsaetninger og organisationsstruktur sam ledelsens ansvar og befoejelser med hensyn til produktkvalitet

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,

- fremstillingsprocesser, teknikker vedroerende kvalitetskontrol og -sikring samt de systematiske foranstaltninger, der vil blive anvendt

- the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

- de undersoegelser og proevninger, der skal udfoeres foer, under og efter fremstillingen, og den hyppighed, hvormed dette sker

- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

- kvalitetsregistre, herunder kontrolrapporter og proevnings- og kalibreringsdata, rapporter over personalets kvalifikationer mv.

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

- hvordan det kontrolleres, at den kraevede produktkvalitet er opnaaet, og at kvalitetssystemet fungerer effektivt.

- the means to monitor the achievement of the required product quality and the effective operation of the quality system.

3.3. Det bemyndigede organ vurderer kvalitetssystemet for at fastslaa, om det opfylder kravene i punkt 3.2. Organet skal antage, at disse krav er opfyldt, hvis kvalitetssystemerne anvender den harmoniserede standard paa omraadet.

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 conformity with these requirements in respect of quality systems that implement the relevant harmonized standard.

Kontrolholdet skal mindst omfatte ét medlem, som har erfaring med at vurdere den paagaeldende produktteknologi. Vurderingsproceduren skal omfatte et besoeg paa fabrikantens anlaeg.

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.

Afgoerelsen skal meddeles fabrikanten. Meddelelsen skal indeholde resultaterne af undersoegelsen og den begrundede vurderingsafgoerelse.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. Fabrikanten forpligter sig til at opfylde sine forpligtelser i henhold til kvalitetssystemet, saaledes som det er godkendt, og til at vedligeholde det, saaledes at det forbliver hensigtsmaessigt og effektivt.

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.

Fabrikanten eller dennes repraesentant underretter det bemyndigede organ, som har godkendt kvalitetssystemet, om enhver paataenkt aendring af kvalitetssystemet.

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.

Det bemyndigede organ vurderer foreslaaede aendringer og afgoer, om det aendrede kvalitetssystem stadig opfylder de i punkt 3.2 omhandlede krav, eller om en fornyet vurdering er noedvendig.

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.

Det bemyndigede organ meddeler fabrikanten afgoerelsen. Meddelelsen skal indeholde resultaterne af undersoegelsen og den begrundede vurderingsafgoerelse.

It shall notify its decisions to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Kontrol paa det bemyndigede organs ansvar

4. Surveillance under the responsibility of the notified body

4.1. Formaalet med kontrollen er at sikre, at fabrikanten fuldt ud opfylder sine forpligtelser i henhold til det godkendte kvalitetssystem.

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. Fabrikanten skal give det bemyndigede organ adgang til at inspicere produktions-, kontrol-, proevnings- samt oplagringsfaciliteterne og give det alle noedvendige oplysninger, herunder:

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:

- dokumentation vedroerende kvalitetssystemet

- the quality system documentation,

- kvalitetsregistreringer, herunder kontrolrapporter, proevnings- og kalibreringsdata, rapporter vedroerende personalets kvalifikationer mv.

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. Det bemyndigede organ skal gennemfoere periodiske kontrolbesoeg for at sikre sig, at fabrikanten vedligeholder og anvender kvalitetssystemet; det udsteder en kontrolrapport til fabrikanten.

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. Det bemyndigede organ kan derudover aflaegge uanmeldte besoeg hos fabrikanten. Under disse besoeg kan det foretage eller lade foretage proevninger for om noedvendigt at kontrollere, om kvalitetssystemet fungerer hensigtsmaessigt. Det udsteder en besoegsrapport og i givet fald en proevningsrapport til fabrikanten.

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. Fabrikanten skal i mindst ti aar fra datoen for ophoeret af fremstillingen af produktet kunne forelaegge de nationale myndigheder:

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:

- den i punkt 3.1, andet led, omhandlede dokumentation

- the documentation referred to in the second indent of the second subparagraph of point 3.1,

- de i punkt 3.4, andet afsnit, omhandlede meddelelser om aendringer

- the updating referred to in the second subparagraph of point 3.4,

- de i punkt 3.4, fjerde afsnit, og punkt 4.3 og 4.4 omhandlede afgoerelser og rapporter fra det bemyndigede organ.

