natgillin/translations-raw huggingface dataset:
(a) pogoje uporabe, potrebne za skladnost s pogoji in zahtevami iz uredbe , ki dovoljuje aktivne snovi, varovala in sinergiste , in z zahtevami in pogoji za fitofarmacevtska sredstva iz člena 4(3);
(a) the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists and the requirements and conditions for plant protection products set out in Article 4(3);
(b) razvrstitev fitofarmacevtskih sredstev v skladu z Direktivo 1999/45/ES ;
(b) a classification of the plant protection product pursuant to Directive 1999/45/EC ;
(c) navodila za pravilno uporabo v skladu z načeli integriranega varstva rastlin pred škodljivci, kot je opredeljeno v členu 3, od leta 2012 dalje;
(c) indications for proper use according to the principles of Integrated Pest Management as defined in Article 3, to apply from 2012 onwards;
(d) obveznost obveščanja vseh prebivalcev in sosedov, ki bi lahko bili izpostavljeni zanašanju škropiva in drugim virom izpostavljenosti.
(d) the obligation to inform any residents and neighbours who could be exposed to the spray drift and other sources of exposure.
Morali bi pojasniti pogoje za posebne zahteve in omejitve.
Conditions for specific requirements and restrictions should be clarified.
Predlog spremembe temelji na prepričanju, da je registracija v skladu z drugimi določbami te uredbe.
This amendment deems the authorisation in line with other provisions in this Regulation.
Navesti bi morali vsaj pogoje in načela integriranega varstva rastlin pred škodljivci ter obveščanje prebivalcev in sosedov.
The conditions and principles of Integrated Pest Management and informing residents and neighbours should be formulated as a minimum.
Člen 30, odstavek 2, pododstavek 1 a (novo)
Article 30, paragraph 2, subparagraph 1 a (new)
Te zahteve v vsakem primeru določajo:
These requirements shall in any case cover:
– največji odmerek na hektar za vsako uporabo;
- the maximum dose per hectare in each application;
– obdobje med zadnjo uporabo in spravilom pridelka,
- the period between the last application and harvest;
– število uporab na leto.
- the number of applications per year.
Člen 30, odstavek 3, uvodni del
Article 30, paragraph 3, introductory part
Zahteve iz odstavka 2 lahko vključujejo :
The requirements referred to in paragraph 2 may include:
Zahteve iz odstavka 2 morajo vključevati :
The requirements referred to in paragraph 2 should include:
Člen 30, odstavek 3, točka (a)
Article 30, paragraph 3, point (a)
(a) omejitev sredstev v zvezi z distribucijo in uporabo fitofarmacevtskih sredstev za zaščito zdravja zadevnih distributerjev, uporabnikov in delavcev;
(a) a restriction of the product with respect to the distribution and use of the plant protection product to protect the health of the distributors, users and workers concerned;
(a) omejitev sredstev v zvezi z distribucijo in uporabo fitofarmacevtskih sredstev za zaščito zdravja zadevnih distributerjev, uporabnikov , delavcev , prebivalcev, navzočih oseb in potrošnikov, zaščito zdravja živali ali okolja ;
(a) a restriction of the product with respect to the distribution and use of the plant protection product to protect the health of the distributors, users , workers , residents, bystanders and consumers concerned , animal health or the environment ;
To vključuje poklicne in nepoklicne uporabnike, prebivalce, navzoče osebe, delavce, posebne ranljive skupine in potrošnike, ki so pesticidom neposredno in posredno izpostavljeni preko zraka, hrane, krme, vode in okolja.
This includes professional and non-professional users, residents, bystanders, workers, specific vulnerable groups and consumers, directly or indirectly exposed through air, food, feed, water and the environment.
Člen 30, odstavek 3, točka (b a) (novo)
Article 30, paragraph 3, point (b a) (new)
(ba) kakršne koli omejitve ali prepovedi uporabe pesticidov na območjih, ki jih uporablja širša javnost ali občutljive skupine prebivalstva, kot so stanovanjska naselja, parki, javni vrtovi, športna, šolska, otroška igrišča itd., in v okolici teh območij;
(ba) any restrictions or prohibitions of pesticide use in and around areas used by the general public or by sensitive population groups, s uch as residential areas, parks, public gardens, sports grounds, school grounds, children’s playgrounds etc.
