natgillin/translations-raw huggingface dataset:
Det fremgår tværtimod, at fællesskabsinstitutionernemed rimelighed kunne være af den opfattelse, at der forelå alvorlige betænkeligheder for menneskers sundhed efter betydningen i artikel 3a, litra e), i direktiv 70/524, der begrundede, at zinkbacitracin som et antibiotikum med en dobbelt anvendelse både som tilsætningsstof til foderstoffer og som humanmedicinsk lægemiddel burde forbeholdes til medicinsk brug.
It submits that that provision merely authorises the Kingdom of Sweden to maintain in force for a transitional period its national legislation banning the use of antibiotics as growth promoters and does not confer power on the Council to impose such a ban at Community level.
Denne konklusion underbygges endvidere af den omstændighed, at fællesska bs ins t i tu t ionerne,som derved handlede i overensstemmelse med deres generelle politik vedrørende anvendelsen af antibiotika som tilsætningsstoffer til foderstoffer, besluttede ikke at tilbagekalde tilladelserne for antibiotika, som på tidspunktet for vedtagelsen af den anfægtede forordning ikke blev anvendt inden for humanmedicin, og som ikke var kendt for at selektere krydsresistens over for antibiotika, der anvendes i humanmedicin.
Second, Alpharma submits that, even if Article 151 of the Act of Accession, in conjunction with point El(4) of Title VII of Annex XV thereto, could serve as the legal basis for the contested regulation, that legal basis was not sufficiently precise as regards the procedure to be followed in adopting that regulation.
For så vidt angår spørgsmålet om, hvorvidt fællesskabsinstitutionerne korrekt kunne gennemføre en videnskabelig evaluering af de risici, der er forbundet med brugen af zinkbacit racinsom tilsætningsstof til foderstoffer, uden at råde over en videnskabelig udtalelse fra SCAN vedrørende dette brug af det nævnte produkt og uden at have afventet den videnskabelige rapport fra VSK, skal følgende
The Court finds that it follows from the preamble thereto that the contested regulation was adopted on the basis of Article 151 of the Act of Accession in conjunction with point El (4) of Title VII of Annex XV to the Act of Accession, and of Article 11(3) of Directive 70/524. As regards bacitracin zinc, it is common ground between the parties that, since no safeguard measures had been taken in respect of that product, the contested regulation cannot
Hvad særlig angår zinkbacitracin kunne fællesskabsinstitutionerne uden at råde over en videnskabelig udtalelse, som specifikt vedrørte dette produkt, med rette konstatere, at der på tidspunktet for vedtagelsen af den anfægtede forordning var gennemført meget begrænset
In the present case, the second subparagraph of point El (4) of Title VII of Annex XV to the Act of Accession provides that a decision on a request for adaptation of the Community legislation presented by the Swedish authorities is to be taken 'in accordance with the procedure laid down in Article 7 of Directive 70/524/EEC'.
Under henvisning til det anførte i det hele må det konkluderes, at Alpharma ikke har været i stand til at bevise, at fællesskabsinstitutionerne har begået fejl i forbindelse med risikovurderingen.
It follows from recital 35 to the contested regulation, when read in context, that when withdrawing the authorisation of bacitracin zinc the Community authorities applied the procedure laid down in Article 23 of Directive 70/524.
tilsidesættelse af
It follows that the procedure laid down in Article 23 of Directive 70/524 was followed in this case.
III — Spørgsmålet om proportionalitetsprincippet
II — Manifest errors of assessment in the risk assessment
Alpharma gør gældende, at den anfægtede forordning er blevet vedtaget under tilsidesættelse af proportionalitetsprincippet, for så vidt som denne retsakt er en foranstaltning, der er åbenbart uegnet med henblik på virkeliggørelsen af det forfulgte mål, og at fællesskabsinstitutionerne, som havde et valg mellem flere foranstaltninger,dog ikke valgte den mindst indgribende af disse.
It follows that neither Alpharma nor the Court is left uncertain as to the procedure to be followed in order to withdraw the authorisation of bacitracin zinc. That conclusion is also confirmed by Alpharma's own arguments, in particular those relating to the allegedly illegal combination of legal bases in so far as, in that context, Alpharma seeks to establish that the Community institutions did not properly follow the procedure laid down in Article 23 of Directive 70/524.
