natgillin/translations-raw huggingface dataset:
I shall henceforth refer to such dossiers as Annex II or Annex III dossiers.
Zato bom tako dokumentacijo imenovala kot dokumentacijo iz Priloge II oziroma dokumentacijo iz Priloge III.
10 — I have retranslated from the French text of Article 13(3)(d).
10 – Iz francoskega besedila sem ponovno prevedla člen 13(3)(d).
The original version of the English text was plainly wrong.
Izvirna različica angle�kega besedila je bila očitno nepravilna. Preoblikovana je bila v popravku (UL 1992, L 170, str. 40).
Article 13(3)(c) also restricts the use of this information.
Člen 13(3)(c) med drugim omejuje tudi uporabo teh podatkov.
Article 13(3)(d) prohibits Member States from making use of the information referred to in Annex II for the benefit of other applicants without consent for five years from the date of the decision following receipt of
Člen 13(3)(d) državam članicam prepoveduje uporabo podatkov iz Priloge II v dobro drugih vlagateljev brez soglasja za obdobje petih let od datuma odločitve po
Those active ethofumesate. 14
Priloga VI 11določa enotna načela za oceno fitofarmacevtskih sredstev.
Annex VI 11lays down uniform principles for the evaluation of plant protection products.
Med te aktivne snovi spada tudi etofumesat. 14
Article 4(1) of Regulation No 3600/92 lays down the procedure to be followed by the producer 15of an active substance referred to in Annex I thereto wishing to secure its inclusion in Annex I to Directive 91/414.
Člen 4(1) Uredbe �t. 3600/92 določa postopek, ki ga mora upo�tevati proizvajalec 15aktivne snovi iz Priloge I, ki želi zagotoviti njeno vključitev v Prilogo I k Direktivi 91/414.
The period of 12 years referred to in Article 8(2) was extended until 31 December 2006 for active substances assessed in the framework of the first stage of the Commission’s programme for examining such substances. 12
Dvanajstletno obdobje iz člena 8(2) je bilo za aktivne snovi, ki se ocenjujejo v okviru prve faze delovnega programa Komisije za ocenjevanje takih snovi, podalj�ano do 31. decembra 2005. 12
Regulation No 3600/92
Uredba št. 3600/92
That procedure is initiated by the producer’s notifying the Commission.
Ta postopek se začne z zahtevkom proizvajalca pri Komisiji. Proizvajalca, ki v skladu s členom 4(1) Uredbe �t.
I shall refer to a producer notifying the Commission in accordance with Article 4(1) of Regulation No 3600/92 as ‘a notifier’.
3600/92 vloži zahtevo pri Komisiji, bom imenovala „prijavitelja“.
Regulation No 3600/92 13lays down the procedure for the inclusion in Annex I to Directive 91/414 of certain active substances contained in plant protection products covered by existing authorisations, referred to in Article 8(2) of that directive.
Uredba �t. 3600/92 13določa postopek vključitve v Prilogo I k Direktivi 91/414 nekaterih aktivnih snovi, ki jih vsebujejo fitofarmacevtska sredstva, ki so že registrirana v skladu s členom 8(2) navedene direktive.
11 — Inserted by Council Directive 94/43/EC of 27 July 1994 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ 1994 L 227, p. 31).
11 – Vključena z Direktivo Sveta 94/43/ES z dne 27. julija 1994 o določitvi Priloge VI k Direktivi 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet (UL L 227, str. 31).
Article 6 of Regulation No 3600/92 requires the notifiers, individually or collectively, to send to the designated authority, within a prescribed time-limit, for any given active substance (a) a summary dossier containing summary information for each point of Annexes II and III to Directive 91/414 and (b) a complete dossier containing complete information for each point of those Annexes.
Člen 6 Uredbe �t. 3600/92 določa, da morajo prijavitelji posamezno ali skupaj v predpisanemu roku poslati imenovanemu organu za vsako aktivno snov (a) povzetek dokumentacije, ki vsebuje jedrnate informacije za vsako točko prilog II in III k Direktivi 91/414, in (b) popolno dokumentacijo s popolnimi informacijami za vsako točko teh prilog.
