natgillin/translations-raw huggingface dataset:
In my view, Regulation No 1873/2003 which was not adopted in accordance with the procedure laid down by Article 251 EC, encroaches on the legislative powers of both the European Parliament and the Council and thus affects the institutional balance intended by the Treaty.
Zato menim, da je treba trditev zastopnika Komisije na obravnavi, da je sodelovanje Stalnega odbora, ki je za to določen v skladu s členom 8 Uredbe �t.
I therefore consider that the assertion by the agent for the Commission at the hearing that the participation of the Standing Committee provided for pursuant to Article 8 of Regulation No 2377/90 in the procedure leading to the adoption of Regulation No 1873/2003 ensured that the latter regulation was adopted with the agreement or consent of the Council must be rejected.
2377/90 v postopku sprejemanja Uredbe �t. 1873/2003, zagotovilo, da je bila slednja sprejeta s soglasjem ali privolitvijo Sveta, zavrniti.
In my view, aside from the fact that this approach ignores the role of the European Parliament in the legislative procedure provided by Article 251 EC, the Standing Committee referred to in Article 8 of Regulation No 2377/90 cannot act in the place of the Council, where the participation of the Council is specifically required.
Menim, da poleg dejstva, da ta pristop ne upo�teva vloge Evropskega parlamenta v zakonodajnem postopku, določenem v členu 251 ES, Stalni odbor iz člena 8 Uredbe �t. 2377/90 ne more nastopati namesto Sveta, če se sodelovanje Sveta izrecno zahteva.
In my view, any modification of the scope of Directive 96/22, as amended, which is not specifically envisaged by that directive must be carried out pursuant to the legislative procedure provided for in Article 152(4)(b) EC.
Menim, da je treba kakr�no koli spreminjanje področja veljavnosti Direktive 96/22, kot je bila spremenjena, ki ni posebej predvideno s to direktivo, izvesti v skladu z zakonodajnim postopkom, določenim v členu 152(4)(b) ES.
36Pursuant to Article 152(4)(b) EC ‘[t]he Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to
36V skladu s členom 152(4)(b) ES „[S]vet v skladu s postopkom in členom 251 ter po posvetovanju z Ekonomsko-socialnim odborom in odborom regij prispeva k doseganju ciljev iz tega člena s sprejetjem: … ukrepov, z odstopanjem od člena 37, na veterinarskem in fitosanitarnem področju, katerih neposredni cilj je varovanje javnega zdravja“.
In that regard, the Commission’s suggestion at point 35 above, 37that given that
Glede tega je treba predlog Komisije v točki 35 zgoraj, 37da glede na to, da člen
Article 4(1) of Directive 96/22 provides that a veterinary medicinal product must comply with the Community rules concerning
4(1) Direktive 96/22 določa, da mora biti zdravilo za uporabo v veterinarski medicini v skladu s pravili Skupnosti glede dovoljenj
36 — It will be noted that Article 152(4)(b) EC is the legal basis of Directive 2003/74.
36 – Opozarjam, da je člen 152(4)(b) ES pravna podlaga Direktive 2003/74.
37 — See also submissions of the Greek Government at point 31 above.
37 – Glej zgoraj v točki 31 tudi pojasnila gr�ke vlade.
It is evident from the pleadings in this case, the legislative history which preceded the adoption of Regulation No 1873/2003 and the recitals in the preamble to that regulation that the decision of the Commission to place progesterone in Annex II to Regulation No 2377/90 was indissociably linked to limiting the mode of administration of that substance to intravaginal use.
1873/2003 in iz uvodnih izjav te uredbe je očitno, da je bila odločitev Komisije, da progesteron uvrsti v Prilogo II k Uredbi �t. 2377/90, neločljivo povezana z omejevanjem načina dajanja te snovi z intravaginalno uporabo.
I shall also deal with the arguments raised by the Polish Government relating to the inadequacy of reasoning 39 of Regulation No 1873/2003 for the sake of completeness.
Da bo zadeva popolna, bomo preučili tudi trditve poljske vlade glede neustreznosti obrazložitve 39 Uredbe �t. 1873/2003.