- 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. Hvert bemyndiget organ meddeler de oevrige bemyndigede organer relevante oplysninger om udstedte eller tilbagekaldte godkendelser af kvalitetssystemer.

6. Each notified body shall give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.

BILAG X

ANNEX X

PRODUKTVERIFIKATION (modul F)

PRODUCT VERIFICATION (module F)

1. Dette modul beskriver den procedure, hvorved fabrikanten eller dennes i Faellesskabet etablerede repraesentant garanterer og erklaerer, at de produkter, som bestemmelserne i punkt 3 er blevet anvendt paa, er i overensstemmelse med den type, som er beskrevet i EF-typeafproevningsattesten, og opfylder de relevante krav i direktivet.

1. This module describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the products subject to the provisions of point 3 are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them.

2. Fabrikanten traeffer alle noedvendige foranstaltninger for, at fremstillingsprocessen sikrer, at produkterne er i overensstemmelse med den type, som er beskrevet i EF-typeafproevningsattesten og med de relevante krav i direktivet. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant anbringer CE-maerkningen paa hvert enkelt produkt og udsteder en overensstemmelseserklaering (jf. bilag XV).

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 Directive that apply to them. The manufacturer or his authorized 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. Det bemyndigede organ foretager de noedvendige undersoegelser og proevninger for at verificere, at produktet er i overensstemmelse med direktivets krav; dette kan efter fabrikantens valg foregaa enten ved kontrol og proevning af hvert enkelt produkt som beskrevet i punkt 4 eller ved kontrol og proevning af produkterne paa et statistisk grundlag som beskrevet i punkt 5.

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 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.

3.a. Fabrikanten eller dennes repraesentant opbevarer en kopi af overensstemmelseserklaeringen i mindst ti aar fra datoen for ophoeret af fremstillingen af produktet.

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 has been manufactured.

4. Verifikation ved kontrol og proevning af hvert enkelt produkt

4. Verification by examination and testing of every product

4.1. Alle produkter undersoeges enkeltvis, og der gennemfoeres de proevninger, der er omhandlet i den eller de relevante standarder, jf. artikel 5, eller tilsvarende proevninger for at verificere, at produkterne er i overensstemmelse med den type, som er beskrevet i EF-typeafproevningsattesten, og med de relevante krav i direktivet.

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 as described in the EC type-examination certificate and the requirements of the Directive that apply to them.

4.2. Det bemyndigede organ anbringer eller lader anbringe sit identifikationsnummer paa hvert enkelt godkendt produkt og udsteder en skriftlig overensstemmelsesattest vedroerende de gennemfoerte proevninger.

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. Fabrikanten eller dennes repraesentant skal paa opfordring kunne forevise den overensstemmelsesattest, der er udstedt af det bemyndigede organ.

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. Statistisk verifikation

5. Statistical verification

5.1. Fabrikanten fremlaegger sine produkter i form af ensartede partier og traeffer alle noedvendige foranstaltninger for at sikre, at fremstillingsprocessen garanterer, at alle producerede partier bliver ensartede.

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. Alle produkter skal kunne verificeres i form af ensartede partier. Der udtages en stikproeve af hvert parti. Produkterne i en proeve undersoeges enkeltvis, og der gennemfoeres de proevninger, der er omhandlet i den eller de relevante standarder, jf. artikel 5, eller tilsvarende proevninger for at verificere, om produkterne er i overensstemmelse med de relevante krav i direktivet, og for at fastslaa, om partiet skal godkendes eller kasseres.

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 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 is accepted or rejected.

5.3. Der anvendes foelgende elementer under den statistiske procedure:

5.3. The statistical procedure shall use the following elements:

- den statistiske metode, der skal anvendes

- the statistical method to be applied,

- karakteristika ved proeveudtagningen.

- the sampling plan with its operational characteristics.

5.4. For saa vidt angaar godkendte partier skal det bemyndigede organ anbringe eller lade anbringe sit identifikationsnummer paa hvert enkelt produkt og udstede en skriftlig overensstemmelsesattest vedroerende de foretagne proevninger. Alle produkter i partiet kan markedsfoeres, undtagen de produkter fra proeven, der ikke opfylder overensstemmelseskravene.

