natgillin/translations-raw huggingface dataset:
Where active substances have been evaluated under a former stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation.
Če so bile aktivne snovi ocenjene v prejšnji fazi delovnega programa iz člena 8(2) Direktive 91/414/EGS, se te ocene, kjer je to smiselno, upoštevajo za namene te uredbe.
The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Articles 5, 6, and 10.
Država članica poročevalka ocenjuje in poroča samo o tistih aktivnih snoveh, za katere je vsaj en dosje določen kot popoln v skladu s členi 5, 6, in 10.
For dossiers concerning the same active substance not determined to be complete, it shall check whether the identity and impurities of the active substance in those dossiers are comparable to the identity and impurities of the active substance in the dossiers considered complete.
Pri dosjejih, ki zadevajo isto aktivno snov in ne veljajo pa za popolne, mora preveriti, ali sta identiteta in vsebnost nečistot aktivne snovi v teh dosjejih primerljivi z identiteto in vsebnostjo nečistot aktivne snovi v dosjejih, ki veljajo za popolne.
It shall record its views on this point in the draft assessment report.
Svoje poglede na to točko mora vnesti v osnutek ocenjevalnega poročila.
The rapporteur Member State shall take into consideration the information available on potentially dangerous effects in the other dossiers submitted by any notifier or by any third party in accordance with Article 11.
Država članica poročevalka mora upoštevati razpoložljive podatke o morebitnih nevarnih učinkih razvidnih iz drugih dosjejev, ki jih je predložil kateri koli prijavitelj ali tretja oseba, v skladu s členom 11.
General conditions for draft Assessment Reports
Splošni pogoji za osnutke ocenjevalnih poročil
The draft assessment report shall be submitted as far as possible in the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Osnutek ocenjevalnega poročila mora biti predložen, kolikor je mogoče, v obliki, priporočeni v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.
Država članica poročevalka mora od prijaviteljev zahtevati, naj posodobljen povzetek dosjeja posredujejo EFSA, drugim državam članicam in, na zahtevo, Komisiji, ob istem času, kot je osnutek ocenjevalnega poročila s strani poročevalca poslan EFSA.
The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof.
Države članice, Komisija ali EFSA lahko prek države članice poročevalke zahtevajo, da jim prijavitelj pošlje tudi posodobljen popoln dosje ali njegove dele.
The notifier shall provide any such updated dossier by the date specified in the request.
Prijavitelj mora poslati vsak tako posodobljen dosje do datuma, navedenega v zahtevi.
Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I
Posebni pogoji za osnutke ocenjevalnih poroči in priporočil Komisiji za aktivne snovi, navedene v delu A Priloge I
The rapporteur Member State shall send the draft assessment report to the EFSA as quickly as possible, and 12 months from the date of expiry of the time limit provided for in Article 12(a) at the latest.
Država članica poročevalka mora čim prej poslati osnutek ocenjevalnega poročila EFSA, najkasneje pa v 12 mesecih od izteka roka, predpisanega v členu 12(a).
The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.
Država članica poročevalka mora v osnutek ocenjevalnega poročila vnesti sklicevanje na vsak poskus ali študijo v zvezi z vsako točko Priloge II (del A ali del B, kot je primerno) k Direktivi 91/414/EGS ter za vsako točko Priloge III (del A ali del B, kot je primerno) k navedeni direktivi, na katere se je oprla pri ocenjevanju.
That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name, and if any, the claim made by the holder or notifier for data protection.
Sklicevanje mora biti napisano v obliki seznama poročil o poskusih in študijah, vključno z naslovom, avtorjem(-ji), datumom poročila o poskusu ali študiji in datumom objave, standardom, po katerem je poskus ali študija potekal(-a), imenom imetnika, ter, če obstaja, zahtevo po varstvu podatkov, ki jo je podal imetnik dovoljenja ali prijavitelj.
