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The authorized representative established in the Community may or may not be in possession of the technical file.
Det hænder, at brugere benytter sig af små vedligeholdelsesvirksomheder, der ikke altid har varige forbindelser med fabrikanten, og som udskifter slidte dele med dele, der ligner, men ikke er identiske med de dele, som fabrikanten anbefaler i instruktio
However, a person who places machinery or a safety component on the market but who is neither the manufacturer nor his authorized representative established in the Community must have the file at his disposal or, at least, have formal assurances in writing from the manufacturer that the file will be made available in response to a substantiated request.
Dette punkt vil blive behandlet mere detaljeret ved gennem gangen af bilag V.
This paragraph concerns the particular form of the EC declaration of conformity for safety
Medlemsstaterne anser - maskiner, der er forsynet med EF-mærkning, og som ledsages af den i bilag II, afsnit A, omhandlede EF-overensstemmelseserklæring - sikkerhedskomponenter, som ledsages af den i bilag II, afsnit C, omhandlede EF-overensstemmelseserklæring for at opfylde samtlige bestemmelser i dette direktiv, herunder de procedurer for overensstemmelsesvurdering, der er fastsat i kapitel II.
Member States shall regard the following as conforming to all the provisions of this Directive, including the procedures for checking the conformity provided for in Chapter II:
Såfremt der ikke findes harmoniserede standarder, fastsætter medlemsstaterne de bestemmelser, som de finder nødvendige for, at de berørte parter får kendskab til de gældende nationale standarder og tekniske specifikationer, der betragtes som vigtige eller nyttige dokumenter i forbindelse med korrekt anvendelse af de væsentlige sikkerheds- og sundhedskrav i bilag I.
In the absence of harmonized standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential safety and health requirements in Annex I.
lighed (ydeevne), beregningsmetoder og prøvningsmetode osv.
governed by private law and are useful in con tracts but are not compulsory — is the subject of much comment in the literature concerning the 'public procurement' Directives, and must be analysed with discernment.
Der skelnes i direktivet underforstået mellem forskellige typer af standarder: — Harmoniserede standarder: Under gen nemgangen af betragtningerne har vi set, at dette er standarder, som er udarbejdet af CEN eller CENELEC efter mandat fra Kommissionen,
In the absence of harmonized European stan dards, national standards or specifications (e.g. the UVV specifications of the Berufsgenossenschaften and the technical parts of national regulations) can be used, provided the Member States in which they apply have brought the importance which they attach to them to the attention of all the parties concerned. What is the point of this clause?
— Europæiske standarder: Standarder som CEN eller CENELEC har udarbejdet for at imødekomme industriens eller handelens behov.
The Directive implicitly differentiates between several types of standard: (i) harmonized standards: as we saw in the re citals, these are standards established by CEN or Cenelec on the basis of a remit from the Com mission; (ii) European standards: these are standards established by CEN or Cenelec to meet industrial or commercial requirements.
Alle nationale standarder, der behandler samme emne, skal trækkes tilbage og erstattes med en oversættelse afden tilsvarende europæiske standard.
Any national standard dealing with the same subject must be withdrawn and replaced by the transcription of the European standard; (iii) national standards.
De giver i mange tilfælde mulighed for loyal kon kurrence, hvilket er baggrunden for, at de gøres obligatoriske i direktiver om offentlige indkøbsog anlægskontrakter.
Although other means may be available for demonstrating compliance, the standard has the advantage of setting a safety level: even if the manufacturer does not follow the standard, at least he has an idea of the level of safety to be attained.
De kan danne grundlag for kvalitetsmærker. De findes både på de harmoniserede og på de ikke-harmoniserede områder.
In the absence of harmonized standards or European standards, he is forced to seek this idea elsewhere.
Forpligtelsen til at benytte de europæiske standarder ved offentlige indkøbs- og anlægskontrakter, synes at stride imod den omstændighed (som Rådet bekræftede i en resolution den 17.5.1985), at standarder i alle lande er privatretlige dokumenter, som er nyttige i forbindelse med kontrakter, men ikke obligatoriske.
European standards cover various traditional areas of standardization: characteristics not covered by a 'new approach' Directive (environmental impact, etc.), dimensional interchangeability, functional interchangeability (performance), design methods, test methods, etc.
