natgillin/translations-raw huggingface dataset:
Second, pursuant to the second paragraph of Article 222 EC, it is the duty of the Advocate General, acting with complete impartiality and independence, to make, in open court, reasoned submissions on cases which, in accordance with the Statute of the Court of Justice, require the Advocate General’s involvement.
Poleg tega je na podlagi člena 222, drugi odstavek, ES dolžnost generalnega pravobranilca, da popolnoma nepristransko in neodvisno javno predstavi obrazložene sklepne predloge o zadevah, pri katerih je v skladu s Statutom Sodi�ča zahtevano njegovo sodelovanje.
In carrying out that task, the Advocate General may, where appropriate, analyse a reference for a preliminary ruling by placing it in a context broader than that strictly defined by the national court or the parties to the main proceedings.
Pri opravljanju te naloge lahko predlog za sprejetje predhodne odločbe po potrebi analizira v �ir�em kontekstu in ne točno takem, kakr�nega so opredelili predložitveno sodi�če ali stranke v postopku v glavni stvari.
Given that the Court is not bound either by the Advocate General’s Opinion or by the reasoning which led to that view to be formed, it is not necessary to reopen the oral procedure, pursuant to Article 61 of the Rules of Procedure, every time the Advocate General raises a point of law that has not been debated by the parties.
Ker Sodi�ča ne vežejo ne sklepni predlogi generalnega pravobranilca ne obrazložitev, ki ga privede do njih, ni nujno ponovno odpirati ustnega postopka v skladu s členom 61 Poslovnika vsakič, ko generalni pravobranilec sproži pravno vpra�anje, o katerem se stranki nista izrekli.
In the present case, since the Court considers that it has sufficient information for a ruling and the case does not have to be dealt with on the basis of arguments which have not been debated between the parties, there is no need to allow the request for the reopening of the oral procedure.
Ker je Sodi�če v tem primeru menilo, da je pridobilo dovolj podatkov za presojanje, in ker zadeve ni treba obravnavati na podlagi trditev, o katerih se stranki nista izrekli, je odločilo, da ni treba ugoditi predlogu za ponovno odprtje ustnega postopka.
By its question, the national court asks, essentially, whether Article 4(1) of Directive 2002/37 must be interpreted as not requiring Member States to terminate, before
Predložitveno sodi�če s svojim vpra�anjem v bistvu spra�uje, ali je treba člen 4(1) Direktive 2002/37 razlagati tako, da od držav članic ne zahteva preklica obstoječe
1 September 2003, an existing authorisation of a plant protection product containing ethofumesate on the ground that, for the purposes of the review of that authorisation, the holder of the authorisation does not hold, or have access to, an Annex II dossier.
2008 – ZADEVA C-361/06 registracije fitofarmacevtskega sredstva, ki vsebuje etofumesat, pred 1. septembrom 2003, če imetnik registracije za potrebe pregleda te registracije nima ali nima dostopa do dokumentacije iz Priloge II.
Feinchemie and Bayer — as well as the Governments of the Netherlands and Belgium, and the Commission — maintain that the question referred should be answered in the negative.
Družbi Feinchemie in Bayer, nizozemska in belgijska vlada ter Komisija predlagajo, naj se na vpra�anje odgovori nikalno.
They submit that the holders of existing previous authorisations must be in possession of an Annex II dossier from the moment the active substance is included in Annex I to Directive 91/414.
Zatrjujejo, da morajo imeti imetniki starej�ih obstoječih registracij dokumentacijo iz Priloge II od uvrstitve aktivne snovi v Prilogo I k Direktivi 91/414.
Even though Article 4(1) of Directive 2002/37 does not so expressly provide, the obligation imposed on Member States to terminate, before 1 September 2003, existing previous authorisations for plant protection products containing ethofumesate flows from the purpose, the general scheme and the rules of Directive 91/414.