At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:
Istočasno z oddajo ocenjevalnega poročila EFSA, kot je določeno v odstavku 1, mora država članica poročevalka Komisiji priporočiti:
either to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the proposed conditions for inclusion; such conditions:
ali naj vključi aktivno snov v Prilogo I k Direktivi 91/414/EGS, ter navesti, kjer je primerno, predlagane pogoje za vključitev; ti pogoji:
may include the time limit for such inclusion:
lahko vsebujejo rok za vključitev;
shall state whether any information is required, whether such additional information is included in the tests and studies referred to in Article 9(1)(c) of this Regulation and if so, the probable timetable for the provision of such information; or
morajo določati, ali se zahtevajo kakršni koli podatki, ali so taki dodatni podatki vključeni v poskuse in študije iz člena 9(1)(c) te uredbe, in če je tako, možen časovni okvir za posredovanje teh podatkov; ali
not to include the active substance in Annex I to Directive 91/414/EEC, stating the proposed reasons for the non-inclusion.
naj aktivne snovi ne vključi v Prilogo I k Direktivi 91/414/EGS, z navedbo predlaganih razlogov za nevključitev.
In addition to the conditions for inclusion proposed under paragraph 2(a) of this Article, the rapporteur Member State may indicate if it has identified, for the proposed limited range of representative uses mentioned in the dossier, any information missing from the dossier which may be required by Member States as confirmatory information when they come to grant authorisations under Article 4 of Directive 91/414/EEC for plant protection products containing that active substance.
Poleg pogojev za vključitev, predlaganih po odstavku 2(a) tega člena, lahko država članica poročevalka navede, ali je za predlagan omejen obseg reprezentativne uporabe, omenjen v dosjeju, določila kateri koli podatek, ki manjka v dosjeju, ki pa bi ga lahko države članice zahtevale kot potrdilni podatek, pri registraciji fitofarmacevtskih sredstev po členu 4 Direktive 91/414/EGS, ki vsebujejo to aktivno snov.
Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I
Posebni pogoji za osnutke ocenjevalnih poročil in priporočil Komisiji za aktivne snovi, navedene v delih B do G Priloge I
The rapporteur Member State shall send a draft assessment report to the EFSA as quickly as possible, and at the latest 12 months from the date the dossier was determined to be complete in accordance with Article 18(2).
Država članica poročevalka mora čim prej poslati osnutek ocenjevalnega poročila EFSA, najkasneje pa v 12 mesecih od datuma, ko je bil dosje opredeljen kot popoln v skladu s členom 18(2).
That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name and, if any, the claim made by the holder or notifier for data protection.
Sklicevanje mora biti napisano v obliki seznama poročil o poskusih in študijah, vključno z naslovom, avtorjem(-ji), datumom poročila o poskusu ali študiji in datumom objave, standardom, po katerem je poskus ali študija potekal(-a), imenom imetnika, ter, če obstaja, zahtevo po varstvu podatkov, ki jo je podal imetnik dovoljenja ali prijavitelj.
either to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the inclusion;
ali naj vključi aktivno snov v Prilogo I k Direktivi 91/414/EGS, ter navesti razloge za vključitev;
or not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.
ali naj aktivne snovi ne vključi v Prilogo I k Direktivi 91/414/EGS, z navedbo razlogov za nevključitev.
Replacement of rapporteur Member State
Zamenjava države članice poročevalke
A rapporteur Member State shall inform the Commission and the EFSA as soon as it becomes clear that it will be unable to comply with the time limits set out in Articles 21(1) and 22(1) for the submission of the draft assessment report to the EFSA and give the reasons for the delay.
Država članica poročevalka mora Komisijo in EFSA obvestiti takoj, ko postane jasno, da se ne bo več mogla držati rokov, določenih v členih 21(1) in 22(1) za predložitev osnutka ocenjevalnega poročila EFSA, in navesti razloge za zamudo.
It may be decided to replace a rapporteur Member State for a particular active substance by another Member State where:
Državo članico poročevalko za določeno aktivno snov, lahko nadomesti druga država članica, če:
during the assessment and evaluation provided for in Articles 15, 16, 17 and 19 it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs; or
med ocenjevanjem in vrednotenjem, predvidenim v členih 15, 16, 17 in 19 postane očitno, da obstaja nesorazmerje med odgovornostmi, ki jih je kot poročevalka prevzela ta država članica, in delom, ki ga še mora opraviti ali ga je dejansko opravila; ali
it is clear that a Member State is unable to fulfil its obligations under this Regulation.
je jasno, da država članica ne more izpolniti obveznosti iz te uredbe.