Denne forpligtelse har der været skrevet meget om i litteraturen om direktiverne om offentlige indkøbs- og anlægskontrakter.
In many cases they make fair trading possible, and this is why the 'public procurement' Directives make them compulsory. They can also serve as the basis for quality marks.
Den skal analyseres omhyggeligt og med stor skønsomhed.
They exist in both harmonized and unharmonized areas.
De harmoniserede standarders rolle forklares nærmere i kommentarerne til stykke 2.
To manufacture a good product it is important to be aware of these standards.
De europæiske standarder skal bruges på de sædvanlige standardiseringsområder: egenskaber, som ikke er behandlet i et direktiv efter den »nye metode« (f.eks. påvirkning af miljøet), dimensionei udskiftelighed, funktionel udskifte
The obligation to use European standards for the purposes of public procurement — in apparent contradiction to the fact, reaffirmed by the Council resolution of 7 May 1985 that, in all countries, standards are
Hvis der ikke foreligger harmoniserede europæiske standarder, så kan de nationale standarder eller specifikationer (f.eks.
The Directive does not specify the means to be used, so the Member States have complete liberty to decide for themselves.
Artiklerne hvilken betydning disse standarder eller specifikationer tillægges.
Corpus of the Machinery Directive
Når en national standard, der gennemfører en harmoniseret standard, hvis reference er blevet offentliggjort i De Europæiske Fællesskabers Tidende, omfatter et eller flere væsentlige sikkerhedskrav, forudsættes den maskine eller sikkerhedskomponent, der er fremstillet i overensstemmelse med denne standard, at være I overensstemmelse med de pågældende væsentlige krav.
Where a national standard transposing a harmonized standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential safety requirements, machinery or safety components con­structed in accordance with this standard shall be presumed to comply with the relevant essential requirements.
Medlemsstaterne offentliggør referencerne for de nationale standarder, der gennemfører de harmoniserede standarder.
Member States shall publish the references of national standards transposing har­monized standards.
— C-standarder er såkaldte vertikale standarder, der handler om en type maskine.
Harmonized standards confer the presumption of compliance with the essential requirements which they cover.
De harmoniserede standarder giver formodning om overensstemmelse med de væsentlige krav, som de handler om.
However, in this case he must clear­ly attain a level of safety at least equivalent to that established by the harmonized standards.
Ligesom alle andre standarder er de ikke obligatoriske og fabrikanten kan altid benytte andre midler til at opfylde de væsentlige krav.
Har­monized standards fix the 'state of the art' at a given moment and, accordingly, the level of safety which is attainable at the time of drafting.
Men det er klart, at han i så fald skal have nået et sikkerhedsniveau, som i det mindste svarer til det, som er fastlagt af de pågældende harmoniserede standarder.
For example, if a harmonized standard prescribes a value for a safety coefficient to be used in a calculation, designers must either use this value or explain in the technical file the rea­sons which permit them to use another value while ensuring an equivalent level of safety, for example by taking complementary measures.
De harmoniserede standarder afspejler nemlig »teknikkens stade« på et givet tidspunkt og dermed det sikkerhedsniveau, som kan nås, på det tidspunkt, hvor de udarbejdes.
If we take the example of the Bl standard defining various types of locking device — with one detec­tor, with two detectors, with two detectors and er­ror checking, etc. — we can understand this doubt.
Hvis den harmoniserede standard f.eks. foreskriver en bestemt værdi for en sikkerhedskoefficient, som skal benyttes i en beregning, skal konstruktørerne enten benytte denne værdi eller forklare i det tekniske dossier, hvad det er, der gør det muligt for dem at benytte en anden, uden at det går ud over sikkerhedsniveauet.
However, if we apply this Bl standard in conjunction with another Bl standard, that relat­ing to risk evaluation, we can say that the simul­taneous application of the two standards can con­fer the presumption of conformity with require­ments 1.3.7 and 1.3.8.
Har fabrikanten valgt at følge en eller flere har moniserede standarder for at opfylde de væsentlige sikkerheds- og sundhedskrav, som disse standarder handler om, så har han truffet de foranstaltninger, der kan kræves af ham.