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.

Kasseres et parti, traeffer vedkommende bemyndigede organ de noedvendige foranstaltninger for at forhindre, at det paagaeldende parti markedsfoeres. Hvis der ofte maa kasseres partier, kan det bemyndigede organ stille den statistiske verifikation i bero.

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.

Fabrikanten kan under fremstillingsprocessen paa det bemyndigede organs ansvar anbringe dettes identifikationsnummer paa produktet.

The manufacturer may, under the responsibility of the notified body, affix the latter's distinguishing number during the manufacturing process.

5.5. Fabrikanten eller dennes repraesentant skal paa opfordring kunne forevise den overensstemmelsesattest, der er udstedt af det bemyndigede organ.

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.

BILAG XI

ANNEX XI

ENHEDSVERIFIKATION (modul G)

UNIT VERIFICATION (module G)

1. Dette modul beskriver den procedure, hvorved fabrikanten garanterer og erklaerer, at det paagaeldende produkt, for hvilket der er udstedt den i punkt 2 omhandlede attest, er i overensstemmelse med de krav i direktivet, der gaelder for det. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant anbringer CE-maerkningen paa produktet og udsteder en overensstemmelseserklaering (jf. bilag XV).

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, conforms to the requirements of 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. Det bemyndigede organ undersoeger produktet og gennemfoerer de proevninger, der er omhandlet i den eller de relevante standarder, jf. artikel 5, eller tilsvarende proevninger for at sikre, at det er i overensstemmelse med de relevante krav i direktivet.

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 Article 5, or equivalent tests, to ensure its conformity with the relevant requirements of the Directive.

Det bemyndigede organ anbringer eller lader anbringe sit identifikationsnummer paa det godkendte produkt og udsteder en overensstemmelsesattest vedroerende de gennemfoerte proevninger.

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. Den tekniske dokumentation skal goere det muligt at vurdere produktets overensstemmelse med direktivets krav samt forstaa dets konstruktion, fremstilling og funktion (jf. bilag XIII).

3. The aim of the technical documentation is to 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).

BILAG XII

ANNEX XII

FULD KVALITETSSIKRING (modul H)

FULL QUALITY ASSURANCE (module H)

1. Dette modul beskriver den procedure, hvorved en fabrikant, der opfylder bestemmelserne i punkt 2, garanterer og erklaerer, at de paagaeldende produkter opfylder de krav i direktivet, der gaelder for dem. Fabrikanten eller dennes i Faellesskabet etablerede repraesentant anbringer CE-maerkningen paa hvert enkelt produkt og udsteder en skriftlig overensstemmelseserklaering (jf. bilag XV). Sammen med CE-maerkningen anfoeres det identifikationsnummer, der anvendes af det bemyndigede organ, som er ansvarligt for den i punkt 4 omhandlede kontrol.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 2 ensures and declares that 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 responsible for the surveillance as specified in point 4.

2. Fabrikanten anvender et godkendt kvalitetssystem for konstruktion, fremstilling, endelig produktkontrol og proevning som beskrevet i punkt 3 og er underlagt den i punkt 4 omhandlede kontrol.

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. Kvalitetssystem

3. Quality system

3.1. Fabrikanten indsender en ansoegning om vurdering af kvalitetssystemet til et bemyndiget organ efter eget valg.

3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body.

Ansoegningen skal indeholde:

The application shall include:

- alle relevante oplysninger vedroerende den planlagte produktkategori

- all relevant information for the product cagetory envisaged,

- dokumentation vedroerende kvalitetssystemet.

- the quality system's documentation.

3.2. Kvalitetssystemet skal sikre, at produkterne opfylder de relevante krav i direktivet.

3.2. The quality system shall ensure compliance of the products with the requirements of the Directive that apply to them.

Alle de forhold, krav og bestemmelser, som fabrikanten har taget hensyn til, skal dokumenteres paa systematisk og overskuelig maade i en skriftlig redegoerelse for forholdsregler, procedurer og instruktioner. Denne dokumentation vedroerende kvalitetssystemet skal sikre, at kvalitetsprogrammer, -planer, -manualer og -registre fortolkes ens.

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.

