natgillin/translations-raw huggingface dataset:
In my view the reading proposed by the applicants amounts to a lock-out resulting from a complete prohibition on the use of active substances added to the list in Annex I to Directive 91/414, which applies to all parties other than the actual notifying bodies.
Menim, da se razlaga, ki jo predlagata tožeči stranki, opira na blokado, ki je posledica popolne prepovedi uporabe aktivne snovi, ki je vpisana na seznam v Prilogi I k Direktivi 91/414, ki se uporablja za vse stranke, razen za dejanske prijavitelje.
Although that lock-out would only last for a short period by virtue of Article 13(3)(c) and Article 13(3)(d), it is an anti-competitive measure.
Čeprav bi bila ta blokada na podlagi člena 13(3)(c) in (d) kratkotrajna, gre za protikonkurenčni ukrep.
If the legislator intended to permit such a result, one would expect it to be stated explicitly in the legislation, rather than being left to be inferred indirectly.
Če bi zakonodajalec nameraval dovoliti tak rezultat, bi pričakovali, da bo izrecno naveden v zakonodaji, namesto da je prepu�čen posrednemu sklepanju.
According to the Commission, Article 13 aims to protect the notifying authorisation holders by granting future authorisations on the basis of an Annex II dossier.
Po mnenju Komisije je namen člena 13 za�čititi imetnike registracij, ki podajo zahtevek, tako, da se jim zagotovi bodoča registracija na podlagi dokumentacije iz Priloge II.
For that reason, Article 13(1) should be construed as covering holders of existing authorisations.
Zato bi morali člen 13(1) razlagati tako, da so vključeni imetniki obstoječih registracij.
Otherwise, there is a difference in treatment between holders of existing authorisations (no dossier needed) and new applications for authorisation (dossier needed) which is unjust.
V nasprotnem primeru bi pri�lo do nepravičnega različnega obravnavanja imetnikov obstoječih registracij (za katere dokumentacija ni obvezna) in tistimi, ki predložijo zahtevek za novo registracijo (za katere je dokumentacija obvezna).
Furthermore, Article 13(7) appears to differentiate
Menim, da ta razlaga ni prepričljiva, ker ni razloga, zakaj bi imetnik obstoječe
Such a lock-out would also have the effect of prohibiting bodies which have already been granted authorisation to use specific plant protection products containing
Taka blokada bi vsebovala tudi prepoved nadaljnje uporabe subjektom, ki so že pridobili registracijo za uporabo posebnih fitofarmacevtskih sredstev, ki vsebujejo take aktivne
It would in my view be both disproportionate and anti-competitive so to remove a previously-acquired right, validly granted under Article 8 of Directive 91/414.
Po mojem mnenju bi bilo nesorazmerno in protikonkurenčno odpraviti prej pridobljeno pravico, ki je bila veljavno podeljena na podlagi člena 8 Direktive 91/414.
I am not prepared to construe Article 13(1) in that way.
Ne nagibam se k tovrstni razlagi člena 13(1).
I therefore conclude that a holder of an existing authorisation does not come within the scope of Article 13(1).
Zato zaključujem, da za imetnika obstoječe registracije člen 13(1) ne velja.
In reply to that submission, Agrichem states that it has in fact already completed such a dossier, but was unable to do so before the deadline set out in Article 4(1) of Directive 2002/37.
Agrichem v odgovor na to trditev meni, da je dejansko že dopolnil tako dokumentacijo, vendar tega ni mogel storiti pred rokom, določenim v členu 4(1) Direktive 2002/37.
Agrichem argues that it has made no profit from the work of the applicants.
Agrichem navaja, da se ni okoristil z delom tožečih strank.
On the legal level, Agrichem argues that on a proper reading of Article 4(1) of Directive 2002/37, all a company must show in order to retain an existing authorisation is the information in Annex I, which is already in the public domain.
Na pravni ravni Agrichem zatrjuje, da morajo na podlagi pravilne razlage člena 4(1) Direktive 2002/37 vsa podjetja, da bi ohranila obstoječe registracije, predložiti podatke iz Priloge I, ki so že javno dostopni.
This would therefore operate smoothly in conjunction with Article 13 of Directive 91/414, which would only restrict the use of information in the Annex II and III dossiers.
To bi tako brez težav delovalo v povezavi s členom 13 Direktive 91/414, ki bi omejeval le uporabo podatkov dokumentacij iz Priloge II in Priloge III.