According to the settled caselaw relating to Article 253 EC, the scope of the obligation to state reasons depends on the nature of the measure in question.
Iz ustaljene sodne prakse glede člena 253 ES izhaja, da je obseg obvezne obrazložitve odvisen od narave zadevnega akta.
Where a measure of general application is involved, the statement of reasons may be confined to indicating the general situation which led to its adoption, on the one hand, and the general objectives which it is intended to achieve, on the other.
Glede splo�nega akta se obrazložitev lahko omeji na navedbo, po eni strani, celotnega položaja, ki je privedel do njegovega sprejetja, in, po drugi strani, splo�nih ciljev, ki se sku�ajo doseči.
40Furthermore, the Court has repeatedly held that, if the contested measure clearly discloses the essential objective pursued by the institution, it would be exces-
40Nadalje je Sodi�če večkrat ugotovilo, da bi bilo preveč zahtevati posebno obrazložitev različnih tehničnih
In my view, Regulation No 1873/2003 should be declared invalid in its entirety as the limitations imposed by that regulation on the mode of administration of
1873/2003 razglasiti za nično v celoti, saj so omejitve, ki jih določa ta uredba glede načina dajanja progesterona, osrednji in torej neizogibni del te uredbe kot
39 — See point 37 above.
I-9131, točka 62.
38 — Article 4(1) of Directive 96/22 makes specific reference to Directive 81/851.
38 – Člen 4(1) Direktive 96/22 se izrecno sklicuje na Direktivo 81/851. Direktiva 81/851 je bila razveljavljena z Direktivo 2001/82.
Many of the provisions of Directive 81/851 were recast in Directive 2001/82.
Mnogo določb Direktive 81/851 je bilo v Direktivi 2001/81 spremenjenih.
CP-PHARMA sive to require a specific statement of reasons for the various technical choices made.
CP-PHARMA izbir, če izpodbijani akt podaja bistveni cilj, ki ga želijo doseči institucije.
41 of the use of that substance established in Directive 96/22 are observed. In my view, as the key recitals in the preamble to Regulation No 1873/2003 mentioned above, together with the remaining recitals, contain a coherent and sufficient description of the general situation which led to its adoption, the obligation to state reasons laid down in Article 253 EC has been satisfied.
41 skladen in zadosten opis splo�nega stanja, ki je vodilo k njenem sprejetju, torej je bila obveznost obrazložitve, določena v členu 253 ES, spo�tovana.
As is clear from the above, I consider that Regulation No 1873/2003 is contrary to Community law and should therefore be declared invalid in its entirety.
Kot izhaja iz zgoraj povedanega, menim, da je Uredba �t. 1873/2003 v nasprotju s pravom Skupnosti in jo je treba v celoti razglasiti za nično.
However, the eighth to the 11th recitals in the preamble to Regulation No 1873/2003 clearly indicate why the Commission considered it was necessary to impose limitations on the mode of administration of progesterone, despite its inclusion in Annex II to Regulation No 2377/90.
1873/2003 jasno določajo, zakaj je Komisija menila, da je bilo nujno treba določiti omejitve glede načina dajanja progesterona, čeprav je bil vključen v Prilogo II Uredbe �t. 2377/90.
It is clear from the recitals in the preamble to Regulation No 1873/2003, particularly the fifth and the eighth to the 10th recitals, that the purpose of limiting the mode of administration of progesterone to intravaginal use was to provide an additional safeguard, to avoid misuse of that substance, to those already provided by Directive 96/22.
1873/2003, zlasti iz pete, osme, devete in deste uvodne izjave, jasno izhaja, da je bil namen omejevanja načina dajanja progesterona na intravaginalno uporabo poleg tistih, ki jih je določila že Direktiva 96/22, zagotoviti dodatno za�čito in se tako izogniti zlorabi te snovi.