Z zakonom določeni pogoji uporabe pri odobritvi vseh pesticidov bi morali vsebovati podrobne zahteve za kakršno koli prepoved uporabe pesticidov na območjih, ki jih uporablja širša javnost ali občutljivo prebivalstvo, kot so stanovanjska naselja, parki, javni vrtovi, športna, šolska, otroška igrišča itd., in v okolici teh območij.
The statutory conditions of use in the approval for all pesticides should contain detailed requirements for any prohibition of pesticide use in and around areas used by the general public or by sensitive population, such as residential areas, parks, public gardens, sports grounds, school grounds, children’s playgrounds etc.
Člen 32, odstavka 1 in 2
Article 32, paragraphs 1 and 2
Oseba, ki želi dati fitofarmacevtsko sredstvo v promet, za registracijo zaprosi osebno ali preko zastopnika v vsaki posamezni državi članici, v kateri se bo fitofarmacevtsko sredstvo dalo v promet.
A person who wishes to place a plant protection product on the market shall apply for an authorisation, in person or via a representative, to each Member State where the plant protection product is intended to be placed on the market.
Oseba, ki želi dati fitofarmacevtsko sredstvo v promet, o tem obvesti Komisijo.
The person who wishes to place a plant protection product on the market shall notify the Commission.
To obvestilo vsebuje informacije iz odstavka 2 in povzetek dokumentacije iz odstavka 3(a).
This notification shall include the information referred to in paragraph 2 and the summary dossier referred in paragraph 3(a) .
Vloga mora vsebovati naslednje:
The application shall include the following:
(a) seznam območij in držav članic, kjer je vlagatelj zaprosil za odobritev;
(a) a list of the zones and the Member States where the applicant has made an application;
(a) seznam držav članic, kjer je vlagatelj zaprosil za odobritev;
(a) a list of the Member States where the applicant has made an application;
(b) predlog, katera država članica naj oceni zahtevek za zadevno območje;
(b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned;
(c) overjeno kopijo kakršnih koli registracij, ki so že bile izdane za to fitofarmacevtsko sredstvo v državi članici.
(c) a certified copy of any authorisations already granted for that plant protection product in a Member State.
V predlaganem besedilu so o registraciji obveščene samo države članice, kjer se predloži zahtevek za registracijo.
In the proposed text, only the Member States where an application for authorisation is submitted are informed about the application.
To ne velja za veljavno Direktivo 91/414, ki določa, da mora vlagatelj obvestiti vse države članice in jim poslati popolno dokumentacijo.
This is different in the current Directive 91/414, where the applicant has to inform every Member state by sending a complete dossier.
Člen 32, odstavek 3, točka (b)
Article 32, paragraph 3, point (b)
(b) za vsako aktivno snov, varovalo in sinergist v fitofarmacevtskem sredstvu popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi, varovalu in sinergistu in
(b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; and
(b) za vsako aktivno snov, varovalo in sinergist, pomožno snov v formulaciji in dodatek v fitofarmacevtskem sredstvu popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi, varovalu in sinergistu, pomožni snovi v formulaciji in dodatku, prav tako popolna dokumentacija in njen povzetek o skupnih učinkih aktivne (aktivnih) snovi, varovala (varoval), sinergista (sinergistov), pomožne (pomožnih) snovi v formulaciji in dodatka (dodatkov) v fitofarmacevtskem sredstvu.
(b) for each active substance, safener and synergist, co-formulant and adjuvant contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist, co-formulant and adjuvant , as well as a complete and summary dossier on the combined effect of the active substance(s), safener(s) and synergist(s), co-formulant(s) and adjuvant(s) contained in the plant protection product .
Jasno je, da se varovala, sinergisti, pomožne snovi v formulaciji in dodatki dodajajo zato, da se izboljša ali spremeni učinek aktivne snovi, kar pomeni, da se zaradi tega njihov skupni učinek razlikuje od učinka posamezne snovi.