12 — Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances (OJ 2002 L 319, p.
12 – Uredba Komisije (ES) �t. 2076/2002 z dne 20. novembra 2002 o podalj�anju roka iz člena 8(2) Direktive Sveta 91/414/EGS in o nevključitvi nekaterih aktivnih snovi v Prilogo I k navedeni direktivi ter o odvzemu registracij za fitofarmacevtska sredstva, ki vsebujejo te snovi (UL L 319, str.
3) as amended by Commission Regulation (EC) No 1335/2005 of 12 August 2005 (OJ 2005 L 211, p. 6).
3), kot je bila spremenjena z Uredbo Komisije (ES) �t. 1335/2005 z dne 12. avgusta 2005 (UL L 211, str. 6).
13 — Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ 1992 L 366, p. 10).
3600/92 z dne 11. decembra 1992 o podrobnih pravilih za izvajanje prve faze delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet (UL L 366, str. 10).
Directive 2002/37, adopted on the basis of Article 6(1) of Directive 91/414, amends that directive so as to include ethofumesate in Annex I thereto, subject to certain conditions.
Direktiva 2002/37, ki je bila sprejeta na podlagi člena 6(1) Direktive 91/414, zadnje navedeno direktivo dopolnjuje s tem, da pod določenimi pogoji v Prilogo I vključuje etofumesat.
(8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing ethofumesate, and in particular, to review existing authorisations in accordance with the provisions of Directive 91/414/EEC to ensure that the conditions regarding ethofumesate set out in Annex I to Directive 91/414/EEC are satisfied.
(8) Po vključitvi je treba državam članicam omogočiti določeno obdobje za izvajanje določb Direktive 91/414/EGS v zvezi s fitofarmacevtskimi sredstvi, ki vsebujejo etofumesat in zlasti za ponovni pregled obstoječih registracij v skladu z določbami Direktive 91/414/EGS, da zagotovijo, da so izpolnjeni pogoji v zvezi z etofumesatom iz Priloge I k Direktivi 91/414/EGS.
A longer period should be provided within which a complete dossier for each such plant protection product, satisfying the requirements of Annexes II and III to Directive 91/414/EEC, should be submitted and that product re-evaluated in accordance with the uniform principles laid down in Directive 91/414/EEC.’
Predpisati je treba tudi dalj�e obdobje, v katerem se predloži celotna dokumentacija za vsako tak�no fitofarmacevtsko sredstvo, ki izpolnjuje zahteve iz Prilog II in III k Direktivi 91/414/EGS, in v katerem se pripravek ponovno oceni v skladu z enotnimi načeli iz Direktive 91/414/EGS.“
The preamble to Directive 2002/37 includes the following recitals:
Preambula Direktive 2002/37 vsebuje te uvodne izjave:
Article 1 of Directive 2002/37 amends Annex I to Directive 91/414 so as to add ethofumesate thereto and include, under the heading ‘Specific provisions’:
Člen 1 Direktive 2002/37 spreminja Prilogo I k Direktivi 91/414 tako, da v to prilogo dodaja etofumesat in pod naslovom Posebne določbe vključuje:
‘Only uses as herbicide may be authorised.
„Registrira se lahko samo kot herbicid.
‘(5) It has appeared from the various examinations made that plant protection products containing ethofumesate may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report.
„(5) Različna izvedena preučevanja so pokazala, da lahko pričakujemo, da fitofarmacevtska sredstva z etofumesatom na splo�no izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile preučene in podrobno opisane v poročilu Komisije o pregledu.
It is therefore appropriate to include ethofumesate in Annex I to that Directive, in order to ensure that in all Member States authorisations of plant protection products containing ethofumesate can be granted in accordance with the provisions of Directive 91/414/EEC.
Zato je primerno vključiti etofumesat v Prilogo I te direktive, da se v vseh državah članicah zagotovi, da se fitofarmacevtska sredstva, ki vsebujejo etofumesat, lahko registrirajo v skladu z določbami Direktive 91/414/EGS.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethofumesate, and in particular Appendices I and II thereof, as final-
Za izvajanje enotnih načel iz Priloge VI se upo�tevajo sklepi poročila o pregledu za etofumesat in zlasti Dodatkov I in II k poročilu, kot so bili dokončno sprejeti v Stalnem
OPINION OF MS SHARPSTON — CASE C-361/06 satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Na osnovi te ocene določijo, ali pripravek izpolnjuje zahteve iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414/EGS.