In that regard, the Commission specifically indicated in the eighth recital in the preamble to Regulation No 1873/2003 that it considered that the methods available to detect progesterone in animal tissues were incapable of controlling that the restrictions
Glede tega je Komisija v osmi uvodni izjavi Uredbe �t.1873/2003 posebej določila, da po njenem mnenju z metodami, s katerimi je v tkivih živali mogoče izslediti progesteron, ni mogoče nadzorovati, ali so omejitve uporabe te snovi, določene v Direktivi 96/22, spo�tovane. Menim, da ključne uvodne izjave Uredbe �t.
42 — It must be recalled that, according to settled caselaw, a judgment of the Court in proceedings for a preliminary ruling declaring a Community act to be invalid takes effect, like a judgment annulling an act, from the date on which the act entered into force.
42 – Treba je opomniti, da iz ustaljene sodne prakse izhaja, da sodba Sodi�ča v postopkih za predhodno odločanje, s katerimi se akt Skupnosti razglasi za ničnega, učinkuje kot sodba, ki akt razglasi za ničnega, od datuma, ko je akt začel veljati.
The Court may, however, limit in the judgment itself the temporal effects of a preliminary ruling declaring a Community regulation invalid, where that is justified by overriding considerations.
Sodi�če pa lahko v sodbi omeji časovne učinke predhodnega odločanja, tako da uredbo Skupnosti razglasi za nično, kjer to upravičujejo pomembni razlogi.
That power is inferred from an interpretation of Articles 230 EC, 231 EC and 234 EC, taken together, the reference for a preliminary ruling on the validity of an act and the action for annulment being the two mechanisms provided by the Treaty for reviewing the legality of legislation.
Ta pristojnost se je izvajala iz razlage členov 230 ES, 231 ES in 234 ES, obravnavanih skupaj, saj sta predlog za sprejetje predhodne odločbe glede veljavnosti akta in tožba za razglasitev ničnosti dva mehanizma, ki ju določa Pogodba za nadzor zakonitosti ureditve.
41 — United Kingdom v Council, cited in footnote 40, paragraph 26; Spain v Council, cited in footnote 40, paragraph 30; and Luxemburg v Parliament and Council, cited in footnote 40, paragraph 62.
41 – V opombi 40 navedene sodbe Združeno kraljestvo proti Svetu, točka 26, Španija proti Svetu, točka 30, in Luksemburg proti Parlamentu in Svetu, točka 62.
JUDGMENT OF THE COURT (First Chamber)
SODBA SODIŠČA (prvi senat) z dne 17. julija 2008 *
REFERENCE for a preliminary ruling under Article 234 EC from the Verwaltungsgericht Köln (Germany), made by decision of 24 October 2006, received at the Court on 2 November 2006, in the proceedings cp-Pharma Handels GmbH v
V zadevi C-448/06, katere predmet je predlog za sprejetje predhodne odločbe na podlagi člena 234 ES, ki ga je vložilo Verwaltungsgericht Köln (Nemčija) z odločbo z dne 24. oktobra 2006, ki je prispela na Sodi�če 2. novembra 2006, v postopku cp-Pharma Handels GmbH proti
2008 — CASE C-448/06
2008 – ZADEVA C-448/06 generalni pravobranilec: J.
Advocate General: J. Mazák, Registrar: J. Swedenborg, Administrator, having regard to the written procedure and further to the hearing on 18 October 2007, after considering the observations submitted on behalf of:
Swedenborg, administrator, na podlagi pisnega postopka in obravnave z dne 18. oktobra 2007, ob upo�tevanju stali�č, ki so jih predložili:
CP-PHARMA gives the following
CP-PHARMA izreka naslednjo
The reference was made in the course of proceedings between cp-Pharma Handels GmbH (‘cp-Pharma’) and Bundesrepublik Deutschland (Federal Republic of Germany) with regard to a decision of the competent German authority revoking the marketing authorisation for the medicinal product ‘progesterone for veterinary use’ in the form of a solution administered by intramuscular injection which had been granted to that company.
Ta predlog je bil vložen v okviru spora med cp-Pharma Handels GmbH (v nadaljevanju: družba cp-Pharma ) in Zvezno republiko Nemčijo glede odločbe pristojnega nem�kega organa o preklicu dovoljenja za to, da se daje v promet zdravilo, imenovano „progesteron za uporabo v veterini“, v obliki raztopine za intramuskularno aplikacijo (injekcijo), ki je bilo izdano tej družbi.
