natgillin/translations-raw huggingface dataset:
Implants of progesterone may not be so authorised.
Dajanje zdravila v obliki podkožnih vstavkov torej ni dovoljeno. Zato menim, da Uredba �t.
I therefore consider that Regulation No 1873/2003 by limiting the mode of administration of progesterone to intravaginal use effectively departs from the terms of Article 4(1) of Directive 96/22.
1873/2003 s tem, da način dajanja progesterona omejuje le na intravaginalno uporabo, dejansko izhaja iz besedila člena 4(1) Direktive 96/22.
Moreover, in my view the effects of the limitations on the mode of administration of progesterone imposed by Regulation No 1873/2003 are not merely declaratory in nature but are binding and legislative in character.
Nadalje po mojem mnenju učinki omejitev načina dajanja progesterona, ki jih določa Uredba �t. 1873/2003, niso zgolj deklaratorni, ampak so zavezujoče zakonske narave.
Indeed the binding nature of the limitations imposed by Regulation No 1873/2003 was confirmed by the agent for the Commission at the hearing on 18 October 2007.
Zavezujočo naravo omejitev, določenih z Uredbo �t. 1873/2003, pa je potrdil tudi predstavnik Komisije na obravnavi 18. oktobra 2007.
The first recital in the preamble to Regulation No 2377/90 states that the use of veterinary medicinal products in foodproducing animals may result in the presence of residues in foodstuffs obtained from treated animals.
Prva uvodna izjava Uredbe �t. 2377/90 določa, da se lahko zaradi uporabe zdravil v veterinarski medicini pri živalih za proizvodnjo hrane pojavijo ostanki v živilih, pridobljenih iz zdravljenih živali.
21Regulation No 2377/90 lays down a Community procedure in accordance with which pharmacologically active substances in veterinary medicinal products administered to foodproducing animals are assessed with a view to determining whether those substances result in the presence of residues in animal tissues which are harmful to public health and accordingly whether the substances should be placed in Annexes I to IV to that regulation.
2377/90 določa postopek Skupnosti, v skladu s katerim se farmakolo�ko aktivne snovi v zdravilih za uporabo v veterinarski medicini, ki se dajejo živalim za proizvodnjo živil, presoja tako, da se določi, ali se te snovi izražajo v ostankih v tkivih živali, ki so �kodljivi za javno zdravje, in ali je treba v skladu s tem te snovi vključiti v priloge od I do IV k tej uredbi.
22 The Council has delegated the primary task of determining whether such substances should be placed in Annexes I to IV to Regulation No 2377/90 to the Commission, in accordance with the procedure laid down in Article 6 et seq. of that regulation.
22 Svet je primarno nalogo določanja, ali je te snovi treba uvrstiti v priloge od I do IV k Uredbi �t. 2377/90, prenesel na Komisijo v skladu s postopkom, določenim v členu 6 in naslednjih te uredbe.
21 — See the fourth recital in the preamble to Regulation No 2377/90.
21 – Glej četrto uvodno izjavo Uredbe �t. 2377/90.
22 — See point 5 above for an explanation of the reasons for classifying a substance in Annexes I to IV of Regulation No 2377/90.
22 – Glej točko 5 zgoraj za razlago razlogov za vključitev snovi v priloge od I do IV Uredbe �t. 2377/90.
The question therefore arises whether the Commission has the competence pursuant to Regulation No 2377/90 to impose binding limitations on the mode of administration of a substance when placing it in Annex II to that regulation and, if so, whether those limitations may be more restrictive than the terms of Article 4(1) of Directive 96/22, as amended, concerning the same substance.
Pojavi se vpra�anje, ali je Komisija v skladu z Uredbo �t. 2377/90 pristojna, da določi zavezujoče omejitve načina dajanja snovi pri vključitvi te snovi v Prilogo II k tej uredbi, in če je tako, ali so lahko te omejitve glede iste snovi strožje kot določbe člena 4(1) Direktive 96/22, kot je bila spremenjena.