Det følger af det anførte, at fællesskabsinstitutionerne ikke overskred grænserne for det skøn, som traktaten har tillagt dem, da de konkluderede, at uanset den yderst komplicerede, videnskabelige og tekniske karakter af de spørgsmål, de skulle tage stilling til i nærværende sag, kunne de under de særlige og ekstraordinære omstændigheder i den konkrete sag gennemføre en videnskabelig vurdering, der var så udtømmende som mulig, af de risici, der er forbundet med anvendelsen af zinkbacitracinsom tilsætningsstof til foderstoffer, uden at have rådet over en videnskabelig udtalelse fra SCAN om dette konkrete produkt og uden at have afventet den videnskabelige rapport fra VSK
Under the precautionary principle the Community institutions are entitled, in the interests of human health to adopt, on the basis of as yet incomplete scientific knowledge, protective measures which may seriously harm legally protected positions, and they enjoy a broad discretion in that regard.
Alpharma, som herved især har henvist til de sagkyndige videnskabelige udtalelser fra professorerne M.W. Casewwell og H. Hellig, har gjort gældende, at forbuddet mod zinkbacitracin sandsynligvisvil have betydelige skadevirkninger for menneskers og dyrs sundhed.
First, it was necessary, in the case of additives other than bacitracin zinc, to follow the procedure laid down in Article 24 of Directive 70/524 in order to withdraw an additive in respect of which a safeguard measure had been taken by a Member State.
Alpharma har således anført, at forbuddet mod brug af zinkbacitracin fører til en større anvendelse inden for veterinærmedicin af erstatningsantibiotika, der også anvendes på
Second, in the case of bacitracin zinc, the Community institutions had to apply the procedure laid down in Article 23 of that directive, since no safeguard
I denne situation er det også i overensstemmelse med forsigtighedsprincippet, når fællesskabsinstitutionerne på grundlag af deres vide skønsmargin og deres ansvarfor at fastlægge den offentlige sundhedspolitik, som de anser for den mest hensigtsmæssige, besluttede ikke at afvente gennemførelsen af en mere dybtgående videnskabelig forskning af spørgsmålet om zinkbacitracinresistens, men foreløbig og på grundlaguf den foreliggende videnskabelige viden at træffe præventive foranstaltninger over for dette produkt.
However, according to the settled caselaw of the Court of Justice and the Court of First Instance, in such circumstances, the guarantees conferred by the Community legal order in administrative proceedings are of even more fundamental importance. Those guarantees include, in particular, the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (Case C269/90 Technische Universität München [1991], paragraph 14).
Det fremgår i øvrigt af disse rapporter, at det samlede forbrug af antibiotika i husdyravl er blevet formindsket siden forbuddet mennesker. Alpharma har forklaret, at zinkbacitracin har en profylaktisk virkning mod nekrotisk enteritis, som det — hvis zinkbacitracin ikke benyttes — er nødvendigt at underkaste en behandling, der indebærer anvendelse afstærkere antibiotika fra den nye generation, såsom amoxycillin og ampiciUin.
It follows, as Alpharma has rightly submitted, that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures.
I undersøgelser, der er gennemført efter vedtagelsen af den anfægtede forordning, bekræftes det, at der er indtrådt en sådan øget anvendelse af disse produkter. Disse sidstnævnte antibiotika finder imidlertid langt større anvendelse på mennesker, aktuelt såvel som potentielt, end zinkbacitracin.
It is in the light of the foregoing that the Court must examine whether the risk assessment carried out by the Community institutions in the present case is vitiated by the errors alleged by Alpharma.
Den øgede anvendelse af disse andre antibiotika til behandlingsformål indebærer følgelig en større risiko for menneskers sundhed end brugen af zinkbacitracinsom tilsætningsstof til foderstoffer.
The Court finds that Alpharma has not demonstrated that the Community institutions erred in concluding, on the basis of the factual evidence available at the time of adoption of the contested regulation, that the use of bacitracin zinc as a growth promoter constituted a risk for human health.
Alpharma bemærker endvidere, at forbuddet mod zinkbacitracin indebærer en større risiko for inficering af kød med fækale bakterier som følge af brud på fjerkræets tarmvæg under forarbejdningen, for det er bevist, at behandling af fjerkræ med dette produkt styrker deres tarme.
It is clear, on the contrary, that they could reasonably take the view that there were serious reasons concerning human health, within the meaning of Article 3a(e) of Directive 70/524, why bacitracin zinc, as an antibiotic with a dual use as an additive in feedingstuffs and at the same time as a medicinal product for human use, should be confined to medical use.