Redegoerelsen skal bl.a. indeholde en fyldestgoerende beskrivelse af:

It shall contain in particular an adequate description of:

- kvalitetsmaalsaetninger og organisationsstruktur samt ledelsens ansvar og befoejelser med hensyn til konstruktions- og produktkvalitet

- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to design and product quality,

- de tekniske konstruktions specifikationer, herunder standarder, der vil blive anvendt, samt, hvis de i artikel 5 omhandlede standarder ikke anvendes fuldt ud, hvordan det sikres, at de vaesentlige krav i direktivet, der gaelder for produkterne, vil blive opfyldt

- 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 requirements of the Directive that apply to the products will be met,

- de teknikker til konstruktionskontrol og -verifikation samt de processer og systematiske foranstaltninger, der vil blive anvendt ved konstruktionen af produkterne, for saa vidt angaar den paagaeldende produktkategori

- 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,

- de tilsvarende teknikker for fremstilling, kvalitetskontrol og kvalitetssikring samt de systematiske fremgangsmaader og foranstaltninger, der vil blive anvendt

- the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

- de undersoegelser og proevninger, der skal udfoeres foer, under og efter produktionen, og den hyppighed, hvormed dette sker

- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

- kvalitetsregistreringer, herunder kontrolrapporter samt proevnings- og kalibreringsdata, rapporter vedroerende personalets kvalifikationer mv.

- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

- metoderne til verifikation af, at den kraevede konstruktions- og produktkvalitet er opnaaet, og at kvalitetssystemet fungerer effektivt.

- the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.

3.3. Det bemyndigede organ vurderer kvalitetssystemet for at fastslaa, om det opfylder kravene i punkt 3.2. Organet skal antage, at disse krav er opfyldt i forbindelse med kvalitetssystemer, hvor den harmoniserede standard paa omraadet (EN 29001) er anvendt.

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 compliance with these requirements in respect of quality systems that implement the relevant harmonized standard (EN 29001).

Kontrolholdet skal mindst omfatte ét medlem, som har erfaring med at vurdere den paagaeldende produktteknologi. Vurderingsproceduren skal omfatte et besoeg paa fabrikantens anlaeg.

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.

Afgoerelsen skal meddeles fabrikanten. Meddelelsen skal indeholde resultaterne af undersoegelsen og den begrundede vurderingsafgoerelse.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. Fabrikanten forpligter sig til at opfylde sine forpligtelser i henhold til kvalitetssystemet, saaledes som det er godkendt, og til at vedligeholde det, saaledes at det forbliver hensigtsmaessigt og effektivt.

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.

Fabrikanten eller dennes repraesentant underretter det bemyndigede organ, som har godkendt kvalitetssystemet, om enhver paataenkt aendring af kvalitetssystemet.

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.

Det bemyndigede organ vurderer de foreslaaede aenderinger og afgoer, om det aendrede kvalitetssystem stadig opfylder de i punkt 3.2 omhandlede krav, eller om en fornyet vurdering er noedvendig.

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.

Det bemyndigede organ meddeler fabrikanten sin afgoerelse. Meddelelsen skal indeholde resultaterne af undersoegelsen og den begrundede vurderingsafgoerelse.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. EF-kontrol paa det bemyndigede organs ansvar

4. EC surveillance under the responsibility of the notified body

4.1. Formaalet med kontrollen er at sikre, at fabrikanten fuldt ud opfylder sine forpligtelser i henhold til det godkendte kvalitetssystem.

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. Fabrikanten skal give det bemyndigede organ adgang til at kontrollere konstruktions-, fremstillings-, kontrol-, proevnings- og oplagringsfaciliteterne og skal give det alle noedvendige oplysninger, herunder:

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:

- dokumentation vedroerende kvalitetssystemet

- the quality system documentation,

- kvalitetsregistreringer i henhold til konstruktionsdelen i kvalitetssystemet saasom resultater af analyser, beregninger, proevninger mv.

- the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

- kvalitetsregistreringer i henhold til produktionsdelen i kvalitetssystemet, saasom kontrolrapporter samt proevnings- og kalibreringsdata, rapporter over personalets kvalifikationer mv.