Where a manufacturer has chosen to follow one or more harmonized standards in order to satisfy the essential health and safety requirements which they cover, he has taken the measures which can be expected of him.
Hvis en medlemsstat bestrider gyldigheden af den såle des valgte løsning, skal den benytte sig af sikker hedsklausulen (artikel 7) over fór standardiseringsorganisationerne, og ikke over for fabrikanten.
If a Member State disputes the solution he has adopted, it must apply the safeguard clause (Article 7) vís­â­vjsthe stan­dards authorities and not vis-à-vis the manufac­turer.
Ved at anvende de harmoniserede standarders løsninger bringer fabrikanten sig ganske vist ikke helt i ly for en eventuel anvendelse af sikkerhedsklausulen, men han sikrer sig alligevel i væsentlig grad.
Application of the solutions laid down in the harmonized standards does not fully protect the manufacturer from the possibility of the safe­guard clause being applied, but it does provide a very important degree of 'relative certainty'.
Mens man uden problemer kan forstå, hvad det vil sige at opfylde en C-standard, og hvordan opfyldelse af en C-standard kan give formodning om overensstemmelse med de væsendige krav, som standarden behandler, så er der usikkerhed på, hvordan man opfylder visse B-standarder.
Article 5(1) states that ma­chinery bearing the CE mark shall be regarded as conforming to the Directive, whereas Article 5(2) states that machinery conforming to har­monized standards shall be presumed to comply with the essential requirements covered by those standards.
Hvis vi som eksempel tager en Bl-standard, der fasdægger forskellige låseanordninger — med en detektor, med to detektorer, med to detektorer og selvovervågning osv. — så bliver ovennævnte usikkerhed forståelig.
Armed with this presumption, the manufacturer will obviously affix the CE mark and the machinery will then be covered by Article 5 (1), but the use of the two different terms remains.
Men benytter man denne Bl-standard sammen med en anden Bl-standard, nemlig den der handler om risikovurdering, kan man sige, at samtidig anvendelse af de to standarder kan give for modning om overensstemmelse med kravene i 1.3.7 og 1.3.8.
Where the relevant standardization committee has not transposed the standard, use of the origi­nal harmonized standard or of a transposed stan­dard in another Member State confers the same presumption of conformity.
Kommissionens tjenestegrene mener, at Bl- og B2-standarderne er de nyttigste for anvendelsen af direktivet, og de lægger vægt på, at disse stan darder bevares som harmoniserede standarder.
However, such transposition must have taken place into the nat­ional standards collection of at least one of the Member States of the European Community.
I stk. 3 opfordres medlemsstaterne til at sørge for, at alle arbejdsmarkedets parter inddrages i standardiseringsarbejdet.
This paragraph calls on the Member States to en sure that all the social partners are associated with the standardization process.
Denne bestemmelse er navnlig taget med for at undgå, at lønmodtagernes repræsentanter glemmes, hvad de som oftest bliver i denne forbindelse.
The main purpose is to ensure that workers' representa tives are not forgotten, as they are generally left out.
Såfremt en medlemsstat eller Kommissionen finder, at de i artikel 5, stk. 2, omhand lede harmoniserede standarder ikke fuldstændigt opfylder de væsentlige krav, der vedrører dem, og som er omhandlet i artikel 3 , indbringer Kommissionen eller medlemsstaten sagen for det udvalg, der er nedsat ved direktiv 83/189/EØF, og redegør for årsagerne hertil.
Where a Member State or the Commission considers that the harmonized standards referred to in Article 5(2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the committee set up under Directive 83/189/EEC, giving the reasons therefor.
Udvalget afgiver en hasteudtalelse.
The com mittee shall deliver an opinion without delay.
På baggrund af udvalgets udtalelse underretter Kommissionen medlemsstaterne om, hvorvidt det er nødvendigt at tilbagetrække berørte standarder i de i artikel 5, stk. 2, omhandlede offentliggørelser.
Upon receipt of the committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published in formation referred to in Article 5(2).
Der nedsættes et stående udvalg sammensat af repræsentanter, udpeget af med lemsstaterne og med en repræsentant for Kommissionen som formand.
A standing committee shall be set up, consisting of representatives appointed by the Member States and chaired by a representative of the Commission.
Det stående udvalg fastsætter sin forretningsorden.