Where necessary and by 28 February 2007 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.’ ised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account.
Kjer je potrebno in najkasneje do 28. februarja 2007 spremenijo ali prekličejo registracijo za vsako tak�no fitofarmacevtsko sredstvo.“ odboru za prehranjevalno verigo in zdravstveno varstvo živali 26. februarja 2002.
In this overall assessment Member States may pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and must apply risk mitigation measures, where appropriate.’
V tej celokupni oceni lahko države članice posebno pozornost namenijo varovanju podtalnice, če se aktivna snov uporablja v regijah, kjer so občutljiva tla in/ali podnebni pogoji, in obvezno predpi�ejo, kjer je to primerno, potrebne ukrepe za zmanj�anje tveganja.“
Directive 2002/37 entered into force on 1 March 2003. 16
Direktiva 2002/37 je začela veljati 1. marca 2003. 16
Article 4 of Directive 2002/37 provides:
Člen 4 Direktive 2002/37 določa:
Directive 91/414 has been amended by other directives, including Directive 2005/53.
Direktiva 91/414 je bila spremenjena z drugimi direktivami, med njimi z Direktivo 2005/53 17.
17The preamble to Directive 2005/53 includes the following recitals:
Preambula Direktive 2005/53 vključuje ti uvodni izjavi:
Without prejudice to the ob- ligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed
„(10) Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki so posledica vključitve aktivne snovi v Prilogo I, morajo imeti države članice po vključitvi
16 — Article 5.
16 – Člen 5.
17 — Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ 2005 L 241, p. 51).
17 – Direktiva Komisije 2005/53/ES z dne 16. septembra 2005 o spremembi Direktive Sveta 91/414/EGS zaradi vključitve klorotalonila, klorotolurona, cipermetrina, daminozida in tiofanat-metila kot aktivnih snovi (UL L 241, str. 51).
Member States shall, for each authorised plant protection product containing ethofumesate as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 1 March 2003, re-eval-uate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product
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/EGS, do 1. marca 2003 ponovno ocenijo to sredstvo v skladu z enotnimi načeli iz Priloge VI k Direktivi
FEINCHEMIE SCHWEBDA AND BAYER CROPSCIENCE ectives which have been adopted until now amending Annex I.’
FEINCHEMIE SCHWEBDA IN BAYER CROPSCIENCE ta razjasnitev v primerjavi z direktivami o spremembah Priloge I, sprejetimi do zdaj, državam članicam ali imetnikom registracij ne nalaga nobenih dodatnih obveznosti.“
Article 3 of Directive 2005/53 provides: a period of six months after inclusion to review existing authorisations of plant protection products containing [certain chemicals, not including ethofumesate] to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied.
Člen 3 Direktive 2005/53 določa: na voljo �est mesecev, da pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo [določene kemične snovi razen etofumesata], da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, in zlasti njenega člena 13 in zadevnih pogojev, določenih v Prilogi I.
Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
V skladu z določbami Direktive 91/414/EGS morajo države članice obstoječe registracije po potrebi spremeniti, nadomestiti ali preklicati.
By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
Z odstopanjem od zgornjega roka je treba zagotoviti dalj�e obdobje za predložitev in oceno celotne dokumentacije iz Priloge III za vsako fitofarmacevtsko sredstvo za vse predvidene uporabe v skladu z enotnimi načeli, določenimi v Direktivi 91/414/EGS.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing [certain chemicals] as active substances by 31 August 2006.
Države članice v skladu z Direktivo 91/414/EGS do 31. avgusta 2006 po potrebi spremenijo ali prekličejo obstoječe registracije za fitofarmacevtska sredstva, ki vsebujejo [določene kemične snovi] kot aktivne snovi.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to [certain chemicals] are met, with the exception of those identified in part B of the entries concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
Do tega datuma zlasti potrdijo, da so izpolnjeni pogoji iz Priloge I k navedeni direktivi, ki se nana�ajo na [določene kemične snovi], z izjemo tistih iz dela B vpisov, ki se nana�ajo na navedene aktivne snovi, in da ima imetnik dovoljenja [registracije] v skladu s pogoji člena 13 navedene direktive dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi.