- 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. Det bemyndigede organ skal gennemfoere periodiske kontrolbesoeg for at sikre sig, at fabrikanten vedligeholder og anvender kvalitetssystemet, og skal udarbejde en kontrolrapport til fabrikanten.

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. Det bemyndigede organ kan derudover aflaegge uanmeldte besoeg hos fabrikanten. Under disse besoeg kan det bemyndigede organ foretage eller lade foretage proevninger for om noedvendigt at kontrollere, om kvalitetssystemet fungerer effektivt. Det udsteder en besoegsrapport og i givet fald en proevningsrapport til fabrikanten.

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. Fabrikanten skal i mindst ti aar fra datoen for ophoeret af fremstillingen af produktet kunne forelaegge de nationale myndigheder:

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:

- den i punkt 3.1, andet afsnit, tredje led, omhandlede dokumentation

- the documentation referred to in the second indent of the second subparagraph of point 3.1,

- de i punkt 3.4, andet afsnit, omhandlede meddelelser om aendringer

- the updating referred to in the second subparagraph of point 3.4,

- de i punkt 3.4, sidste afsnit, og i punkt 4.3 og 4.4 omhandlede afgoerelser og rapporter fra det bemyndigede organ.

- 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. Det enkelte bemyndigede organ meddeler de oevrige bemyndigede organer relevante oplysninger om udstedte eller tilbagekaldte godkendelser af kvalitetssystemer.

6. Each notified body shall forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.

BILAG XIII

ANNEX XIII

TEKNISK DOKUMENTATION FREMLAGT AF FABRIKANTEN

TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER

Den tekniske dokumentation, der er omhandlet i bilag V, VII, VIII, IX og XI, skal omfatte alle relevante data og midler, som fabrikanten benytter til at sikre, at fartoejer og komponenter dertil opfylder de vaesentlige krav, der gaelder for dem.

The technical documentation referred to in Annexes V, 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.

Den tekniske dokumentation skal goere det muligt at forstaa produktets konstruktion, fremstilling og funktion samt at vurder, dets overensstemmelse med direktivets krav.

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 this Directive.

Dokumentationen skal indeholde foelgende oplysninger, for saa vidt de er relevante for vurderingen:

The documentation shall contain so far as relevant for assessment:

- en almindelig beskrivelse af typen

- a general description of the type,

- konstruktions- og fabrikationstegninger samt skitser af komponenter, delmontager, kredsloeb osv.

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- de noedvendige beskrivelser og forklaringer til forstaaelse af ovennaevnte tegninger og skitser samt af produktets funktion

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- en liste over de standarder, der er naevnt i artikel 5, og som helt eller delvis er anvendt, samt en beskrivelse af de loesninger, der er valgt med henblik paa at opfylde de vaesentlige krav i de tilfaelde, hvor de i artikel 5 naevnte standarder ikke er anvendt

- 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,

- resultater af konstruktionsberegninger og undersoegelser mv.

- results of design calculations made, examinations carried out, etc.,

- proevningsrapporter eller beregninger af stabilitet efter bilag I, punkt 3.2, i de vaesentlige krav og af flydeevne efter bilag I, punkt 3.3, i de vaesentlige krav.

- 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.

BILAG XIV

ANNEX XIV

MINIMUMSKRITERIER, SOM MEDLEMSSTATERNE SKAL IAGTTAGE VED BEMYNDIGELSE AF ORGANERNE

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF BODIES

1. Organet, dets leder og det personale, der skal udfoere verifikationsarbejdet, maa hverken have konstrueret, vaere fabrikant eller leverandoer af eller vaere beskaeftiget med montage af de fartoejer og komponenter dertil, som de kontrollerer, eller vaere nogen af de naevnte personers repraesentant. De maa hverken deltage direkte eller som repraesentant i konstruktion, fremstilling, markedsfoering eller vedligeholdelse af disse komponenter eller fartoejer. Dette udelukker ikke, at der kan udveksles tekniske oplysninger mellem fabrikant og organ.

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. Organet og det personale, der skal udfoere kontrollen, skal udfoere kontrolarbejdet med den stoerst mulige faglige uafhaengighed og den stoerste tekniske kompetence samt vaere uafhaengig af enhver form for pression og incitament, navnlig af finansiel art, som kan paavirke deres bedoemmelse eller resultaterne af deres kontrol, isaer fra personer eller grupper af personer, der har interesse i verifikationsresultaterne.