Such a reading sits more naturally with the wording of the directives themselves.
Taka razlaga bi bila ustreznej�a glede na besedilo direktiv.
An alternative argument which has been proposed is that Article 13(3) prevents a Member State from making use of the contents of an Annex II or III dossier for the benefit of parties which do not have access to such a dossier.
Uveljavljana je bila podredna trditev, da člen 13(3) državam članicam prepoveduje uporabo vsebine dokumentacije iz Priloge II ali iz Priloge III v korist strank, ki nimajo dostopa do te dokumentacije.
The applicants submit that Article 13(3) of Directive 91/414 aims to protect the investments of notifying parties by way of a ‘closed dossier’ system.
Tožeči stranki zatrjujeta, da je namen člena 13(3) Direktive 91/414 za�čiti naložbe prijaviteljev s sistemom „zaprte dokumentacije“.
They argue that for a period of five years following notification, information contained in such dossiers must not be used by, or to the benefit of, any applicants for authorisation which do not
Menita, da v petih letih od vložitve zahtevka prijavitelji za registracije, ki sami nimajo dokumentacije iz Priloge II ali do nje
I do not read Article 4(1) of Directive 2002/37 as requiring the holder of an existing authorisation to have access to an Annex II or Annex III dossier.
Člena 4(1) Direktive 2002/37 ne razumem tako, da bi imetnik obstoječe registracije imel dostop do dokumentacije iz Priloge II ali iz Priloge III.
It follows that Article 13(3) of Directive 91/414 cannot be relied upon by the applicants, as it does not apply in such a situation. Agrichem holds
Iz tega sledi, da se tožeči stranki ne moreta sklicevati na člen 13(3) Direktive 91/414, ker se v tem primeru ne uporablja. Agrichem je imetnik obstoječe
FEINCHEMIE SCHWEBDA AND BAYER CROPSCIENCE data protection legislation 20would apply, in the absence of any other, more specific, provisions.
FEINCHEMIE SCHWEBDA IN BAYER CROPSCIENCE okoli�činah, in ker ni drugih, specialnej�ih določb, uporabljala običajna zakonodaja o za�čiti podatkov 20.
Those general provisions on data protection allow the need to preserve the confidentiality of business secrets to be taken into account.
Te splo�ne določbe o za�čiti podatkov dopu�čajo, da se upo�teva zahteva po za�čiti zaupnosti poslovnih skrivnosti.
existing authorisations for certain plant protection products containing ethofumesate as an active substance which it was granted in accordance with Article 8(2) of Directive 91/414.
registracije za določena fitofarmacevtska sredstva z etofumesatom kot aktivno snovjo, ki mu je bila podeljena na podlagi člena 8(2) Direktive 91/414.
It is not a new applicant and therefore does not fall within the scope of Article 13(1) of Directive 91/414.
Ne gre za novega prijavitelja, in zato zanj ne velja člen 13(1) Direktive 91/414.
Neither it, nor the Member State, needs to have access to, or make use of the information in, an Annex II or III dossier until there is a re-evaluation of its existing authorisations under Article 4(2) of Directive 2002/37.
Agrichem in država članica ne potrebujeta dostopa do dokumentacij iz Priloge II ali iz Priloge III oziroma ne moreta uporabljati podatkov iz teh dokumentacij, dokler njegove obstoječe registracije niso ponovno ocenjene v skladu s členom 4(2) Direk -tive 2002/37.
The data protection issue
Vprašanje zaščite podatkov
Finally, I should mention that in reaching the contested decision, the CTB expressed the concern that if Article 4(1) of Directive 2002/37 is read literally (as in my view should be the case) that effectively renders the provisions of Directive 91/414 meaningless in particular as regards data protection.
Nazadnje bi morala omeniti, da je CTB pri sprejemanju izpodbijane odločbe izrazil pomislek, da bi določbe Direktive 91/414 pri dobesedni razlagi člena 4(1) Direktive 2002/37 (kot bi jo po mojem mnenju morali razlagati) postale brez pomena zlasti glede za�čite podatkov.
A subsidiary issue arises in relation to data protection, inasmuch as the data held by Agrichem were not sufficient to constitute a complete Annex II dossier.
Dodatno vpra�anje se poraja glede za�čite podatkov, kolikor podatki, ki jih je imel Agrichem, niso zado�čali za izdelavo celotne dokumentacije iz Priloge II.