CP-PHARMA the SCVPH had repeatedly confirmed that the use of hormones for growth promotion purposes in meat production poses a potential health risk to consumers.
CP-PHARMA hormonov za pospe�evanje rasti pri proizvodnji mesa pomeni mogoče tveganje za zdravje potro�nikov.
In the same recital the Commission also highlighted the fact that there were insufficient data available on progesterone to make a quantitative estimate of the risk arising from the exposure to residues in meat and meat products originating from treated animals.
V tej uvodni izjavi je Komisija tudi poudarila, da podatki, ki so trenutno na voljo o progesteronu, ne zado�čajo za kakr�no koli količinsko oceno tveganja zaradi ostankov v mesu in mesnih izdelkih, ki so pridobljeni iz zdravljenih živali.
No threshold therefore was defined for progesterone by Regulation No 1873/2003.
Uredba �t. 1873/2003 za progesteron ni določila nobenega praga. Ta snov je bila uvr�čena v Prilogo II k Uredbi �t.
The 10th recital in the preamble to Regulation No 1873/2003 provides that the restrictions imposed by that regulation on the mode of administration of progesterone to animals of the bovine species are aimed at creating an additional safeguard against the possible misuse of veterinary medicinal products containing progesterone.
Deseta uvodna izjava Uredbe �t. 1873/2003 določa, da so omejitve te uredbe glede načina dajanja progesterona pri govedu dodatni za�čitni ukrep, ki je potreben, da bi se izognili zlorabi zdravil z vsebnostjo progesterona za uporabo v veterinarski medicini.
The categorisation of substances pursuant to Articles 2 to 5 of Regulation No 2377/90 is of considerable importance due, in particular, to the terms of Article 14 thereof which provide in substance that the administration to foodproducing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annexes I, II or III to that regulation is prohibited.
Uvrstitev snovi v skladu s členi od 2 do 5 Uredbe �t. 2377/90 je pomembna zlasti za določbo člena 14 te uredbe, po kateri je dajanje zdravil za uporabo v veterinarski medicini, ki vsebujejo farmakolo�ko aktivne snovi, ki niso na�tete v prilogah I, II in II k tej uredbi, živalim za proizvodnjo živil prepovedano.
Moreover, Article 6(1) of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products 23ensures that a veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more foodproducing species unless the pharmacologically active substances which it contains appear in Annexes I, II or III to Regulation No 2377/90.
Dalje, Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini 23zagota-vlja, da zdravilo za uporabo v veterinarski medicini ne more biti predmet dovoljenja za promet za namen dajanja teh zdravil eni ali več vrstam za proizvodnjo živil, razen če se farmakolo�ko aktivne snovi, ki jih vsebuje, nahajajo v prilogah I, II ali II k Uredbi �t. 2377/90.
In Monsanto, 24the Court highlighted the fact that the pro -cedures for establishing MRLs and issuing marketing authorisations are inherently linked, inasmuch as a marketing authorisation will not be issued in respect of a vet -erinary medicinal product for administration to foodproducing animals unless an MRL has been established, and, by the same token, an MRL will not be established for a new pharmacologically active substance unless that substance is intended to be placed on the market. 25
V sodbi Monsanto 24je Sodi�če poudarilo, da so postopki za določanje NMVO in dovoljenja za promet po naravi povezani, ker dovoljenja za promet ne bodo izdana za zdravila za uporabo v veterinarski medicini za dajanje živalim za proizvodnjo hrane, razen če so bile določene NMVO in, iz istega razloga, NMVO ne bodo določene za novo farmakolo�ko aktivno snov, razen če se to snov namerava dati v promet. 25
As regards the present case, the Commission outlined in the sixth recital in the preamble to Regulation No 1873/2003 that
Glede tega primera je Komisija v �esti uvodni izjavi Uredbe �t. 1873/2003 opisala, da je SCVPH večkrat potrdil, da uporaba
1.24 — C-248/99 P [2002] ECR I-1.25 — See paragraph 80.
1.24 – Sodba z dne 8. januarja 2002, C-248/99 P, Recueil, str. I-1.25 – Glej točko 80.
The Commission explained in considerable detail in its pleadings that, due to the particular characteristics of certain substances, the mode of administration of those substances may have a direct impact on the level of residues in animal tissues.
Komisija je na obravnavi natančno pojasnila, da lahko zaradi določenih značilnosti določenih snovi način dajanja teh snovi neposredno vpliva na stopnjo ostankov v tkivih živali.
In relation to the substance progesterone the Commission, in response to a written question put to it by the Court, asserted that the mode of administration of progesterone influenced the level of residues of that substance in animal tissues.
Glede snovi progesteron se je Komisija v odgovoru na pisno vpra�anje Sodi�ča zagovarjala, da je način dajanja progesterona vplival na stopnjo ostankov te snovi v tkivih živali. Komisija je navedla, da količina progesterona, če se daje v obliki nožničnih spiral, upade, takoj ko se zdravilo izloči iz telesa živali.
The Commission also stated that due to the fact
Komisija je navedla tudi, da nožnične spirale, ker vsebujejo veliko količino progesterona, v praksi niso primerne za pospe�evanje rasti, saj lahko dani odmerek �kodi telesu živali, če dajanje traja dalj časa.
that vaginal spirals administer a large dose of progesterone, they are not suitable in practice for growth promotion as the dose administered may detrimentally affect an animal’s health if continued over a period of time.
Nadalje je Komisija povedala, da je obstajalo tveganje za zlorabo progesterona v obliki injekcije, ker se brez težav lahko uporabi za dajanje majhnih odmerkov progesterona, ki lahko pospe�ijo rast.
In add -ition, the Commission stated that there was a risk of misuse of progesterone in injectable form as it can easily be used to administer small doses of progesterone which can stimulate growth.
Predložitveno sodi�če tudi dvomi, da dajanje progesterona z intramuskularno aplikacijo (injekcijo) povzroči ostanke, ki zahtevajo prepoved te oblike snovi zaradi varovanja javnega zdravja.
It is clear from Commission v CEVA and Pfizer 26 that the Commission, when carrying
Iz sodbe Komisija proti CEVA in Pfizer 26izhaja, da ima Komisija pri presoji
As can seen in particular from the sixth, ninth and 10th recitals in the preamble to Regulation No 1873/2003 and the submissions of the Commission presented to the Court, the Commission has drawn a direct correlation between the mode of administration of progesterone, the misuse of that substance for growth promotion and the presence and quantity of progesterone residues in animal tissues.
Kot je očitno zlasti iz �este, devete in desete uvodne izjave Uredbe �t. 1873/2003 in trditev Komisije, ki so bile predložene Sodi�ču, je Komisija ugotovila neposredno povezavo med načinom dajanja progesterona, zlorabo te snovi za pospe�evanje rasti ter prisotnost in količino ostankov progesterona v tkivih živali.
out its assessment of a pharmacologically active substance for the purpose of fixing a MRL pursuant to the procedure contained in Regulation No 2377/90, enjoys a broad margin of appreciation.
farmakolo�ke aktivne snovi za določanje NMVO v skladu s postopkom iz Uredbe �t. 2377/90 �iroko diskrecijsko pravico.
In my view, the same margin of appreciation also undoubtedly extends to the Commission’s decision to place a substance in Annex II to Regulation No 2377/90.
Menim, da ima Komisija enako diskrecijsko pravico nedvomno tudi pri odločanju glede vključitve snovi v Prilogo II k Uredbi �t. 2377/90.
27 This is particularly so in a case such as the present where a comparison of the pleadings of the parties, the terms of the preliminary reference and the legislative history leading to the adoption of Regulation No 1873/2003 demonstrate that there is considerable ongoing scientific uncertainty in relation to the effect on public health of progesterone in the tissue of foodproducing animals.