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. Organet skal raade over det noedvendige personale og besidde de noedvendige midler for paa fyldestgoerende maade at udfoere de tekniske og administrative opgaver i forbindelse med gennemfoerelsen af verifikationen; det skal ligeledes have adgang til det noedvendige materiel for at kunne foretage saerkontrol.

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. Det personale, som skal udfoere kontrollen, skal have:

4. The staff responsible for inspection shall have:

- en god teknisk og faglig uddannelse

- sound technical and professional training,

- et tilstraekkeligt kendskab til forskrifterne vedroerende den kontrol, det udfoerer, og tilstraekkelig praktisk erfaring med hensyn til et saadant kontrolarbejde

- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

- den noedvendige faerdighed i at udarbejde de attester, journaler og rapporter, som gengiver resultaterne af den udfoerte kontrol.

- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5. Det personale, som skal udfoere kontrollen, skal sikres fuld uafhaengighed. Afloenningen af hver enkelt ansat maa hverken vaere afhaengig af det antal kontrolfunktioner, den paagaeldende udfoerer, eller af resultaterne af denne kontrol.

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. Organet skal vaere ansvarsforsikret, medmindre det civilretlige ansvar daekkes af staten paa grundlag af nationale retsregler, eller kontrollen udfoeres direkte af medlemsstaterne.

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. Organets ansatte er underlagt tavshedspligt om alt, hvad de faar kendskab til under udfoerelsen af arbejdet (undtagen over for de kompetente administrative myndigheder i den stat, hvor de udfoerer deres arbejde) i henhold til dette direktiv eller enhver national retsforskrift, der er udstedt i medfoer af dette.

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 Directive or any provision of national law giving effect to it.

BILAG XV

ANNEX XV

SKRIFTLIG OVERENSSTEMMELSESERKLAERING

WRITTEN DECLARATION OF CONFORMITY

1. Den skriftlige erklaering om overensstemmelse med direktivets bestemmelser skal altid ledsage:

1. The written declaration of conformity to the provisions of the Directive must always accompany:

- fritidsfartoejet og indgaa i ejerens instruktionsbog (bilag I, punkt 2.5)

- the recreational craft and be joined to the owner's manual (Annex I, point 2.5),

- de i bilag II omhandlede komponenter.

- the components as referred to in Annex II.

2. Den skriftlige overensstemmelseserklaering skal indeholde foelgende (1):

2. The written declaration of conformity shall include the following (1):

- navn og adresse paa fabrikanten eller dennes i Faellesskabet etablerede repraesentant (2)

- name and address of the manufacturer or his authorized representative established in the Community (2),

- en beskrivelse af fritidsfartoejet (3) eller komponenten dertil (3)

- description of the recreational craft (3) or of the component (3),

- henvisninger til de relevante harmoniserede standarder, der er anvendt, eller henvisninger til de specifikationer i henhold til hvilke overensstemmelsen er erklaeret

- references to the relevant harmonized standards used, or references to the specifications in relation to which conformity is declared,

- hvor det er aktuelt, henvisning til den af et bemyndiget organ udstedte EF-typeafproevningsattest

- where appropriate, reference to the EC type-examination certificate issued by a notified body,

- hvor det er aktuelt, navn og adresse paa det bemyndigede organ

- where appropriate, the name and address of the notified body,

- identifikation af den befuldmaegtigede person, der kan underskrive paa vegne af fabrikanten eller dennes i Faellesskabet etablerede repraesentant.

- identification of the person empowered to sign on behalf of the manufacturer or his authorized representative established within the Community.

(1) og vaere affattet paa det eller de sprog, der er omhandlet i bilag I, punkt 2.5.

(1) and be drawn up in the language(s) as foreseen under point 2.5 of Annex I.

(2) Firmanavn, fuldstaendig adresse; anfoeres repraesentantens navn og adresse, skal ogsaa fabrikantens firmanavn og adresse anfoeres.

(2) business name and full address; authorized representative must also give the business name and address of the manufacturer.

(3) Beskrivelse af det paagaeldende produkt: maerke, type, serienummer (eventuelt).

(3) description of the product make, type, serial number, where appropriate.