Such replacement shall be decided in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
O takšni zamenjavi se odloča v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
Where it has been decided to replace a rapporteur Member State the original rapporteur Member State shall immediately after such a decision has been taken inform the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.
Če je bila sprejeta odločitev o zamenjavi države članice poročevalke, mora prvotna država članica poročevalka takoj po sprejetju take odločitve o tem obvestiti prijavitelje ter na novo državo članico poročevalko prenesti vso korespondenco in podatke, ki jih je v zvezi z zadevno aktivno snovjo prejela kot država članica poročevalka.
The original Member State shall return to the notifier the part of the fee referred to in Article 30 which has not been used.
Izvirna država članica poročevalka mora prijavitelju vrniti del denarnega nadomestila iz člena 30, ki še ni bil uporabljen.
The newly designated rapporteur Member State may require the payment of a further fee in accordance with Article 30.
Nova država članica poročevalka lahko v skladu s členom 30 zahteva plačilo dodatnega nadomestila.
Evaluation by the EFSA
Ocenjevanje s strani EFSA
The EFSA shall, within 30 days of the date of receipt of the draft assessment report as provided for in Article 21(1) or Article 22(1) of this Regulation, check that it clearly complies with the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
EFSA mora v 30 dneh od prejetja osnutka ocenjevalnega poročila, kot določata člena 21(1) ali 22(1) te uredbe, preveriti, ali ta jasno ustreza obliki, priporočeni v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
In exceptional cases where the draft assessment report clearly does not fulfil those requirements the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report which shall not exceed three months.
V izjemnih primerih, če osnutek ocenjevalnega poročila očitno ne izpolnjuje teh zahtev, se mora Komisija uskladiti z EFSA in državo članico poročevalko glede roka za ponovno predložitev spremenjenega poročila, ki pa ne sme biti daljši od treh mesecev.
The EFSA shall circulate the draft assessment report to the other Member States and to the Commission and may organise a consultation of experts including the rapporteur Member State.
EFSA mora razposlati osnutek ocenjevalnega poročila drugim državam članicam in Komisiji ter lahko pripravi posvetovanja strokovnjakov, vključno z državo članico poročevalko.
The EFSA may consult some or all of the notifiers of active substances referred to in Annex I on the draft assessment report or parts thereof on the relevant active substances.
EFSA se lahko posvetuje z nekaterimi ali vsemi prijavitelji o aktivnih snoveh iz Priloge I glede osnutka ocenjevalnega poročila ali njegovih delov o ustreznih aktivnih snoveh.
Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted by the EFSA after receipt of the draft assessment report referred to in paragraph 1 of this Article.
Brez poseganja v člen 7 Direktive 91/414/EGS, EFSA ne bo sprejela predložitve novih študij po prejetju osnutka ocenjevalnega poročila iz odstavka 1 tega člena.
However, the rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified time limits further data considered by the rapporteur Member State or the EFSA necessary to clarify the dossier.
Država članica poročevalka pa vseeno lahko, v dogovoru z EFSA, zahteva od prijaviteljev, naj ji v določenem roku predložijo dodatne podatke, ki se državi članici poročevalki ali EFSA zdijo nujni za razjasnitev dosjeja.
The EFSA shall make available at specific request or keep available for consultation by any person the following:
EFSA mora na posebno zahtevo ali za posvetovanja katere koli osebe omogočiti dostop do:
the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;
osnutka ocenjevalnega poročila, razen delov, ki so bili sprejeti kot zaupni v skladu s členom 14 Direktive 91/414/EGS;
the list of any data required for the evaluation of the possible inclusion of the active substance in Annex I to Directive 91/414/EEC, as finalised by the EFSA.
seznama vseh podatkov, potrebnih za oceno morebitne vključitve aktivne snovi v Prilogo I k Direktivi 91/414/EGS, kot ga je dokončno oblikovala EFSA.