27Tako je zlasti v primeru, kot je ta, v katerem primerjava med trditvami strank, besedilom vpra�anja za predhodno odločanje in zgodovino zakonodaje, ki je vodila k sprejetju Uredbe �t. 1873/2003, kaže, da obstaja velika znanstvena negotovost glede učinka progesterona v tkivih živali za proizvodnjo hrane na javno zdravje.
Indeed, the Court acknowledged in Commission v CEVA and Pfizer that the
Sodi�če pa je v sodbi Komisija proti CEVA in Pfizer priznalo, da je bil položaj glede progesterona zelo kompleksen, saj gre za endogeno snov in ni zanesljivega
27 — In accordance with the third recital in the preamble to Regulation No 2377/90, MRLs are to be established in accordance with generally recognised principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned which may have been undertaken by international organisations.
27 – Tretja uvodna izjava Uredbe �t. 2377/90 določa, da je MVO treba določiti v skladu s splo�no priznanimi načeli presoje varnosti, ob upo�tevanju drugih znanstvenih presoj varnosti zadevnih snovi, ki bi jih lahko opravljale mednarodne organizacije.
Moreover, the sixth recital in the preamble to Regulation No 2377/90 states that the procedure for the establishment of MRLs at Community level must involve a single scientific assessment of the highest possible quality.
Nadalje �esta uvodna izjava k Uredbi �t. 2377/90 določa, da mora Skupnost postopek za določanje MVO določiti po čim bolj kakovostni enotni znanstveni presoji.
In my view, equivalent standards apply when a substance is placed in Annex II to Regulation No 2377/90.
Menim, da se enakovredni standardi uporabijo, ko se snov uvrsti v Prilogo II k Uredbi �t. 2377/90.
In contrast, it should be noted that cp-Pharma stated, in response to a written question put to it by the Court, that it could not indicate whether the mode of administration of progesterone had an effect on the quantity of residues without carrying out a study on the residues concerned.
Nasprotno pa je treba povedati, da je cp-Pharma kot odgovor na pisno vpra�anje, ki ga je zastavilo Sodi�če, navedla, da ni mogla določiti, ali je način dajanja progesterona vplival na količino ostankov, brez �tudije o teh ostankih.
Moreover, cp-Pharma indicated that the intravaginal
Nadalje je cp-Pharma povedala, da intravaginalna uporaba progesterona lahko pospe�uje rast, če je stopnja
28 ensuring that the presence or quantity of residues in animal tissues do not pose a risk to public health.
30 Menim, da je možnost, da Komisija določi omejitve glede načina dajanja snovi iz Priloge II k Uredbi �t.
30 In my view, the possibility for the Commission to impose limitations on the mode of administration of a substance placed in Annex II to Regulation No 2377/90, where those limitations are aimed at ensuring that the presence or quantity of residues of that substance in animal tissues do not pose a risk to public health, is in line with the Community’s precautionary principle. 31
2377/90, v kateri je namen teh omejitev zagotoviti, da obstoj ali količina ostankov te snovi v tkivih živali ne pomeni tveganja za javno zdravje, v skladu s previdnostnim načelom Skupnosti. 31
Moreover, I consider that this approach is not at variance with the statement of the Court at paragraph 55 of the Boehringer case which must be interpreted in the context of the specific facts of that case.
Nadalje menim, da je ta pristop v nasprotju z ugotovitvijo Sodi�ča v točki 55 sodbe Boehringer, ki jo je treba razlagati glede na specifična dejstva te zadeve.
The Boehringer case concerned limitations placed on a substance relating to certain therapeutic indications rather than the mode of administration of a particular substance.
Sodba Boehringer se je nana�ala na omejitve, določene za snovi, bolj glede določenih terapevtskih indikacij kot glede načina dajanja posamezne snovi.
I believe that the circumstances in the Boehringer case may be distinguished from those of the present as, it is arguable that in contrast to the mode of administration of a substance,
Verjamem, da so okoli�čine v sodbi Boehringer lahko drugačne
30 — Therefore, limitations may not be imposed on the mode of administration of substances listed in Annex II to Regulation No 2377/90 unless they are directed at ensuring that the presence or quantity of residues in animal tissues do not harm human health.