2008 — CASE C-448/06
2008 – ZADEVA C-448/06
The provisions concerning the establishment of maximum residue limits
Predpisi glede določanja najvi�jih mejnih vrednosti ostankov
— Regulation (EEC) No 2377/90
– Uredba (EGS) �t. 2377/90
1; ‘Regulation No 2377/90’), state as follows:
2377/90), v prvi in tretji uvodni izjavi določa:
‘… the use of veterinary medicinal products in foodproducing animals may result in the presence of residues of foodstuffs obtained from treated animals;
„ker se lahko zaradi uporabe zdravil za uporabo v veterinarski medicini pri živalih za proizvodnjo živil pojavijo ostanki v živilih, pridobljenih iz zdravljenih živali;
… in order to protect public health, maximum residue limits [‘MRLs’] must 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, in particular the
[…] ker je za za�čito javnega zdravja treba določiti najvi�je mejne vrednosti ostankov [v nadaljevanju: NMVO] v skladu s splo�no priznanimi načeli presoje varnosti, ob upo�tevanju drugih znanstvenih presoj varnosti zadevnih snovi, ki bi jih lahko
Codex Alimentarius or, where such substances are used for other purposes, by other scientific committees established within the Community’.
CP-PHARMA opravljale mednarodne organizacije, zlasti Codex Alimentarius ali, če se tak�ne snovi uporabljajo za druge namene, drugi znanstveni odbori s sedežem v Skupnosti“.
Article 1(1)(b) of that regulation defines an MRL as the maximum concentration of residue resulting from the use of a veterinary medicinal product which may be accepted by the Community to be legally permitted or recognised as acceptable in or on a food.
Člen 1(1)(b) te uredbe opredeljuje NMVO kot najvi�jo mejno vrednost ostankov po uporabi zdravila za uporabo v veterinarski medicini, ki jo Skupnost lahko sprejme kot zakonsko dovoljeno ali priznano kot sprejemljivo v ali na živilu.
Articles 2 to 5 of Regulation No 2377/90 provide for the classification in four separate annexes of pharmacologically active substances used in veterinary medicinal products for foodproducing animals.
V členih od 2 do 5 Uredbe �t. 2377/90 je predvidena uvrstitev farmakolo�ko aktivnih snovi, ki se uporabljajo v zdravilih za uporabo v veterinarski medicini pri živalih za proizvodnjo živil, v �tiri različne priloge.
Those substances are to be classified in Annex I if the MRLs have been established (Article 2 of the regulation), in Annex II where, ‘following an evaluation …, it appears that it is not necessary for the protection of public health to establish [an MRL]’ (Article 3 of that regulation) and in Annex IV where it appears that an MRL cannot be established because the residues, whatever their limit, present a hazard for the health of the consumer (first paragraph of Article 5 of the regulation).
Te snovi je treba uvrstiti v prilogo I, če so bile NMVO določene (člen 2 te uredbe), v prilogo II, če se „po presoji […] pokaže, da za za�čito javnega zdravja ni treba določiti [NMVO]“ (člen 3 te uredbe) in v prilogo IV, kadar se zdi, da NMVO ni mogoče določiti, ker ostanki, ki se v kakr�ni koli količini pojavijo v živilih živalskega izvora, pomenijo tveganje za zdravje potro�nika (člen 5, prvi odstavek, te uredbe).
Finally, under the first paragraph of Article 4 thereof, a provisional MRL may be established for a substance used on the date of entry into force of the regulation, ‘provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a hazard for the health of the consumer’.
Nazadnje se lahko v skladu s členom 4, prvi odstavek, te uredbe določi začasna NMVO za snov, ki se uporablja ob začetku veljavnosti te uredbe, „če ni nobenih razlogov, na podlagi katerih bi lahko sklepali, da ostanki zadevne snovi v predlagani količini predstavljajo tveganje za zdravje potro�nikov“.