Clearly safeners, synergists, co-formulants and adjuvants are added to enhance or modify the effect of the active substance, making the combined effect different from the added-on effect of the individual substances.
Zato bi morali oceniti tudi njihov skupni učinek.
Therefore, the combined effect should also be evaluated.
Člen 32, odstavek 3, točka (c)
Article 32, paragraph 3, point (c)
(c) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev podvajanja preskusov ;
(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid duplicative testing;
(c) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev poskusov na živalih in podvajanja poskusov na vretenčarjih ;
(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals ;
Člen 32, odstavek 5, pododstavek 2
Article 32, paragraph 5, subparagraph 2
Na zahtevo države članice vlagatelj zagotovi vzorce fitofarmacevtskega sredstva in analitične standarde njegovih sestavin.
On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients.
Vlagatelj državam članicam, udeleženim pri oceni, na zahtevo zagotovi vzorce fitofarmacevtskega sredstva in analitične standarde njegovih sestavin.
On request, the applicant shall provide the Member State s involved in the assessment with samples of the plant protection product and analytical standards of its ingredients.
Člen 32, odstavek 5 a (novo)
Article 32, paragraph 5 a (new)
Na zahtevo vlagatelj zagotovi vsem ostalim državam članicam popolno dokumentacijo iz odstavka 3(a).
On request, the applicant shall provide any other Member States with the complete dossier referred to in paragraph 3(a).
V vseh državah članicah se uporabljajo enotni obrazci za zahtevek.
Application forms shall be standard in all Member States.
Zahtevek preuči država članica, ki jo je predlagal vlagatelj , razen če ga želi preučiti druga država članica z istega območja .
The application shall be examined by the Member State proposed by the applicant , unless another Member State in the same zone agrees to examine it.
Država članica, ki bo preučila zahtevek, o tem obvesti vlagatelja.
The Member State which will examine the application shall inform the applicant.
Zahtevek preuči država članica, kjer vlagatelj predloži zahtevek , razen če ga prostovoljno želi preučiti druga država članica.
The application shall be examined by the Member State where the applicant submits the application , unless another Member State volunteers to examine it.
Na zahtevo države članice, ki preučuje zahtevek, druge države članice na istem območju, katerim je bil zahtevek predložen, sodelujejo, da se zagotovi pravična razdelitev delovne obremenitve.
At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload.
Na zahtevo države članice, ki preučuje zahtevek, druge države članice sodelujejo, da se zagotovi pravična razdelitev delovne obremenitve.
At the request of the Member State examining the application, the other Member States shall cooperate to ensure a fair division of the workload.
Druge države članice znotraj območja, katerim je bil predložen zahtevek, prenehajo preučevati zahtevek, dokler država članica , ki preučuje zahtevek , ne predloži ocene .
The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application.
Druge države članice imajo pravico, da pošljejo svoje pripombe državi članici , ki preučuje zahtevek.
The other Member States shall have the right to send their comments to the Member State examining the application.
Rešitev, ki ne zahteva veliko časa ali dela, je obvestiti ali seznaniti vse ostale države članice z zahtevkom in jim omogočiti, da zahtevajo predložitev popolne dokumentacije.
A solution not requiring much time or administration work is to inform or notify all the other Member States about the application and by giving those Member States the possibility to request a complete dossier.
Poleg tega države članice morajo imeti pravico, da posredujejo svoje pripombe državi članici, ki preučuje zahtevek.
Furthermore the Member States shall have the right to give their comments to the Member State evaluating the dossier.
To prispeva h kakovosti in enotnosti ocen v vseh državah.
This contributes to the quality of the evaluation and to the uniformity of the evaluation in all countries.
Člen 34 a
Article 34 a
Baza podatkov Agencije
Database of the Authority
Ko je obveščen o tem, katera država članica bo preučila zahtevek, vlagatelj nemudoma posreduje Agenciji popolno dokumentacijo in njen povzetek iz člena 32(3)(a) in (b) ter informacije iz člena 32(3)(c).
Upon being informed which Member State will examine the application, the applicant shall immediately forward to the Authority the complete and the summary dossiers referred to in Article 32(3)(a) and (b) and the information referred to in Article 32(3)(c).