Følgelig medfører den anfægtede forordning efter Alphannas opfattelse reelt den risiko for menneskers sundhed, som den søger at begrænse, og er en åbenbar uegnet foranstaltning i forhold til det forfulgte mål.
In essence, Alpharma is criticising the Community institutions for not having based their scientific assessment of the risks specifically associated with bacitracin zinc on appropriate scientific material.
Således som Alpharma har understreget, fremgår det imidlertid af disse rapporter, at de forholdsvis positive resultater, der er konstateret i Sverige, til dels kan forklares med den lave dyretæthed i dette land (hvis andel af fællesskabsproduktionen ikke overstiger 1,5%) sammenlignet med andre medlemsstater, såsom Danmark, Nederlandene og Frankrig, der er betydelige kødproducenter på fællesskabsniveau, hvor der anvendes mere intensive avlsmetoder.
Under the provisions applicable to the present case, there is nothing to preclude the Community institutions, in the absence of a SCAN opinion or of a scientific report from the SSC, from assessing the risks specifically associated with bacitracin zinc on the basis of information contained in the SCAN opinions relating to the other antibiotics whose authorisation was withdrawn by the contested regulation and in the reports of the various international, Community and national bodies.
Rådet, der navnlig støttes af Republikken Finland og Kongeriget Sverige, afviser denne argumentation.
As to whether the Community institutions were entitled to carry out a scientific assessment of the risks associated with the use of bacitracin zinc as an additive in feedingstuffs without having a SCAN opinion relating to that use of the product and without awaiting the scientific report of the SSC, the Court makes the following findings.
Rådet og de nævnte intervenienter finder, at de erfaringer, der er gjort i disse lande efter forbuddet mod anvendelsen af antibiotika som vækstfremmemidler, ikke styrker Alpharmas argumentation.
It follows from the foregoing analysis that, on the basis, first, of the SCAN opinions concerning the other antibiotics whose authorisations were withdrawn by the contested regulation and, second, of the reports on antimicrobial resistance of the various international, Community and national bodies referred to at paragraphs 37 and 44 above, the Community institutions were entitled to decide upon a coherent general public health policy on the use of antibiotics as additives in feedingstuffs and, in so doing, to adopt provisional preventive measures in respect of those antibiotics which were also authorised for use in human medicine.
Tværtimod har man ved at forbedre fremgangsmåderne i husdyravlen og s u ndheds beti ngel sentei staldene kunnet reducere brugen af antibiotika i behandlingsøjemed og samtidig kunnet opretholde konkurrenceevnen for husdyravlerne i disse lande.
Despite the as yet incomplete state of scientific knowledge in that area, that general policy was decided upon on the basis of the best scientific data available at the time of adoption of the contested regulation and corresponds to the opinions on the subject expressed by the great majority of scientists.
Det bemærkes under alle omstændigheder, at det forhold, som bekræftes af visse dokumenter i sagen — såsom den sagkyndige udtalelse fra professor H. Hellig såvel som rapporten fra TNO Nutrition and Food Research Institute (»A risk assessment of the use of bacitracin as growth promoting substance for animals«) af 8. december 1998, som sagsøgeren blot har forelagt Retten i form af et resumé - at brugen af zinkbacitracinsom tilsætningsstof til foderstoffer har visse gavnlige virkninger for menneskers sundhed, fordi der i mindre omfang bruges antibiotika på dyr i behandlingsøjemed, ikke med føje kan påberåbes afAlpharma.
In the light of the foregoing, it must be concluded that, contrary to Alpharma's contention, the fact that the Council, acting on a proposal from the Commission, withdrew the authorisation of bacitracin zinc as an additive in feedingstuffs without having a SCAN opinion and without waiting until the SSC had delivered its scientific report does not of itself mean that the contested regulation is illegal as concerns bacitracin zinc.
Forekomsten af sådanne gavnlige virkninger kan nemlig ikke i sig selv bevise, at forbuddet mod zinkbacitracin som vækstfremmemiddel er en åbenbart uegnet foranstaltning, når det gør det muligt at mindske resistensen hos dyr og risikoen for overførsel til mennesker.