30 – Torej omejitev ni mogoče določiti glede načina dajanja snovi, določene v Prilogi II k Uredbi �t. 2377/90, razen če je njihov namen zagotoviti, da obstoj ali količina ostankov v tkivih živali ne �koduje javnemu zdravju.
In my view, while Articles 1(1) 29and 3 of Regulation No 2377/90 do not specifically provide for the possibility of imposing conditions on the mode of administration of a particular substance listed in Annex II to that regulation, it cannot be excluded that there may be instances where the Commission’s decision to place a particular substance in Annex II is based on the finding that the substance in question is not apt to be placed in Annexes I, III and IV to Regulation No 2377/90 and that that substance, when administered in a particular manner, does not give rise to residues in animal tissues which are harmful to public health.
2377/90 ne določata natančno možnosti za določanje pogojev glede načina dajanja določenih snovi, na�tetih v Prilogi II k tej uredbi, menim, da ni mogoče izključiti obstoja primerov, ko odločitev Komisije, da določeno snov uvrsti v Prilogo II, temelji na ugotovitvi, da zadevne snovi ni mogoče uvrstiti v priloge I, III in IV k Uredbi �t. 2377/90 in da ta snov, ko se jo daje na določen način, ne povzroča ostankov v tkivih živali, ki so �kodljivi za javno zdravje.
In such cases, I consider that the Commission will not have exceeded its delegated powers pursuant to Regulation No 2377/90 and acts within the scope of its margin of appreciation where it places the substance in question in Annex II to that regulation and imposes limits on the mode of administration of the substance which are directly aimed at and circumscribed to
V takih primerih menim, da Komisija ne prekorači pooblastil, prenesenih v skladu z Uredbo �t. 2377/90, in pri vključitvi zadevne snovi v Prilogo II k tej uredbi ravna v okviru svoje diskrecijske pravice ter določa meje glede načina dajanja snovi, ki so neposreden cilj in so opisane z namenom, da se zagotovi, da obstoj ali količina ostankov v tkivih živali ne pomeni tveganja za javno
31 — For an expression of this principle in the field of public health, see in particular, Articles 3(p) EC, 152(1) EC and 153(1) and (2) EC.
31 – Glede izražanja tega načela na področju javnega zdravja glej zlasti člene 3(p) ES, 152(1) ES, 153(1) in (2) ES.
29 — Which establishes a definition of the terms ‘residues of veterinary medicinal products’ and ‘maximum residue limit’ (see point 4 above).
Opozoril bi, da je člen 7(1) Uredbe 178/2002 konkreten izraz previdnostnega načela na področju živilske zakonodaje.
33 the effect on public health of residues of a substance in animal tissues is not dependent on the therapeutic indications for which the substance was administered. 32
33 od tistih v tem primeru, saj je sporno, da v nasprotju z načinom dajanja snovi učinek na javno zdravje ostankov snovi v tkivih živali ni odvisen od terapevtskih indikacij, zaradi katerih je bila snov dana. 32
I would add however an important caveat to the foregoing.
Glede zgoraj navedenega bi dodal �e opozorilo.
According to Article 15 of Regulation No 2377/90, that regulation shall in no way prejudice the application of Community legislation prohibiting the use in livestock farming of certain substances having a hormonal action.
Člen 15 Uredbe �t. 2377/90 določa, da uredba nikakor ne sme posegati v zakonodajo Skupnosti, ki prepoveduje uporabo nekaterih snovi s hormonskim delovanjem v živinoreji.
34 In my view, any implementing legislation adopted by the Commission pursuant to Regulation No 2377/90 must comply with the clear terms of Article 15 thereof.
34 Menim, da mora biti vsaka izvedbena zakonodaja, ki jo je sprejela Komisija v skladu z Uredbo �t. 2377/90, v skladu z jasno določbo člena 15 te uredbe.
While Article 15 of Regulation No 2377/90 does not specifically refer to Directive 96/22, I consider that that directive, which seeks, inter alia, to prevent the misuse of certain hormones including progesterone in stockfarming, is covered by the terms of Article 15 of that regulation.