Agencija brez odlašanja zagotovi, da je povzetek dokumentacije dostopen za javnost, razen kakršnih koli zaupnih podatkov iz člena 60 ter podatkov iz člena 32(3)(c).
The Authority shall without delay make available to the public the summary dossiers, excluding any information which is confidential under Article 60, and the information referred to in Article 32(3)(c).
V skladu z zadnjim pododstavkom členov 9(3) in 10.
Conform the last subparagraph of Article 9(3) and Article 10.
V povezavi s predlogi sprememb k uvodni izjavi 32 ter k členom 54(1), 57(1) in (2) ter 58(-1).
Linked to Amendments of Recital 32 and Articles 54(1), 57(1) and (2) and 58(-1).
Zaradi lažje izmenjave podatkov je treba vzpostaviti osrednjo bazo podatkov, ki bi jo vodila Agencija in bi obsegala vse informacije o poskusih in študijah, ki so bili predhodno izvedeni za namene te uredbe.
In order to facilitate data sharing it is necessary to establish one central database with all the information on tests and studies carried out previously for the purposes of this Regulation, managed by the Authority.
Zaradi zagotavljanja preglednosti glede prizadevanja vlagateljev za preprečevanje poskusov na živalih bi morale biti tudi informacije iz člena 32(3)(c) javno dostopne.
The information referred to in Article 32(3)(c) should also be publicly available to ensure transparency in relation to the steps taken by applicants to avoid animal testing.
Člen 35, odstavek 1, pododstavka 1 in 2
Article 35, paragraph 1, subparagraphs 1 and 2
Država članica, ki preučuje zahtevek, opravi neodvisno, objektivno in pregledno oceno glede na sedanje znanstvene in tehnične dosežke.
The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge .
Država članica, ki preučuje zahtevek, opravi neodvisno, objektivno in pregledno oceno glede na sprejete znanstvene in tehnične smernice in zahteve, ki obstajajo v času vložitve zahtevka, brez poseganja v člen 21.
The Member State examining the application shall make an independent, objective and transparent assessment in the light of the accepted scientific and technical guidelines and requirements existing at the time of application without prejudice to Article 21.
Uporabi enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6) za določitev, ali fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29, če se uporablja v skladu s členom 52 in v skladu z vsemi realnimi običajnimi pogoji za uporabo in posledicami uporabe pod odobrenimi pogoji.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish whether the plant protection product meets the requirements provided for in Article 29, where used in accordance with Article 52, and under all realistic normal conditions of use, and the consequences of its use under the authorised conditions.
Uporabi enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6) za določitev, ali fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29, če se uporablja v skladu s členom 52 in v skladu z vsemi realnimi pogoji za uporabo in posledicami uporabe pod odobrenimi pogoji.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish whether the plant protection product meets the requirements provided for in Article 29, where used in accordance with Article 52, and under all realistic conditions of use, and the consequences of its use under the authorised conditions.
Naložbe v dajanje novih sredstev v promet je precejšnje, zlasti za mala in srednje velika podjetja, zato je potreben predvidljiv sistem odločanja, ki bo investicijskim podjetjem dal gotovost.
The investment in placing new products on the market is substantial, especially for SMEs, and a predictable decision making system is required to give certainty to the investing companies.
Spreminjanje pravil po vložitvi zahtevkov ni primerno in podjetja odvrača od naložb.
Changing the rules after the time of application is inappropriate and discourages investment by companies.
Predlagano besedilo v drugem delu zagotavlja pravno gotovost v primeru pravnih sporov.
The proposed wording in the second part ensures legal certainty in case of legal disputes.
Realne pogoje je mogoče oceniti in izmeriti ter lahko sodiščem omogočijo sojenje na podlagi merljivih dejstev.
Realistic conditions can be evaluated and measured and can allow courts to rule on the basis of measurable facts.
Člen 35, odstavek 1
Article 35, paragraph 1, subparagraph 3
Država članica, ki preučuje zahtevek, svojo oceno da na voljo drugim državam članicam v okviru istega območja, v katerem je bil zahtevek predložen .
The Member State examining the application shall make available its assessment to the other Member States within the same zone to which an application has been made .