The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
(11) 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 [registracij] nastopijo težave v zvezi z dostopom do podatkov.
(c) that is necessary for the implementation of a Community measure.’ containing [certain chemicals] as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 28 February 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entries in Annex I to that Directive concerning [certain chemicals].
(c) je to potrebno za izvr�itev ukrepa Skupnosti.“ sredstvo, ki vsebuje [določene kemične snovi], bodisi kot edino aktivno snov bodisi kot eno od več aktivnih snovi, ki se navedejo v Prilogi I k Direktivi 91/414/EGS najpozneje do 28. februarja 2006, ponovno ocenijo sredstvo v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414/EGS na podlagi dokumen -tacije, ki izpolnjuje zahteve iz Priloge III k navedeni direktivi, in ob upo�tevanju dela B vpisov v Prilogi I k navedeni direktivi o [določenih kemičnih snoveh].
On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC …’
Na podlagi te ocene ugotovijo, ali sredstvo izpolnjuje pogoje iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414/EGS […]“
Background to the main proceedings and question referred
Dejansko stanje v postopku v glavni stvari in vprašanje za predhodno odločanje
However, at the material time, Directive 2005/53 had not entered into force.
Vendar v času dejanskega stanja spora Direktiva 2005/53 �e ni začela veljati.
Relevant national law
Upoštevno nacionalno pravo
Feinchemie Schwebda GmbH and Bayer CropScience AG (‘the applicants’), producers of plant protection products, notified the Commission in accordance with the procedure laid down by Regulation No 3600/92 with a view to the inclusion of ethofumesate in Annex I to Directive 91/414.
Feinchemie Schwebda GmbH in Bayer CropScience AG (v nadaljevanju: tožeči stranki), proizvajalca fitofarmacevtskih sredstev, sta v skladu s postopkom, določenim z Uredbo �t. 3600/92, podala prijavo pri Komisiji, da bi v Prilogo I k Direktivi 91/414 vključila etofumesat.
In support of their application they submitted an Annex II dossier.
V utemeljitev sta predložila dokumentacijo iz Priloge II.
As a result, ethofumesate was added, with effect from 1 March 2003, to the list of active substances authorised for incorpo ration in plant protection products in Annex I to Directive 91/414.
Posledično je bil etofumesat z učinkom od 1. marca 2003 dodan na seznam aktivnih snovi iz Priloge I k Direktivi 91/414, ki se jih sme vključiti med fitofarmacevtska sredstva.
The referring court has drawn the attention of the Court of Justice to Article 7(1)(c) of the 1962 Law on Pesticides, which reads as follows:
Predložitveno sodi�če je Sodi�če opozorilo na člen 7(1)(c) Zakona o pesticidih iz leta 1962, ki določa:
The Board shall withdraw an authorisation or registration … if:
Agrichem BV (v nadaljevanju: Agrichem) je bil imetnik obstoječih registracij za
Agrichem BV (‘Agrichem’) held existing authorisations for seven products which contained ethofumesate as an active
Komisija prekliče registracijo ali dovoljenje […], če:
Summary of the observations of the parties substance.
Povzetek pisnih stališč strank sedem sredstev, ki so vsebovala etofumesat kot aktivno snov.
It did not act with the applicants as a co-notifier, nor did it submit an Annex II dossier.
S tožečima strankama ni nastopal kot soprijavitelj niti ni predložil dokumentacije iz Priloge II.
Written observations have been submitted by the applicants, Agrichem, the Belgian and Netherlands Governments and the Commission, all of whom, apart from the Belgian Government, were present at the hearing on 19 September 2007.
Pisna stali�ča so predložili tožeči stranki, Agrichem, belgijska in nizozemska vlada ter Komisija, ki so se vsi, razen belgijske vlade, udeležili obravnave 19. septembra 2007.