Čeprav se člen 15 Uredbe �t. 2377/90 ne sklicuje izrecno na Direktivo 96/22, menim, da se ta direktiva, ki želi inter alia preprečiti zlorabo določenih hormonov v živinoreji, nana�a na določbo člena 15 te uredbe.
The Commission is thus obliged pursuant to Article 15 of Regulation No 2377/90 when categorising a substance in Annexes I to IV to that regulation not to derogate from the terms of Dir ective 96/22, as amended, including Article 4(1) thereof which forms an integral part of that directive.
Komisija torej v skladu s členom 15 Uredbe �t. 2377/90 pri vključevanju snovi v priloge I do IV k tej Uredbi ne sme odstopati od besedila Direktive 96/22, kot je bila spremenjena, vključno s členom 4(1), ki je bistveni del te direktive.
35 Given that
35 Ker se določbe Uredbe �t.
In my view, the Commission, notwithstanding its broad margin of appreciation, must, when imposing limitations on the mode of administration of a substance included in Annex II to Regulation No 2377/90, stay within the confines of the legislative power delegated to it by the Council and comply, inter alia, with all the basic elements of that regulation.
Menim, da mora Komisija kljub �iroki diskrecijski pravici pri določanju omejitev glede načina dajanja snovi iz Priloge II k Uredbi �t. 2377/90 ostati v mejah zakonodajnih pooblastil, ki jih je nanjo prenesel Svet, in v skladu inter alia z vsemi temeljnimi določbami te uredbe.
In that regard, the Court has held that the Commission is authorised to adopt all the implementing measures which are necessary or appropriate for the implementation of the basic legislation, provided that they are not contrary to such legislation or to
Glede tega je Sodi�če odločilo, da Komisija lahko sprejme vse izvedbene ukrepe, ki so nujni ali primerni za izvajanje temeljne zakonodaje, če niso v
See also in relation to the Community Customs Code Case C-48/98 Söhl & Söhlke [1999] ECR I-7877, paragraph 36. 34 — See also Article 7(6) of Regulation No 2377/90 pursuant to which the Commission is obliged to prepare draft measures taking account of Community legislation.
Glej tudi sodbo v povezavi s Carinskim zakonikom Skupnosti z dne 11. novembra 1999 v zadevi Söhl & Söhlke, C-48/98, Recueil, str. I-7877, točka 36. 34 – Glej tudi člen 7(6) Uredbe �t. 2377/90, ki določa, da mora Komisija pripraviti osnutke ob upo�tevanju zakonodaje Skupnosti.
32 — See Opinion of Advocate General Ruiz-Jarabo Colomer in Commission v Boehringer Ingelheim Vetmedica and C. H. Boehringer Sohn (cited in footnote 12), point 42.
32 – Glej sklepne predloge generalnega pravobranilca Dámasa Ruiz-Jaraboja Colomerja v zadevi, navedeni v opombi 12, Komisija proti Boehringer Ingelheim Vetmedica in C. H. Boehringer Sohn, točka 42.
It follows that the MRLs for a given pharmacologically active substance cannot be determined by reference to the therapeutic properties or indications of that substance, which may be numerous.’
II-3427, v kateri je Sodi�če prve stopnje odločilo, da „[j]e samo po sebi očitno, da ostanki farmakolo�ko aktivne snovi, ki se nahajajo v živilih živalskega izvora, niso niti bolj niti manj nevarni za zdravje v določenem odmerku, če je bila snov dana glede na določeno terapevtsko indikacijo.
The legislative procedure in Article 251 EC, which is also referred to as the co-decision procedure, calls inter alia for the participation of the European Parliament, the Council and the Commission in the legislative process.
1873/2003, ki ni bila sprejeta v skladu s postopkom, določenim v členu 251, posega v zakonodajne pristojnosti tako Evropskega parlamenta kot Sveta in ru�i institucionalno ravnovesje, ki ga zagotavlja Pogodba.