The question then arises whether Agrichem is entitled to refer to the data which were taken into account in the Community evaluation for ethofumesate which led to Directive 2002/37.
Vpra�anje torej je, ali se je bil Agrichem upravičen sklicevati na podatke, ki so bili upo�tevani pri skupnostni oceni etofumesata, ki je privedla do izdaje Direktive 2002/37.
I do not share that concern.
S tem stali�čem se ne strinjam.
Permitting Agrichem to continue to use those plant protection products containing ethofumesate as an active substance in respect of which it has existing authorisations does not entail granting it permission to access the data required to create an Annex II dossier. All that is required is the information in Annex
Dovoljenje Agrichemu, da �e naprej uporablja tista fitofarmacevtska sredstva, ki vsebujejo etofumesat kot aktivno snov, za katere ima obstoječe registracije, ne pomeni, da se mu dovoli dostop do podatkov, potrebnih za izdelavo dokumentacije iz Priloge II.
I, which is in the public domain.
Podatki, ki se zahtevajo, so podatki, ki so v Prilogi I in so javno dostopni.
20 — Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ 1995 L 281, p.
20 – Direktiva 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih (UL L 281, str. 31) ali v primeru informacij, ki so bile predložene institucijam Skupnosti in jih te hranijo, Uredba (ES) �t.
31) or Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p.
1049/2001 Evropskega parlamenta in Sveta z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije (UL L 145, str. 43).
That issue is relevant only if, contrary to the view that I have expressed, Directives 91/414 and 2002/37 properly interpreted require Agrichem to submit a complete Annex II dossier, so that in order to do so it needs to seek access to the information submitted by the applicants.
To vpra�anje je relevantno le, če v nasprotju z mojim stali�čem pravilno razlagani direktivi 91/414 in 2002/37 nalagata, da Agrichem predloži celotno dokumentacijo iz Priloge II, tako da se mora v ta namen potruditi do dostopa do podatkov, ki sta jih predlo -žili tožeči stranki. Zdi se mi, da bi se v teh
‘Article 4(1) of Commission Directive 2002/37/EC does not require Member States to terminate before 1 September 2003 an authorisation granted pursuant to the first subparagraph of Article 8(2) of Council Directive 91/414/EEC for a plant protection product containing ethofumesate as an active substance on the ground that the holder of that authorisation does not have, or have access to, a dossier satisfying the requirements of Annex II to Directive 91/414.’
Člen 4(1) Direktive Komisije 2002/37/ES ne zavezuje držav članic, da registracijo, podeljeno na podlagi člena 8(2) Direktive Sveta 91/414/EGS za fitofarmacevtsko sredstvo, ki vsebuje etofumesat kot aktivno snov, prekličejo pred 1. septembrom 2003, ker imetnik te registracije nima ali nima dostopa do dokumentacije, ki izpolnjuje pogoje iz Priloge II k Direktivi 91/414.
JUDGMENT OF THE COURT (Third Chamber)
SODBA SODIŠČA (tretji senat) z dne 22. maja 2008 *
JUDGMENT OF 22. 5.
SODBA Z DNE 22. 5.
2008 — CASE C-361/06
2008 – ZADEVA C-361/06
— the Commission of the European Communities, by B. Doherty and M. van Heezik, acting as Agents, after hearing the Opinion of the Advocate General at the sitting on 29 November 2007, gives the following
– za Komisijo Evropskih skupnosti B. Doherty in M. van Heezik, zastopnika, po predstavitvi sklepnih predlogov generalne pravobranilke na obravnavi 29. novembra 2007 izreka naslednjo
This reference for a preliminary ruling concerns the interpretation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p.
Predlog za sprejetje predhodne odločbe se nana�a na razlago Direktive Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet (UL L 230, str. 1, in popravek, UL 1992, L 170, str.
40), Commission Directive 2002/37/EC of 3 May 2002 amending Directive 91/414 to include ethofumesate as an active substance (OJ 2002 L 117, p.
40) in Direktive Komisije 2002/37/ES z dne 3. maja 2002 o spremembi Direktive Sveta 91/414/EGS zaradi vključitve etofumesata kot aktivne snovi (UL L 117, str.
10) and 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 Directive 91/414 (OJ 1992 L 366, p. 10).
10) ter Uredbe Komisije (EGS) �t. 3600/92 z dne 11. decembra 1992 o podrobnih pravilih za izvajanje prve faze delovnega programa iz člena 8(2) Direktive 91/414/EGS (UL L 366, str. 10).