The standing committee shall draw up its own rules of procedure.
Det stående udvalg kan forelægges ethvert spørgsmål i forbindelse med iværksættelsen og den praktiske gennemførelse af direktivet efter følgende fremgangsmåde:
Any matter relating to the implementation and practical application of this Directive may be brought before the standing committee, in accordance with the following procedure.
Udvalget afgiver en udtalelse om dette udkast inden for en frist, som for manden kan fastsætte under hensyntagen til de pågældende spørgsmåls hastende karakter, i givet fald ved afstemning.
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.
Her præsenteres de to udvalg, som skal forvalte problemerne med at anvende direktivet.
Paragraph 1 refers to the standing committee set up under Council Directive 83/189/EEC.
tilkendegive over for CEN eller CENELEC, at et mandat ikke er blevet opfyldt, hvis det finder, at en standard ikke opfylder de væsentlige krav (se også artikel 7).
Article 7
Med stk. 2 oprettes der et rådgivende udvalg. Det har til opgave at udtale sig over for Kommissionen om de uklarheder ved et væsentligt krav,
- safety components accompanied by the EC declaration of conformity, used in accordance with their intended purpose are liable to endanger the safety of persons, and, where
Artiklerne som kan vise sig i den praktiske anvendelse. Selv om Kommissionen ikke er bundet af udvalgets udtalelse, skal Kommissionen tage »størst muligt hensyn« til den.
The Member State shall immediately inform the Commission of any such measure, in dicating the reasons for its decision and, in particular, whether non-conformity is due to: (a) failure to satisfy the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5(2); (c) shortcomings in the standards referred to in Article 5(2) themselves.
Hverken dette udvalg eller Kommissionen har beføjelser til at fortolke direktivets artikler eller de væsentlige sikkerheds- og sundhedskrav. Det
This is the safeguard clause; it enables the Member States to adopt measures in spite of Article 4(1) where such measures are warranted.
Medlemsstaten underretter straks Kommissionen om denne foranstaltning og anfører grundene til beslutningen, herunder navnlig om den manglende overensstemmelse skyldes: a) at de i artikel 3 omhandlede væsentlige krav ikke er opfyldt b) fejlagtig anvendelse af de i artikel 5, stk. 2, omhandlede standarder c) en mangel ved selve de i artikel 5, stk. 2, omhandlede standarder.
A Member State which voted against a standard which was accepted by the majority cannot invoke the safeguard clause on the grounds of what it considers to be a shortcoming in that standard and thereby reopen a debate which has been closed. This point refers instead to essential requirements which the standardization authorities, acting in good faith, have neglected to cover.
Her har vi sikkerhedsklausulen, som giver med lemsstaterne mulighed for at træffe foranstaltninger på trods af artikel 4, stk. 1, når det er berettiget.
Paragraph 1 restricts arbitrary action by the Member States by requiring the party invoking the safeguard clause to state the grounds on which its action is based.
I denne artikel har medlemsstaterne et middel til at drage fabrikantens påstande i tvivl og kuldkaste den formodning om overensstem melse, som maskinerne nyder godt af, når de er forsynet med EF-mærket og anvendes til det for mål, som fabrikanten anser for det normale.
It is not sufficient simply to refer to one of the three possibilities given in points (a), (b) and (c), but the grounds given must be classified in one of these three categories so that the Commission can examine the case and the manufacturer can, where appropriate, de fend his rights.
Litra b)-begrundelser (fejlagtig anvendelse af standarder) berører kun de tilfælde, hvor fabri kanten forpligter sig til at overholde standarderne.
The grounds referred to in point (a) require no further clarification.
I ingen andre tilfælde er litra b) relevant, eftersom standarder anvendes på frivilligt grundlag.
However, what is meant by the grounds referred to in points (b) and (c)?
Artikel 7 finder altså ikke anvendelse på maski ner uden EF-mærke eller maskiner, der ikke anvendes i overensstemmelse med deres bestemmelse.
Incorrect application of the standards (point (b)) only concerns cases where the manufacturer un-
Litra c)-begrundelser skal benyttes med forsigtighed.
In practical terms, as soon as the hazard to the health and/or safety of persons has been recognized, the Member State takes appropriate measures.