The EFSA shall evaluate the draft assessment report and submit its evaluation to the Commission on whether the active substance may be expected to meet the requirements of Article 5(1) of Directive 91/414/EEC at the latest one year from the date on which it has received both the dossier from the notifier, under Article 15(3) of this Regulation, and also the draft assessment report checked for compliance in accordance with paragraph 1 of this Article.
EFSA bo ocenila osnutek ocenjevalnega poročila ter svojo oceno o tem, ali se lahko pričakuje, da bo aktivna snov izpolnila zahteve iz člena 5(1) Direktive 91/414/EGS, poslala Komisiji najkasneje eno leto od datuma, ko je prejela tako dosje od prijavitelja, po členu 15(3) te uredbe, kot tudi osnutek ocenjevalnega poročila, katerega ustreznost je bila preverjena v skladu z odstavkom 1 tega člena.
Where appropriate, the EFSA shall give its evaluation of the available options claimed to meet the requirements of Article 5(1) of Directive 91/414/EEC and any data requirements identified.
Kjer je primerno, bo EFSA podala svojo oceno o dosegljivih možnostih za izpolnitev zahtev člena 5(1) Direktive 91/414/EGS in katerih koli določenih podatkovnih zahtev.
The Commission and the EFSA shall agree on a schedule for the submission of the evaluation in order to facilitate the planning of the work.
Komisija in EFSA se bosta dogovorili glede načrta predložitve ocene, da bi tako pospešili načrtovanje dela.
The Commission and the EFSA shall also agree on the format of the evaluation.
Komisija in EFSA se bosta prav tako sporazumeli o obliki ocene.
PRESENTATION OF A DRAFT DIRECTIVE OR DRAFT DECISION CONCERNING ACTIVE SUBSTANCES AND FINALISED REVIEW REPORT
PREDSTAVITEV OSNUTKA DIREKTIVE ALI OSNUTKA ODLOČBE GLEDE AKTIVNIH SNOVI TER ZAKLJUČNO POROČILO O PREGLEDU
Presentation of a draft Directive or draft Decision
Predstavitev osnutka direktive ali osnutka odločbe
The Commission shall present a draft review report at the latest four months from the date of receipt of the EFSA evaluation provided for in Article 24(6)
Komisija bo predstavila osnutek poročila o pregledu najkasneje v štirih mesecih od datuma prejetja ocene EFSA, predpisane v členu 24(6).
Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, and on the basis of the finalised review report provided for in Article 26 of this Regulation, the Commission shall present to the Standing Committee on the Food Chain and Animal Health:
Brez poseganja v kateri koli predlog, ki ga lahko vloži za spremembo Priloge k Direktivi 79/117/EGS, ter na podlagi zaključenega poročila o pregledu, predvidenega v členu 26 te uredbe, bo Komisija Stalnemu odboru za prehransko verigo in zdravstveno varstvo živali predstavila:
a draft Directive to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the conditions for inclusion; such conditions may include the time limit for such inclusion; or
osnutek direktive za vključitev aktivne snovi v Prilogo I k Direktivi 91/414/EGS, z navedbo, kjer je to potrebno, pogojev za vključitev; ti pogoji lahko vsebujejo rok za takšno vključitev; ali
a draft Decision addressed to the Member States pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include that active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion and requiring the Member States to withdraw the authorisations of plant protection products containing the active substance.
osnutek odločbe, naslovljene na države članice v skladu s četrtim pododstavkom člena 8(2) Direktive 91/414/EGS, o nevključitvi te aktivne snovi v Prilogo I k Direktivi 91/414/EGS, z navedbo razlogov za nevključitev ter zahtevo državam članicam, naj umaknejo registracije za fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Direktiva ali odločba morata biti sprejeti v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
In addition to the conditions for inclusion proposed under paragraph 2(a), the Commission may indicate if it has identified any information missing from the dossier which may be required by Member States when they come to grant authorisations under Article 4 of Directive 91/414/EEC.
Poleg pogojev za vključitev, predlaganih po odstavku 2(a), lahko Komisija navede, ali je odkrila kateri koli manjkajoč podatek v dosjeju, ki bi ga lahko države članice zahtevale ob registraciji po členu 4 Direktive 91/414/EGS.
Finalised review report
Zaključeno poročilo o pregledu
The conclusions of the Standing Committee on the Food Chain and Animal Health, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made publicly available.
Zaključki Stalnega odbora za prehransko verigo in zdravstveno varstvo živali, pri čemer so izključeni deli, ki se nanašajo na podatke v dosjejih, ki veljajo za zaupne v skladu s členom 14 Direktive 91/414/EGS, morajo biti javno dostopni.
SUSPENSION OF TIME LIMITS, MEASURES TO BE TAKEN BY MEMBER STATES AND INTERIM PROGRESS REPORTS
ODPRAVA ROKOV, UKREPI, KI JIH MORAJO SPREJETI DRŽAVE ČLANICE IN ZAČASNA POROČILA O NAPREDKU
Suspension of time limits
Odprava rokov
Where, in respect of an active substance listed in Annex I to this Regulation, the Commission presents a proposal for a total prohibition by way of a draft Council act based on Article 6(3) of Directive 79/117/EEC, the time limits provided for in this Regulation shall be suspended while the Council considers that proposal.
Če Komisija v zvezi z aktivno snovjo, navedeno v Prilogi I k tej uredbi, poda predlog popolne prepovedi v obliki osnutka akta Sveta, temelječega na členu 6(3) Direktive 79/117/EGS, se roki, predpisani s to uredbo, odpravijo v času, ko Svet preučuje ta predlog.
Where the Council adopts an amendment to the Annex to Directive 79/117/EEC requiring the total prohibition of that active substance, the procedure under this Regulation shall be terminated for that active substance.
Če Svet sprejme spremembo k Prilogi Direktive 79/117/EGS, s katero zahteva popolno prepoved te aktivne snovi, se postopek po tej uredbi za to aktivno snov neha.
Measures taken by Member States
Ukrepi držav članic
Any Member State which, on the basis of information contained in the dossiers referred to in Articles 5 to 10 or in the draft assessment report concerning an active substance referred to in Articles 19 to 22, intends taking action to withdraw that active substance from the market or to restrict severely the use of a plant protection product containing that active substance, shall, as soon as possible, inform the Commission, the EFSA, the other Member States and the notifiers giving the reasons for its intended action.
Vsaka država članica, ki na podlagi podatkov v dosjejih, na katere se nanašajo členi 5 do 10, ali v osnutku ocenjevalnega poročila, ki zadeva aktivno snov, na katero se nanašajo členi 19 do 22, namerava sprejeti ukrepe za umik te aktivne snovi s trga ali pa močno omejiti uporabo fitofarmacevtskega sredstva, ki vsebuje to aktivno snov, mora o razlogih za to dejanje čim prej obvestiti Komisijo, EFSA, druge države članice ter prijavitelje.
Interim progress report
Začasno poročilo o napredku
All Member States shall submit to the Commission and the EFSA a report of their progress on the evaluation of the active substances for which they are rapporteur.
Vse države članice morajo Komisiji in EFSA predložiti poročilo o svojem napredku pri ocenjevanju aktivnih snovi, za katere so določene kot poročevalke.
Such report shall be submitted by:
Poročilo mora biti poslano do:
30 November 2005 for the active substances listed in Part A of Annex I;
novembra 2005 za aktivne snovi, navedene v delu A Priloge I;
30 November 2006 for the active substances listed in Parts B to G of Annex I.
novembra 2006 za aktivne snovi, navedene v delih B do G Priloge I.
FEES AND OTHER CHARGES
PRISTOJBINE IN DRUGA PLAČILA
For active substances listed in Annex I Member States may establish a regime obliging the notifiers to pay a fee or charge for the administrative treatment and the evaluation of dossiers.
Za aktivne snovi, navedene v Prilogi I, lahko države članice oblikujejo ureditev, s katero zavežejo prijavitelje k plačilu pristojbine ali dajatve za upravno obravnavo ter ocenjevanje dosjejev.