The reference has been made in the context of an action brought by Feinchemie Schwebda GmbH (‘Feinchemie’) and Bayer CropScience AG (‘Bayer’) against the College voor de toelating van bestrijdingsmiddelen (Netherlands Board for the authorisation of pesticides, ‘the CTB’) in respect of the CTB’s decision of 19 November 2004, by which it upheld the complaint brought by Agrichem BV (‘Agrichem’) against the seven decisions the CTB had taken on 23 January 2004.
Ta predlog je bil vložen v okviru spora med družbama Feinchemie Schwebda GmbH ter Bayer CropScience AG (v nadaljevanju: Feinchemie oziroma Bayer) in College voor de toelating van bestrijdingsmiddelen (v nadaljevanju: College) zaradi odločbe z dne 19. novembra 2004, s katero je slednje ugodilo ugovoru družbe Agrichem BV (v nadaljevanju: Agrichem) v zvezi s sedmimi odločbami, ki jih je sprejelo 23. januarja 2004.
By those decisions, the CTB had withdrawn the authorisations held by Agrichem for the placing on the market of plant protection products containing ethofumesate as an active substance.
College je s temi odločbami preklicalo registracije, ki jih je imel Agrichem za dajanje fitofarmacevtskih sredstev, ki vsebujejo „etofumesat“ kot aktivno snov, v promet.
Under Article 2(1) of Directive 91/414, ‘plant protection products’ are ‘active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user’ which are intended, inter alia, to protect plants or plant products against all harmful organisms.
„Fitofarmacevtska sredstva“ v smislu člena 2, točka 1, Direktive 91/414 pomenijo „aktivne snovi in pripravk[e], ki vsebujejo eno ali več aktivnih snovi v obliki, v kateri se dobavljajo uporabniku“ in ki so med drugim namenjena za varstvo rastlin ali rastlinskih proizvodov pred �kodljivimi organizmi.
In Article 2(4) of that directive, active substances are defined as ‘substances or micro-organisms including viruses, having general or specific action … against harmful organisms; or … on plants, parts of plants or plant products’.
Člen 2, točka 4, te direktive aktivne snovi opredeljuje kot „snovi ali mikroorganizme, vključno z virusi, ki imajo splo�en ali poseben učinek [bodisi] na �kodljive organizme [bodisi] na rastline, dele rastlin ali rastlinske proizvode“.
Article 3(1) of Directive 91/414 provides that a plant protection product may not, as a rule, be placed on the market and used in the territory of a Member State unless the competent authorities of that Member State have authorised the product in accordance with the provisions of that directive.
V skladu s členom 3(1) navedene direktive se fitofarmacevtsko sredstvo načeloma lahko da v promet in uporablja na ozemlju države članice le, če ga registrirajo pristojni organi te države članice v skladu z določbami te direktive.
Article 4(1)(a) of Directive 91/414 provides that ‘Member States shall ensure that a plant protection product is not authorised unless … its active substances are listed in Annex I and any conditions laid down therein are fulfilled’, as well as the conditions set out in Article 4(1)(b) to (f).
Člen 4(1)(a) Direktive 91/414 določa, da „države članice zagotovijo, da se fitofarmacevtsko sredstvo ne registrira, razen če […] so aktivne snovi v fitofarmacevtskem sredstvu uvr�čene v Prilogo I in so izpolnjeni vsi pogoji iz te priloge“ ter pogoji iz navedenega odstavka 1, od (b) do (f), tega člena.
The conditions for including an active substance in Annex I to Directive 91/414 are set out in Article 5 of that directive.
Pogoji za uvrstitev aktivnih snovi v Prilogo I k Direktivi 91/414 so določeni v členu 5 te direktive.
By way of a particular requirement, it must be expected, in the light of current scientific and technical knowledge, that the residues of plant protection products containing the active substance in question, consequent on application consistent with good plant protection practice, will not have any harmful effects on human or animal health or on groundwater and that they will not have any unacceptable influence on the environment.
Ob upo�tevanju znanstvenega in tehničnega znanja je nujno zlasti, da se lahko pričakuje, da ostanki fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, pri nana�anju v skladu z dobro prakso varstva rastlin ne bodo imeli nikakr�nega �kodljivega vpliva na zdravje ljudi ali živali ali na podtalnico oziroma nesprejemljivega vpliva na okolje.