Substances for which provisional MRLs have been established are dealt with in Annex III to Regulation No 2377/90.
Snovi, za katere so bile določene začasne NMVO, so navedene v prilogi III k Uredbi �t. 2377/90.
1)], hereinafter referred to as “the Agency”’.
1)], v nadaljevanju: Agencija, predloži vloga za določitev [NMVO]“.
Article 7 of Regulation No 2377/90 provides:
Člen 7 Uredbe �t. 2377/90 določa:
The Committee for Veterinary Medicinal Products referred to in Article 27 of Regulation (EEC) No 2309/93 (hereinafter “the [CVMP]”) shall be responsible for formulating the Agency’s opinion on the classification of substances referred to in Annex I, II, III or IV to this Regulation.
Odbor za zdravila za uporabo v veterinarski medicini iz člena 27 Uredbe Sveta (EGS) �t. 2309/93 (v nadaljevanju: CMV) je pristojen za oblikovanje mnenja Agencije o razvr�čanju snovi iz prilog I, II, III ali IV k tej uredbi.
The Agency shall forward the definitive opinion of the [CVMP] within 30 days of its adoption both to the Commission and to the applicant.
Agencija posreduje Komisiji in vlagatelju dokončno mnenje [CMV] v 30 dneh od njegovega sprejetja.
The opinion shall be accompanied by a report describing the safety evaluation of the substance by the Committee, which shall give the grounds for its conclusions.
Mnenju je dodano poročilo, v katerem je opisana ocena varnosti snovi [CMV], ki da razloge za svoj sklep.
The Commission shall prepare draft measures taking account of Community legislation …’
Komisija pripravi osnutek ukrepov, ki upo�tevajo zakonodajo Skupnosti […]“
Under Article 8(1) of Regulation No 2377/90, ‘[t]he Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products’.
V skladu s členom 8(1) Uredbe �t. 2377/90 „Komisiji pomaga Stalni odbor za zdravila za uporabo v veterinarski medicini“.
Article 14 of Regulation No 2377/90, in its original version, provided:
Člen 14 Uredbe �t. 2377/90 je v prvotni različici določal:
‘With effect from 1 January 1997, the administration to foodproducing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annex I, II or III shall be prohibited within the Community …’
„Od 1. januarja 1997 se za živali za proizvodnjo živil v Skupnosti prepove uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo farmakolo�ko aktivne snovi, ki niso navedene v prilogi I, II ali III […]“
In the version of Regulation No 2377/90 applicable to the dispute in the main proceedings, the date 1 January 1997 was replaced by 1 January 2000 for the majority of substances (including progesterone) whose use was authorised at 7 March 1997 and for which applications for establishment of an MRL had been filed with the Commission or the Agency before 1 January 1996.
V različici Uredbe �t. 2377/90, ki velja za spor v glavni stvari, se je za večino snovi (vključno s progesteronom), katerih uporaba je bila dovoljena s 7. marcem 1997 in za katere so bile vloge za določitev NMVO pri Komisiji ali Agenciji vložene pred 1. januarjem 1996, datum 1. januar 1997 nadomestil s 1. januarjem 2000.
— Regulation No 1873/2003
– Uredba �t. 1873/2003
The inclusion of that pharmacologically active substance is accompanied by the following footnote:
Vključitev te farmakolo�ko aktivne snovi spremlja opomba spodaj na naslednji strani:
‘Only for intravaginal therapeutic or zootechnical use and in accordance with [Council] Directive 96/22/EC [of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ 1996 L 125, p. 3)]’.
„Le za intravaginalno terapevtsko ali zootehnično uporabo in v skladu z določbami Direktive [Sveta] 96/22/ES [z dne 29. aprila 1996 o prepovedi uporabe v živinoreji določenih snovi, ki imajo hormonalno ali tirostatično delovanje, in beta-agonistov ter o razveljavitvi direktiv 81/602/EGS, 88/146/EGS in 88/299/EGS (UL L 125, str. 3)]“.
The sixth, eighth and tenth recitals in the preamble to Regulation No 1873/2003 are worded as follows:
Šesta, osma in deseta uvodna izjava Uredbe �t.
The SCVPH [Scientific Committee on Veterinary Measures relating to Public Health] repeatedly confirmed that the use of hormones for growth promotion purposes in meat production poses a potential health risk to consumers due to their intrinsic pharmacological and toxicological properties and epidemiological findings.
„(6) SCVPH [znanstveni odbor za veterinarske javnozdravstvene ukrepe] je večkrat potrdil, da uporaba hormonov za pospe�evanje rasti pri proizvodnji mesa pomeni možno tveganje za zdravje potro�nikov zaradi njihovih vsebovanih farmakolo�kih in toksikolo�kih lastnosti ter na podlagi epidemiolo�kih ugotovitev.
However, at present the data available on progesterone are insufficient to make any quantitative estimate of the risk arising from the exposure to residues in meat and meat products originating from treated animals.
Vendar pa trenutno podatki, ki so na voljo o progesteronu, ne zado�čajo za kakr�no koli kvantitativno oceno tveganja zaradi izpostavljenosti ostankom v mesu in mesnih izdelkih, ki so pridobljeni iz zdravljenih živali.
No threshold levels can be defined for progesterone in this regard.
V zvezi s tem za progesteron ni mogoče določiti nobenih pragov.
Animals also naturally produce progesterone.
Živali tudi naravno proizvajajo progesteron.
The level of endogenous secretion of progesterone in the animals is variable, depending notably on gender, age, breed and sexual cycle.
Raven endogene sekrecije progesterona pri živalih je različna in je odvisna predvsem od spola, starosti, pasme in spolnega ciklusa.
Validated methods are available to detect progesterone in animal tissues.
Na voljo so validirane metode za odkrivanje progesterona v živalskih tkivih.
However, these methods cannot distinguish between naturally occurring hormones and residues of progesterone as a means of controlling that the restrictions of use established in Directive 96/22/EC are observed.
Vendar pa s temi metodami ni mogoče razlikovati med naravno ustvarjenimi hormoni in ostanki progesterona ter jih uporabljati za nadzorovanje tega, ali se spo�tujejo omejitve uporabe, določene v Direktivi 96/22/ES.
The Commission considers that safeguards as to the possibility of misuse of veterinary medicinal products containing progesterone are necessary.
(10) Komisija meni, da so potrebni nadzorni ukrepi glede možnosti zlorabe zdravil za uporabo v veterinarski medicini, ki vsebujejo progesteron.
Restricting the terms of the use of progesterone to administration only via the intravaginal route in female animals of bovine, ovine, caprine and equine species provides this additional safeguard needed to avoid misuse as the relevant veterinary medicinal products cannot, due to their specific presentation, be realistically used for prohibited purposes.
Omejevanje pogojev uporabe progesterona samo na intravaginalno uporabo pri samicah goveda, ovac, koz in kopitarjev določa ta dodatni za�čitni ukrep, ki je potreben, da bi se izognili zlorabi, ker zadevnih zdravil za uporabo v veterinarski medicini zaradi njihove specifične oblike uporabe realno ni mogoče uporabljati za prepovedane namene. Zato je primerno, da se progesteron vnese v Prilogo II k Uredbi Sveta […] �t.
The other relevant provisions
Drugi upo�tevni predpisi
Directive 96/22, as amended by Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 (OJ 2003 L 262, p.
Direktiva 96/22, kot je bila spremenjena z Direktivo Evropskega parlamenta in Sveta 2003/74/ES z dne 22. septembra 2003 (UL L 262, str.
17; ‘Directive 96/22’), which is the version relevant to the dispute in the main proceedings, provides that Member States are to prohibit the administration to a farm animal of hormonal substances having a gestagenic effect, which includes progesterone.
17, v nadaljevanju: Direktiva 96/22), ki je različica, ki velja za spor v postopku v glavni stvari, določa, da države članice prepovejo dajanje hormonskih snovi z gestagenim delovanjem, med katere se uvr�ča progesteron, farmskim živalim.