Država članica, ki preučuje zahtevek, svojo oceno da na voljo drugim državam članicam.
The Member State examining the application shall make available its assessment to the other Member States.
Za dokončno vzpostavitev delujočega skupnega trga za fitofarmacevtska sredstva je potrebna registracija za vso EU.
EU-wide authorisation is required in order, finally, to establish a functioning internal market for plant protection products.
Zato je treba besedilo ustrezno spremeniti.
Changes should therefore also be made to the text.
Zadevne države članice ustrezno izdajo ali zavrnejo registracije na podlagi sklepov ocene države članice, ki preučuje zahtevek, kot je predvideno v členih 30 in 31.
The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 30 and 31.
Države članice pod enakimi pogoji odobrijo zadevno fitofarmacevtsko sredstvo, vključno z razvrstitvijo za namene Direktive 1999/45/ES, kot država članica, ki preučuje zahtevek.
The Member States shall authorise the plant protection product concerned under the same conditions, including classification for the purpose of Directive 1999/45/EC, as the Member State examining the application.
Če je fitofarmacevtsko sredstvo v neki državi članici že registrirano, druga država članica ne glede na določbe členov 30 in 31 odloča o tem, ali in pod kakšnimi pogoji bo zadevno fitofarmacevtsko sredstvo registrirala v roku 180 dni od prejetja zahtevka.
Without prejudice to Articles 30 and 31, where a plant protection product has already been authorised in one Member State , the other Member States shall decide whether and under which conditions to authorise the plant protection product concerned within 180 days of receiving an application .
Na podlagi poročevalčevega predloga spremembe 86 razdelitev na območja registracije ni primerna, saj razmere v predlaganih območjih pogosto niso primerljive.
Following the rapporteur's Amendment 86, the division into authorization zones is not appropriate as conditions in the proposed zones are often incomparable.
Obveščene države članice bi morale registracijo glede na svoje posebne nacionalne razmere v primernem 180-dnevnem roku potrditi, zavrniti ali omejiti.
Within a reasonable time period of 180 days, notified Member States should be obliged to confirm, reject or restrict the authorization pursuant their specific national situation.
Z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti se lahko določijo dodatni pogoji v zvezi z zahtevami iz člena 30(3).
By way of derogation from paragraph 2 and subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 30(3).
Z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti :
By way of derogation from paragraph 2 and subject to Community law:
(a) lahko države članice določijo za odobritev posebne pogoje in omejitve uporabe, če obstajajo utemeljeni znanstveni dokazi, da pogoji in omejitve iz prvotne registracije zaradi posebnih pogojev in vzorcev uporabe, prehranjevalnih navad ali drugih pomembnih okoliščin ne zadostujejo;
(a) Member States may subject approval to specific conditions and restriction of use, if there is substantiated, scientific evidence that due to specific conditions of use, use patterns, nutritional habits or other relevant circumstances the conditions and restriction in the original authorisation are not sufficient;
(b) se lahko določijo dodatni pogoji v zvezi z zahtevami iz člena 30(3).
(b) additional conditions may be imposed with respect to the requirements referred to in Article 30(3).
Uporaba in morebitne težave pri uporabi se lahko v državah članicah močno razlikujejo, celo v tistih, ki spadajo na isto območje.
Use and potential problems of use may vary considerably between Member States, even those belonging to the same zone.
Zato morajo imeti države članice možnost predvideti dodatne pogoje in omejitve uporabe.
Member States should therefore be able to foresee additional conditions and restrictions of use.
Člen 36, odstavek 1, pododstavek 2
Article 36, paragraph 1, subparagraph 2
V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica in ne sme biti daljše od štirih mesecev .
In that case, the twelve-month period shall be extended by the additional time period granted by the Member State , which may not exceed four months .
Opredelitev časovnih obdobij je potrebna za določitev postopkov.
Specifying the time periods is necessary in order to lay down the procedures.
Če zadevni državi članici ne dosežeta sporazuma v 90 dneh, država članica, ki preučuje zahtevek za registracijo, predloži zadevo Komisiji.
Where the Member States concerned do not reach agreement within 90 days the Member State examining the application for authorisation shall submit the matter to the Commission.