Čeprav člen 4(1) Direktive 2002/37 tega ne določa izrecno, naj bi obveznost držav članic, da do 1. septembra 2003 prekličejo starej�e obstoječe registracije sredstev, ki vsebujejo etofumesat, izhajala iz namena, splo�ne sistematike in pravil Direktive 91/414.
The Commission submits moreover that the deadline laid down in Article 4(1) of Directive 2002/37 relates to the submission of an Annex II dossier, whereas the deadline laid down in Article 4(2) of that directive relates to the re-evaluation of a plant protection product on the basis of an Annex III dossier, in so far as compiling an Annex III dossier requires more time than compiling an Annex II dossier.
Komisija poleg tega meni, da velja rok iz člena 4(1) Direktive 2002/37 za predložitev dokumentacije iz Priloge II, medtem ko naj bi rok iz odstavka 2 tega člena veljal za pregled fitofarmacevtskega sredsteva na podlagi dokumentacije iz Priloge III, če bi priprava slednje dokumentacije zahtevala več časa od prve.
Since Article 13(3)(d) of Directive 91/414 generally precludes the Member States from using information submitted in support of an application for inclusion of an active substance in Annex I to the directive — that is to say, the information referred to in Annex II to the directive — for the benefit of other applicants for a period of five years from the date on which the decision to include the active substance concerned took effect, those Member States must check that the holders of existing authorisations also hold, or have access to, an Annex II dossier.
Ker naj bi člen 13(3)(d) Direktive 91/414 državam članicam načeloma prepovedoval, da v obdobju petih let od dne, ko je začela veljati odločitev o uvrstitvi zadevne aktivne snovi, v korist drugih oseb uporabljajo podatke, predložene v utemeljitev zahtevka za uvrstitev aktivne snovi v Prilogo I k tej direktivi, namreč podatke iz Priloge II k tej direktivi, bi se morale te države članice prepričati, da imajo tudi imetniki obstoječih registracij dokumentacijo iz Priloge II oziroma dostop do take dokumentacije.
Accordingly, Article 13(6) of Directive 91/414 authorises the Member States to continue to apply previous national rules concerning data requirements so long as the substances concerned are not included in Annex I to that directive.
Člen 13(6) Direktive 91/414 naj bi v tem smislu države članice poobla�čal, da �e naprej uporabljajo predhodne nacionalne predpise glede zahtevanih podatkov, dokler se take snovi ne uvrsti v Prilogo I k tej direktivi.
It follows that, as soon as an active substance is included in that annex, the transitional measures under that directive cease to be applicable to the active substance in question, or to plant protection products containing that active substance, and the rules laid down in Article 13(1) then apply.
Iz tega naj bi izhajalo, da z uvrstitvijo aktivne snovi v to prilogo za zadevno aktivno snov in za fitofarmacevtska sredstva, ki jo vsebujejo, prenehajo veljati prehodne določbe navedene direktive, za zadnjenavedena sredstva pa začne veljati ureditev iz odstavka 1 tega člena.
Specifically, applications for authorisation of a plant protection product must be accompanied by an Annex II and an Annex III dossier.
Zlasti pa bi morala biti zahtevkom za registracijo fitofarmacevtskega sredstva priložena dokumentacija, ki izpolnjuje pogoje iz Priloge II in Priloge III.
Feinchemie and Bayer and the Commission submit that their interpretation of Directives 91/414 and 2002/37 is confirmed by the wording of subsequent directives concerning the inclusion of an active substance in Annex I to Directive 91/414, such as Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414 (OJ 2005 L 241, p.
Družbi Feinchemie in Bayer ter Komisija zatrjujejo, da njihovo razlago direktiv 91/414 in 2002/37 potrjujejo besedila novej�ih direktiv o uvrstitvi aktivnih snovi v Prilogo I k Direktivi 91/414, na primer Direktive Komisije 2005/53/ES z dne 16. septembra 2005 o spremembi Direktive Sveta 91/414/EGS (UL L 241, str.