However, it remains to examine whether the Community institutions made a manifest error of assessment in concluding, on the basis of the other factual evidence, that the use of bacitracin zinc as a growth promoter constituted a risk to human health.
ophør med brugen af antibiotika såsom zinkbacitracin vil nødvendiggøre en ændring af metoderne i husdyrbruget for at nå det mål at mindske resistensen hos dyr og risikoen for overførsel til mennesker og undgå, at andre antibiotika anvendes på dyr i behandlingsøjemed i for stort omfang, er forholdet dog det, at vedtagelsen af en sådan foranstaltning tilkommer fællesskabslovgiver, som traktaten har pålagt ansvaret for at fastlægge den politik, som lovgiver finder mest hensigtsmæssig, og beføjelsen til, hvis det findes nødvendigt, at foretage en omlægning af den fælles landbrugspolitik.
In those circumstances, it was also in keeping with the precautionary principle that the Community institutions decided, in the context of their broad discretion and their responsibility for defining the public health policy which they deem most appropriate, not to await completion of more thorough research into the transfer of resistance to bacitracin zinc but to adopt, on a provisional basis and in reliance on available scientific knowledge, preventive measures in respect of that product.
Der kan følgelig ikke gives Alpharma medhold i argumentationen om, at den anfægtede forordning er åbenbart uegnet på grund af de skadelige virkninger af tilbagekaldelsen af godkendelsen af zinkbacitracin for dyrs og i sidste ende menneskers sundhed.
That conclusion is also borne out by the fact that, in acting consistently with their general policy on the use of antibiotics as additives in feedingstuffs, the Community institutions decided not to withdraw the authorisations of antibiotics which, at the time of adoption of the contested regulation, were not used in human medicine and were not known to select for cross-resistance to antibiotics used in human medicine.
Spørgsmålet om forpligtelsen til at træffe mindre indgribende foranstaltninger
In view of all of the foregoing, the Court concludes that Alpharma has not succeeded in proving that the Community institutions made errors in their risk assessment.
Alpharma har først mindet om, at det er almindeligt antaget af de videnskabelige eksperter, at udviklingen af antibiotikaresistens hos mennesker først og fremmest skyldes den overdrevne og uhensigtsmæssige brug af antibiotika i humanmedicin.
Alpharma argues that the contested regulation was adopted in breach of the principle of proportionality inasmuch as it is a manifestly inappropriate means of achieving the objective pursued and the Community institutions, which had a choice between a number of measures, failed to choose the least onerous one.
Denne situation kan imidlertid ikke afhjælpes med vedtagelsen afden anfægtede forordning.
In the particular case of bacitracin zinc, even without a scientific report relating specifically to that product, the Community institutions were entitled to note that at the time of adoption of the contested regulation, very little scientific research had been carried out in respect of that product.
Derimod burde fællesskabsinstitutionerne ifølge Alpharma i første række træffe foranstaltninger med henblik på at begrænse det ukontrollerede salg af antibiotika, herunder zitikbat itraci n, uden recept. I betragtning af den ubetydelige anvendelse af zinkbacitracin i humanmedicin, især sammenlignet med den udbredte anvendelse heraf hos dyr, ville disse foranstaltninger ikke alene have været mindre belastende, men også mere effektive.
However, on the basis of the SCAN opinions on the other antibiotics and the reports on antimicrobial resistance drawn up by the various international, Community and national bodies, they had sufficient scientific material for the purpose of assessing the functioning of the mechanism of the transfer of antimicrobial resistance in general, to find that bacitracin zinc came within the category of antibiotics having a dual use as an additive in feedingstuffs and as a medicinal product which was currently employed, and might in the future be employed, in human medicine and to conclude, in full knowledge of the facts, that the arguments put forward by Alpharma did not allow them to depart, in the case of bacitracin zinc, from the general policy of imposing a temporary ban on any dual use of antibiotics.
Denne konklusion bekræftes af udtalelsen fra Det Økonomiske og Sociale Udvalg (punkt 4.2 i udtalelsen), hvori udvalget bemærker, at »en rationel brug af antibiotika kun kan sikres effektivt, hvis det frie salg af disse produkter afskaffes«.
The Court observes in limine that the principle of proportionality, which is one of the general principles of Community law, requires that measures adopted by Community institutions should not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question, and where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (Case C-331/88 Fedesa and Others [1990], paragraph 13).
Retten finder, at selv om det antages, at fællesskabsinstitutionernehavdehaftkompetence og pligt til at træffe visse andre foranstaltninger med henblik på at forebygge den overdrevne og uhensigtsmæssige brug af antibiotika i
It follows that the Community institutions did not exceed the bounds of the discretion conferred on them by the Treaty when they concluded that, notwithstanding the highly complex and technical nature of the questions with which they were required to deal in this instance, they could, in the special and exceptional circumstances of the present case, carry out as thorough as possible a scientific assessment of the risks associated with the use of bacitracin zinc as an additive in feedingstuffs even though they did not have a SCAN opinion relating to that particular product
zinkbacitracin fandt anvendelse både i humanmedicin og som tilsætningsstoffer til foderstoffer, og samtidig videreføre den igangværende videnskabelige forskning, der navnlig også vedrørte spørgsmålet om resistens over for dette sidstnævnte produkt Denne fremgangsmåde, hvormed formålet var at undgå, at risikoen for overførsel af resistens blev en realitet, var i overensstemmelse med forsigtighedsprincippet, ifølge hvilket den offentlige myndighed kan være forpligtet til at gribe ind, selv før der er indtrådt skadevirkninger.
It is clear from the various reports that, although significant difficulties with animal health arose in the first three years following Sweden's ban on the use of antibiotics as growth promoters, considerable progress has been made in terms of hygiene, so that those difficulties have been overcome in recent years. Furthermore, those reports reveal that the total consumption of antibiotics in farming has been reduced since the ban was introduced.
Denne konklusion kan ikke afkræftes med henvisning til, at Alpharma har foretaget væsentlige investeringer for at bringe zinkbacitracin på markedet, og at produktet var blevet anvendt i en meget lang periode.
In effect, according to Alpharma, the ban on the use of bacitracin zinc entails an increased veterinary use of alternative antibiotics also used for humans.
Der må herved mindes om, at det mål, der forfølges med den anfægtede forordning, nemlig beskyttelsen af menneskers sundhed, på grund af sin betydning kan begrunde selv væsentlige negative økonomiske følger for visse erhvervsdrivende (Domstolens dom af 17.7.1997, sag C-183/95, Affish, præmis 42, og dommen i sagen Fedesa m.fl., nævnt ovenfor, præmis 17).
Bacitracin zinc has a prophylactic effect against necrotic enteritis, which, if bacitracin zinc is not used, requires treatment with more powerful new-generation antibiotics, such as amoxycillin and ampicillin.
I denne forbindelse må beskyttelsen af den offentlige sundhed, som den anfægtede forordning skal sikre, tillægges større vægt end økonomiske overvejelser (Affish-dommen, præmis 43).
Research completed since the contested regulation was adopted confirms that use of those products has increased.
Det må ikke desto mindre fremhæves, at der i årene forud for vedtagelsen af den anfægtede forordning fremkom stadig flere udtalelser fra videnskabelige eksperter, hvorefter enhver dobbeltanvendelse af antibiotika som tilsætningsstoffer til foderstoffer og som humanmedicinske lægemidler indebar en risiko for menneskers sundhed.
Current and potential human use of those antibiotics is much greater than that of bacitracin zinc, so that the increased use of those other antibiotics for therapeutic purposes involves a higher risk for human health than the use of bacitracin zinc as an additive in feedingstuffs.
Det er endvidere fastslået, at der i denne periode var blevet gennemført nye videnskabelige forsøg og undersøgelser vedrørende overførsel af antimikrobiel resistens.
Alpharma also states that the ban on bacitracin zinc will increase the risk of meat being contaminated by faecal bacteria owing to rupture of the intestinal wall in poultry during processing, since it is established that treatment of chickens with bacitracin zinc strengthens their intestines.
Selv om disse videnskabelige arbejder ikke specielt vedrørte zinkbacitracin og ikke gjorde det muligt med sikkerhed at påvise en forbindelse mellem brugen af tilsætningsstoffer hos dyr og antimikrobiel resistens hos mennesker, tilvejebragte de dog en bedre forståelse af, hvorledes resistensen overføres som sådan, og kunne med rimelighed betragtes som videnskabelige angivelser af, at en sådan forbindelse foreligger med hensyn til zinkbacitracin.
However, as Alpharma has pointed out, it is clear from those reports that the relatively positive results observed in Sweden can, in part, be explained by the low density of animals in that country (whose share of Community production does not exceed 1.5%), as compared with other Member States, such as Denmark, the Netherlands or France, which are large Community meat producers and which have more intensive farming methods.