Agrichem’s authorisations were initially withdrawn by the College voor de toelating van bestrijdingsmiddelen (Netherlands Board for the authorisation of pesticides, ‘the CTB’), by decisions of 23 January 2004, on the basis that no Annex II dossier had been submitted.
College voor de toelating van bestrijdin -gsmiddelen (nizozemska komisija za registra -cijo pesticidov, v nadaljevanju: CTB) je sprva preklical Agrichemove registracije z odločbami z dne 23. januarja 2004, ker ni predložil dokumentacije iz Priloge II.
Those withdrawals were subsequently revoked by a decision of 19 November 2004 (‘the contested decision’) in which the CTB took the view that an Annex II dossier could not be requested under Article 4(1) of Directive 2002/37.
Ti preklici so bili pozneje razveljavljeni z odločbo z dne 19. novembra 2004 (v nadaljevanju: izpodbijana odločba), v kateri je CTB izrazil stali�če, da dokumentacije iz Priloge II ni mogoče zahtevati na podlagi člena 4(1) Direk -tive 2002/37.
With the exception of Agrichem, all those parties dispute the correctness of the contested decision.
Vse navedene stranke razen Agrichem so izpodbijale pravilnost izpodbijane odločbe.
They argue, broadly, that Article 13(1) and (3) of Directive 91/414 creates a situation in which the holder of an existing authorisation who is not a notifier must either hold, or have access to, an Annex II or Annex III dossier before September 2003.
Splo�neje so ugovarjale, da člen 13(1) in (3) Direktive 91/414 ustvarja položaj, v katerem mora imetnik obstoječe registracije, ki ni prijavitelj, pred septembrom 2003 imeti dokumentacijo ali imeti dostop do dokumentacije iz Priloge II ali iz Priloge III.
If such a party does not have access to such a dossier, Article 13 precludes a Member State from using the information in an existing Annex II or Annex III dossier in its possession to the benefit of that party by continuing an existing authorisation.
Če ta stranka nima dostopa do navedene dokumentacije, člen 13 preprečuje državam članicam, da informacije iz obstoječe dokumentacije iz Priloge II ali iz Priloge III, ki jo imajo na voljo, uporabljajo v dobro navedene stranke v obliki nadaljevanja obstoje - če registracije.
They contend that, as Directive 2002/37 should be interpreted in the light of Directive 91/414, the lack of express provision in Article 4(1) of Directive 2002/37 for the submission of a dossier during the re-examination process does not affect this preclusion.
Zatrjujejo, da dejstvo, da člen 4(1) Direktive 2002/37 ne vsebuje izrecne določbe za predložitev dokumentacije med postopkom ponovnega pregleda, ne vpliva na to oviro, saj je Direktivo 2002/37 treba razlagati ob upo�tevanju Direktive 91/414.
Agrichem’s argument focuses on the simple question of how best to interpret Directive 2002/37 and how that directive
Agrichemova trditev se osredotoča na preprosto vpra�anje, kako najbolje pojasniti Direktivo 2002/37 in kako se ta direktiva
fits with Directive 91/414.
ujema z Direktivo 91/414.
It is Agrichem’s submission that the relevant provisions of those directives do not require it to be in possession of a full Annex II or Annex III dossier at the end of the period specified in Article 4(1) of Directive 2002/37.
Agrichem zatrjuje, da upo�tevne določbe teh direktiv ne zahtevajo, da ima na koncu obdobja, določenega v členu 4(1) Direktive 2002/37, celotno dokumentacijo iz Priloge II ali iz Priloge III.
Agrichem also submits that those provisions do not oblige a Member State to withdraw an existing authorisation from a body which is not in possession of such a dossier at the end of that period.
Agrichem tudi meni, da te določbe državi članici ne nalagajo, naj prekliče obstoječo registracijo subjektu, ki ob koncu navedenega obdobja take dokumentacije nima.
Furthermore, it considers that the protection of information in Directive 91/414 operates to protect the investments of the developing companies.
Poleg tega po njenem mnenju varstvo podatkov v Direktivi 91/414 služi varovanju naložb podjetij, ki delujejo na področju razvoja.