51), which states in the 11th recital in the preamble thereto:
51), katere uvodna izjava 11 določa:
‘The experience gained from previous inclusions in Annex I to Directive 91/414 of active substances assessed in the framework of Regulation No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
„Izku�nje iz preteklih vključitev aktivnih snovi, ocenjenih v okviru Uredbe (EGS) �t. 3600/92, v Prilogo I k Direktivi 91/414/EGS, kažejo, da lahko pri tolmačenju dolžnosti imetnikov obstoječih dovoljenj nastopijo težave v zvezi z dostopom do podatkov.
In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive…’.
Da bi se izognili nadaljnjim težavam, se zato zdi primerno, da se razjasnijo dolžnosti držav članic, zlasti dolžnost preverjanja, da ima imetnik registracije dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi. […]“
Agrichem, for its part, contends that the question referred should be answered in the affirmative.
Družba Agrichem predlaga, naj se na zastavljeno vpra�anje odgovori pritrdilno.
The clear provisions of Article 4(1) of Directive 2002/37 show that, at the review stage, authorisations of plant protection products containing ethofumesate only have to fulfil the conditions for that active substance laid down in Annex I to Directive 91/414.
Iz jasnih določb člena 4(1) Direktive 2002/37 naj bi namreč izhajalo, da morajo registracije fitofarmacevtskih sredstev, ki vsebujejo etofumesat, ob pregledu izpolnjevati zgolj pogoje, ki so za to aktivno snov določeni v Prilogi I k Direktivi 91/414.
The longer period allowed under Article 4(2) of Direct - ive 2002/37 is justified by the time required for the compilation of an Annex III dossier.
Dalj�i rok iz člena 4(2) Direktive 2002/37 naj bi bil upravičen zaradi časa, ki je potreben za pripravo dokumentacije, ki je v skladu s Prilogo III. Roka iz člena 4(1)
2008 — CASE C-361/06 be considered to be sufficient for the compilation of an Annex II or an Annex III dossier.
Direktive 2002/37 zato ni mogoče �teti kot zadostnega za pripravo dokumentacije, ki bo v skladu s Prilogo II ali Prilogo III.
Agrichem also contends that, if it were necessary to submit such a complete dossier already at the stage of the review, in the light of Annex I to Directive 91/414, of authorisations to place on the market plant protection products containing ethofumesate as an active substance, there would be no difference between the two types of examination provided for, respectively, in paragraphs 1 and 2 of Article 4 of Directive 2002/37.
Agrichem poleg tega zatrjuje, da če bi bilo treba popolno dokumentacijo predložiti že ob pregledu registracij za dajanje fitofarmacevtskih sredstev, ki vsebujejo „etofumesat“ kot aktivno snov, v promet – opravljenem v zvezi s Prilogo I k Direktivi 91/414 – ne bi bilo nobene razlike med dvema vrstama pregledov, določenima v odstavkih 1 oziroma 2 člena 4 Direktive 2002/37.
In addition, that interpretation of Article 4(1) cannot be called into question by the provisions of Directive 91/414, given that, in relation to Directive 91/414, Directive 2002/37 is a lex specialis.
Poleg tega naj te razlage navedenega člena 4(1) ne bi bilo mogoče izpodbijati na podlagi določb Direktive 91/414, ker naj bi bila Direktiva 2002/37 v razmerju do nje lex specialis.
Findings of the Court
Odgovor Sodišča
It should be recalled, first, that, under Article 6 of Directive 91/414, it is the Commission, assisted by the Standing Committee on the Food Chain and Animal Health, that has the power to include an active substance in Annex I to that directive.
Uvodoma je treba opozoriti, da je na podlagi člena 6 Direktive 91/414 za uvr�čanje aktivnih snovi v Prilogo I k tej direktivi pristojna Komisija, ki ji pomaga Stalni odbor za prehranjevalno verigo in zdravje živali.
The Commission’s decision takes the form of a directive, like Directive 2002/37, Article 1 of which includes the active substance ethofumesate in Annex I to Directive 91/414.
Njena odločitev ima obliko direktive o uvrstitvi, kakr�na je Direktiva 2002/37, katere člen 1 določa, da se v Prilogo I uvrsti aktivna snov „etofumesat“.
Having regard to that inclusion, Article 4(1) of Directive 2002/37 requires Member States, first, to review authorisations previously granted for each plant protection product containing ethofumesate, in order to ensure that the conditions relating to that active substance, as set out in Annex I to Directive 91/414, are complied with and, second, to amend or, if necessary, to withdraw those authorisations, in accordance with that directive, before 1 September 2003.
V zvezi s to uvrstitvijo člen 4(1) Direktive 2002/37 državam članicam nalaga, naj, prvič, pregledajo prej izdane registracije za vsako fitofarmacevtsko sredstvo, ki vsebuje etofumesat, in se s tem prepričajo, da izpolnjujejo pogoje v zvezi s to aktivno snovjo iz Priloge I k Direktivi 91/414/EGS, ter, drugič, v skladu s slednjo direktivo spremenijo ali po potrebi prekličejo navedene registracije do 1. septembra 2003.
Article 4(2) of Directive 2002/37, on the other hand, provides that each plant protection product containing ethofumesate — whether as the only active substance or as one of several active substances all of which are listed in Annex I to Directive 91/414 by 1 March 2003 — is to be re-eval-uated by the Member States in accordance with the uniform principles provided for in Annex IV to that directive, on the basis of an Annex III dossier.
Vendar pa člen 4(2) Direktive 2002/37 določa, da države članice za vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje etofumesat kot edino aktivno snov ali kot eno od več aktivnih snovi, ki so vse bile vključene v Prilogo I k Direktivi 91/414, do 1. marca 2003 ponovno ocenijo to sredstvo v skladu z enotnimi načeli iz Priloge VI k tej direktivi na osnovi dokumentacije iz Priloge III.
Thus, there is nothing in the wording of Article 4(1) of Directive 2002/37 to suggest that the holders of existing authorisations must, for the purposes of the review of those authorisations, hold, or have access to, an Annex II dossier.
Iz besedila člena 4(1) Direktive 2002/37 torej nikakor ne izhaja, da morajo imetniki obstoječih registracij za namen postopka pregleda teh registracij imeti dokumentacijo iz Priloge II oziroma dostop do nje.
That interpretation is supported by the eighth recital in the preamble to Directive 2002/37.
To razlago potrjuje uvodna izjava 8 Direktive 2002/37.
According to that recital, following the inclusion of ethofumesate in Annex I to Directive 91/414, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414 as regards plant protection products containing that active substance, and in particular, to review existing authorisations in accordance with the provisions of that directive in order to ensure that the conditions regarding ethofumesate set out in Annex I to that directive are satisfied.
V skladu s to uvodno izjavo je treba po vključitvi etofumesata v Prilogo I k Direktivi 91/414 državam članicam omogočiti določeno obdobje za izvajanje določb Direktive 91/414 v zvezi s sredstvi, ki vsebujejo to aktivno snov, in zlasti za ponovni pregled obstoječih registracij v skladu z določbami zadnjenavedene direktive, da zagotovijo, da so izpolnjeni pogoji v zvezi z etofumesatom iz Priloge I k tej direktivi.
It is also clear from that recital that the holders of such authorisations should be allowed a longer period for the submission of an Annex II and an Annex III dossier for each plant protection product, and for the re-evaluation of that product in accordance with the uniform principles laid down in Annex VI to Directive 91/414.
Iz te uvodne izjave izhaja tudi, da je treba zagotoviti dalj�e obdobje, v katerem imetniki obstoječih registracij za vsako fitofarmacevtsko sredstvo predložijo dokumentacijo iz Priloge II in dokumentacijo iz Priloge III ter v katerem se pripravek ponovno oceni v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414.
Accordingly, it does not seem that Article 4(1) of Directive 2002/37 must be interpreted as requiring Member States to terminate, before 1 September 2003, an existing authorisation of a plant protection product containing ethofumesate on the ground that the authorisation holder does not hold, or have access to, an Annex II dossier.
Ne zdi se torej, da je treba člen 4(1) Direktive 2002/37 razlagati tako, da od držav članic zahteva preklic registracije fitofarmacevtskega sredstva, ki vsebuje etofumesat, pred 1. septembrom 2003, če imetnik registracije nima dokumentacije iz Priloge II oziroma dostopa do nje.
In order to respond to the arguments raised by Feinchemie and Bayer, the Governments of the Netherlands and Belgium and the Commission — according to which such a literal interpretation conflicts with the provisions concerning data protection laid down in Directive 91/414, including Article 13(3) of that directive, and that, therefore, Article 4(1) of Directive 2002/37 must be read in the light of Directive 91/414 — it must be stated from the outset that Directive 2002/37 pursues three principal objectives: (i) to include ethofumesate in Annex I to Directive 91/414; (ii) to ensure that Member States check whether the existing authorisations for plant
Da bi lahko odgovorili na trditev družb Feinchemie in Bayer, nizozemske in belgijske vlade ter Komisije – ki menijo, da taka dobesedna razlaga nasprotuje določbam Direktive 91/414 o varovanju podatkov, in sicer členu 13(3), ter da je treba zato člen 4(1) Direktive 2002/37 razlagati glede na Direktivo 91/414 –, je treba najprej natančneje opredeliti, da Direktiva 2002/37 zasleduje tri temeljne cilje, in sicer, prvič, uvrstitev etofumesata v Prilogo I k Direktivi 91/414, drugič, zagotovitev, da države članice pregledajo, ali obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo
2008 — CASE C-361/06 protection products containing that active substance comply with the conditions relating to ethofumesate set out in that Annex and, if necessary, amend or withdraw those authorisations before 1 September 2003; and (iii) to ensure that Member States re-evaluate those products in accordance with the uniform principles laid down in Annex VI to Directive 91/414, on the basis of an Annex III dossier.
2008 – ZADEVA C-361/06 to aktivno snov, izpolnjujejo pogoje iz navedene priloge, ki se nana�ajo nanjo, in do 1. septembra 2003 te registracije po potrebi spremenijo ali prekličejo, ter tretjič, zagotovitev, da države članice na podlagi dokumentacije iz Priloge III navedena sredstva ponovno ocenijo v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414.
It must also be stated that, where an implementing directive requires interpretation, that interpretation must, as far as possible, be consistent with the provisions of the basic directive (see, by analogy, Case C-90/92 Dr Tretter [1993] ECR I-3569, paragraph 11).
Opozoriti je treba tudi, da mora biti, če izvedbena direktiva zahteva razlago, ta kolikor mogoče skladna z določbami osnovne direktive (po analogiji glej sodbo z dne 24. junija 1993 v zadevi Dr Tretter, C-90/92, Recueil, str. I-3569, točka 11).
In addition, a provision must be interpreted, as far as possible, in such a way as not to affect its validity (Case C-403/99 Italy v Commission [2001] ECR I-6883, paragraphs 28 and 37).
Poleg tega je treba določbo, kolikor je to mogoče, razlagati tako, da se ne zbuja dvoma o njeni veljavnosti (sodba z dne 4. oktobra 2001 v zadevi Italija proti Komisiji, C-403/99, Recueil, str. I-6883, točki 28 in 37).
However, although, by not expressly requiring Member States to check that the holders of previous authorisations have access to an Annex II dossier, Article 4(1) of Directive 2002/37 has the effect of curtailing the period during which data is protected pursuant to Article 13(3)(d) of Directive 91/414, that situation arises as a direct result of the way in which Article 4(1) of Directive 2002/37 is drafted.
Čeprav je zaradi člena 4(1) Direktive 2002/37, ki od držav članic ne zahteva, da preverjajo, ali imajo imetniki starej�ih registracij dostop do dokumentacije iz Priloge II, skraj�an čas varovanja podatkov iz člena 13(3)(d) Direktive 91/414, ta položaj izhaja neposredno iz besedila prve določbe.
Given that the wording of Article 4(1) of Directive 2002/37 is clear and unambiguous, the interpretation according to which the holder of an existing authorisation is not required, under that provision, to submit an Annex II dossier during the review phase is the only interpretation that is compatible with the principle of legal certainty, in accordance with which Community legislation must enable those concerned to acquaint themselves with the precise extent of the obligations it imposes upon them (see Case C-161/06 Skoma-Lux [2007] ECR I-10841, paragraphs 36 and 38).
Ker je besedilo člena 4(1) Direktive 2002/37 jasno in enopomensko, je z načelom pravne varnosti, ki zahteva, da zakonodaja Skupnosti zainteresiranim osebam omogoča natančno seznanitev z obsegom obveznosti, ki jim jih nalaga, skladna le razlaga, v skladu s katero imetniku obstoječe registracije na podlagi te določbe ob pregledu ni treba predložiti dokumentacije iz Priloge II (glej sodbo z dne 11. decembra 2007 v zadevi Skoma-Lux, C-161/06, ZOdl., str. I-10841, točki 36 in 38).
It must also be stated that Article 4(2) of Directive 2002/37 provides that Mem- ber States are to check, on the basis of an Annex III dossier, whether the plant protection products containing ethofumesate satisfy the conditions set out in Article 4(1)(b) to (e) of Directive 91/414 and then, if necessary, to amend or withdraw, for each plant protection product concerned, the authorisation granted previously. Thus, that
Poleg tega je treba poudariti, da člen 4(2) Direktive 2002/37 določa, da države članice na podlagi dokumentacije iz Priloge III preverjajo zlasti, ali fitofarmacevtska sredstva, ki vsebujejo etofumesat, izpolnjujejo pogoje iz člena 4(1), od (b) do (e), Direktive 91/414 in za vsako zadevno fitofarmacevtsko sredstvo po potrebi spremenijo ali
The interpretation of Article 4(1) of Directive 2002/37 cannot therefore be called into question by an interpretation of Directive 91/414 according to which the conditions of the review provided for in that provision would be stricter.
Razlage člena 4(1) Direktive 2002/37 torej ni mogoče ovreči z razlago Direktive 91/414, v skladu s katero bi bili pogoji pregleda, ki jih ureja ta določba, strožji.
As regards the argument, submitted by Feinchemie and Bayer and by the Commission, based on the interpretation of Article 4(1) of Directive 2002/37 in the light of subsequent directives — such as Directive 2005/53 — relating to the inclusion of various active substances in Annex I to Directive 91/414, it must be held, first, that the interpretation of Directive 2002/37 cannot depend on the subsequent adoption of similar measures and, second, that the last sentence of the 11th recital in the preamble to Directive 2005/53 states specifically that, as compared with the directives already adopted for the purposes of amending Annex I to Directive 91/414, Directive 2005/53 does not impose any new obligations on Member States or on the holders of authorisations.
V zvezi s trditvijo, ki jo družbi Feinchemie in Bayer ter Komisija izpeljujejo iz razlage člena 4(1) Direktive 2002/37 glede na poznej�e direktive o uvrstitvi različnih aktivnih snovi v Prilogo I k Direktivi 91/414, med njimi Direktivo 2005/53, je treba ugotoviti, da razlaga Direktive 2002/37 ne sme biti odvisna od poznej�ega sprejetja podobnih ukrepov, in da zadnji stavek uvodne izjave 11 Direktive 2005/53 določa prav to, namreč da ta direktiva v primerjavi z dotlej sprejetimi direktivami o spremembah Priloge I državam članicam ali imetnikom registracij ne nalaga nobenih dodatnih obveznosti.