En medlemsstat, som har stemt mod en stan dard, der i øvrigt er accepteret af flertallet, kan ikke påkalde sig den såkaldte mangel ved denne standard som begrundelse for at benytte sikker hedsklausulen og på den måde tage en en gang afsluttet diskussion op igen.
These measures must be proportionate to the danger, i.e. not necessarily an immediate comprehensive ban, and the grounds must be stated.
Stk. 1 begrænser eventuelle vilkårligheder fra medlemsstaternes side ved at kræve, at indgreb på grundlag af sikkerhedsklausulen skal begrundes.
Such measures do not re quire prior authorization from the Commission, but the Commission must be informed immediately. mediately.
I praksis træffer medlemsstaten de fornødne foranstaltninger, så snart det er konstateret, at der er risiko for personers (osv. ) sundhed og/eller sikkerhed.
Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States.
Foranstaltningerne skal dels stå i et rimeligt forhold til faren, hvilket vil sige, at der ikke nødvendigvis er tale om omgående og totale for bud, dels begrundes.
Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community.
Foranstaltningerne må ikke tage form af en definitiv sanktion, men skal være en almen foranstaltning, der har til formål at be skytte brugerne, og som ikke foregriber spørgsmå-
Where the decision referred to in paragraph 1 is based on a shortcoming in the standards, and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the committee in order to initiate the procedures referred to in Article 6(1).
Begrundelseskategorien under litra a) kræver ingen uddybning.
Paragraph 2 indicates what happens next.
Men hvad ligger der i de kategorier af begrundelser, som anføres under litra b) og c)?
He should take appropriate legal advice, collect as much documentation on the
kanter og brugere; lønmodtagernes fagforeninger; kontrolorganerne osv. Fabrikanten eller den nes repræsentant har interesse i at følge Kommissionens arbejde skridt for skridt, afholde sine egne høringer og stille forslag.
The number of parties de­pends on the seriousness of the problem: the authorities responsible for supervising the manufacturer, if they did not invoke the safe­guard clause, the manufacturer or his authorized representative, the manufacturers' trade organ­izations, users, trade unions, control bodies, etc.
Stk. 2 angiver, hvad der videre sker.
It is in the interest of the manufacturer or his
Når først Kommissionen har afgjort, om foranstaltningen er berettiget, er det ved at være temmelig sent for fabrikanten at sætte sit forsvar i gang.
Once the Commission has decided that the measure is justified, it is rather late for the manufacturer to defend himself.
Han kan stadig gå domstolsvejen, men så varer det meget længe, før der kommer praktiske resultater, og normalt får retssager ikke opsættende virkning for de trufne foranstaltninger.
He may still ap­peal to the courts, but court proceedings tend to be very slow to produce practical results and the measures taken are not generally suspended pending the outcome.
Når - en maskine, der ikke er i overensstemmelse, er forsynet med EF-mærkning - en sikkerhådskomponent, der ikke er i overensstemmelse, ledsages af en EF-overens-stemmelseserklæring træffer den kompetente medlemsstat de nødvendige foranstaltninger over for dem, der har foretaget mærkningen eller udarbejdet erklæringen, og underretter Kommissionen og de øvrige medlemsstater herom.
Where - machinery which does not comply bears the CE mark, - a safety component which does not comply is accompanied by an EC declaration of conformity, the competent Member State shall take appropriate action against whomsoever has af­fixed the mark or drawn up the declaration and shall so inform the Commission and the other Member States.
Stk. 3 fastslår medlemsstaternes forpligtelse til at gribe ind over for den, der har påsat mærket, men medlemsstaterne står frit med hensyn til, hvordan der skal gribes ind.
Article 7 (3) refers to the Member States' obliga­tion to take appropriate action against whom­soever has affixed the mark, but leaves the choice of measures to each Member State.
Situationen, hvor dette stykke skal anvendes, indtræder først, efter at procedurerne i henhold til stk. 2 er gennemført, og efter at Kommissionen har erklæret foranstaltningen for berettiget.
This paragraph is applied only after the end of the procedures referred to in Article 7 (2) and after the Commission has declared the measure to be justified.
Kommissionen sørger for, at medlemsstaterne holdes underrettet om denne procedures forløb og resultater.
The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.