The procedure for inclusion of an active substance in Annex I to Directive 91/414 is governed by Article 6 of that directive.
Postopek uvrstitve aktivne snovi v Prilogo I k Direktivi 91/414 je urejen v členu 6 te direktive.
Pursuant to Article 6(1) of Directive 91/414, the Commission of the European Communities, assisted by the Standing Committee on the Food Chain and Animal Health, has the power to include an active substance in Annex I. According to Article 6(2) of Directive 91/414, the application for the inclusion of an active substance in Annex I thereto must be accompanied by a dossier satisfying the conditions set out in Annex II thereto (‘Annex II dossier’) and a dossier complying with Annex III thereto (‘Annex III dossier’) on at least one preparation containing that active substance.
Komisija Evropskih skupnosti, ki ji pomaga Stalni odbor za prehranjevalno verigo in zdravje živali, je na podlagi odstavka 1 tega člena pristojna za uvrstitev aktivne snovi v to prilogo. V skladu z odstavkom 2 navedenega člena je treba zahtevku za uvrstitev aktivne snovi v navedeno prilogo priložiti dokumentacijo, ki izpolnjuje zahteve iz Priloge II k tej direktivi (v nadaljevanju: dokumentacija iz Priloge II), in dokumentacijo v skladu s Prilogo III k navedeni direktivi (v nadaljevanju: dokumentacija iz Priloge III) o najmanj enem pripravku, ki vsebuje to aktivno snov.
Article 8 of Directive 91/414 concerns transitional measures and derogations.
Člen 8 te direktive se nana�a na prehodne ukrepe in odstopanja.
According to Article 8(2):
V odstavku 2 določa:
‘By way of derogation from Article 4 and without prejudice to paragraph 3 or to Directive 79/117/EEC, a Member State may, during a period of 12 years following the notification of this Directive, authorise the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this Directive.
„Z odstopanjem od člena 4 in brez poseganja v odstavek 3 ali Direktivo 79/117/EGS lahko država članica v dvanajstih letih od notifikacije te direktive registrira za dajanje v promet na svojem ozemlju fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, ki niso uvr�čene v Prilogo I, in so že v prometu dve leti po dnevu notifikacije te direktive.
After the adoption of this Directive, the Commission shall commence a programme of work for the gradual examination of these active substances within the 12-year
Po sprejetju te direktive Komisija začne z izvajanjem delovnega programa za postopen pregled teh aktivnih snovi v obdobju dvanajstih let iz prej�njega odstavka.
2008 — CASE C-361/06 period referred to in the foregoing subparagraph.
2008 – ZADEVA C-361/06
This programme may require interested parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme.
Ta program lahko zahteva od zainteresiranih strani, da predložijo Komisiji in državam članicam vse potrebne podatke v roku, ki ga določa program.
A Regulation, adopted according to the procedure laid down in Article 19, will set out all the provisions necessary for the implementation of the programme.
Potrebne določbe za izvajanje tega programa bodo določene v uredbi, ki se sprejme v skladu s postopkom iz člena 19.
During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period.’
V obdobju dvanajstih let iz prvega pododstavka se lahko na podlagi pregleda aktivne snovi, ki ga opravi Odbor iz člena 19, po postopku iz navedenega člena odloči, da se snov uvrsti v Prilogo I in določi pogoje za uvrstitev, ali da se take aktivne snovi ne uvrsti v Prilogo I, če zahteve iz člena 5 niso izpolnjene ali pa potrebni podatki niso bili predloženi v predpisanem roku. Države članice zagotovijo, da se v predpisanem roku ustrezne registracije odobri, prekliče oziroma spremeni.“
Article 13 of Directive 91/414 provides:
Člen 13 Direktive 91/414 določa:
‘1. … Member States shall require that applicants for authorisation of a plant protection product submit with their application:
„1. […] države članice zahtevajo, da vlagatelji za registracijo fitofarmacevtskega sredstva skupaj s zahtevkom predložijo:
(a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and
(a) dokumentacijo, ki glede na trenutno znanstveno in tehnično znanje izpolnjuje zahteve iz Priloge III; in
(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II.
(b) za vsako aktivno snov v fitofarmacevtskem sredstvu dokumentacijo, ki glede na trenutno znanstveno in tehnično znanje izpolnjuje zahteve iz Priloge II.
In granting authorisations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:
Pri registraciji države članice ne bodo uporabljale podatkov iz Priloge II v korist drugih vlagateljev: