natgillin/translations-raw huggingface dataset:
a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to that Directive may be met.
omejen obseg reprezentativnih uporab aktivne snovi, glede na katere bodo podatki, ki jih v dosjeju posreduje prijavitelj, pokazali, da je za enega ali več pripravkov mogoče izpolniti zahteve iz člena 5 Direktive 91/414/EGS za vključitev aktivne snovi v Prilogo I navedene direktive.
When requested by the rapporteur Member State as provided for in Article 20(2) to circulate the updated summary dossier or where relevant the updated complete dossier or parts thereof the notifier shall do this at the latest one month from the date of receipt of such a request.
Če država članica poročevalka, kot je predpisano v členu 20(2), zahteva posredovanje posodobljenega povzetka dosjeja ali, če je potrebno, popolnega dosjeja ali njegovih delov, mora prijavitelj to storiti najkasneje mesec dni po prejetju takšne zahteve.
Dossiers for active substances submitted under Directive 98/8/EC
Dosjeji za aktivne snovi, predloženi v skladu z Direktivo 98/8/ES
By derogation from Articles 5 and 6, where an active substance has been notified under Directive 98/8/EC the notifier may submit:
Če je aktivna snov prijavljena v skladu z Direktivo 98/8/ES, lahko prijavitelj z odstopanjem od členov 5 in 6 priloži:
a copy of the dossier submitted under Directive 98/8/EC;
kopijo dosjeja, predloženega po Direktivi 98/8/ES;
any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of that Directive.
vse dodatne podatke, na katere se nanašata Prilogi II in III k Direktivi 91/414/EGS, potrebne za utemeljitev vključitve aktivne snovi v Prilogo I k navedeni direktivi ob upoštevanju uporabe, ki spada v področje navedene direktive.
Dossiers for active substances submitted under Regulation (EC) No 1490/2002
Dosjeji za aktivne snovi, predloženi v skladu z Uredbo (ES) št. 1490/2002
Where a dossier has been submitted under Regulation (EC) No 1490/2002, the person who submitted that dossier may submit, together with the further dossier submitted under this Regulation:
Če je bil dosje predložen v skladu z Uredbo (ES) št. 1490/2002, lahko oseba, ki ga je predložila, skupaj z nadaljnjim dosjejem, predloženim po tej uredbi, poda:
a reference to the dossier submitted under Regulation (EC) No 1490/2002;
sklicevanje na dosje, predloženo po Uredbi (ES) št. 1490/2002;
any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of this Regulation.
katere koli dodatne podatke, na katere se nanašata Prilogi II in III k Direktivi 91/414/EGS, potrebne za utemeljitev vključitve aktivne snovi v Prilogo I k navedeni direktivi ob upoštevanju uporabe, ki spada v področje navedene direktive.
Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I
Posebni pogoji za predložitev dosjejev za aktivne snovi, navedene v delu A Priloge I
Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable):
Če dosje zadeva aktivno snov, navedeno v delu A Priloge I, mora prijavitelj, poleg podatkov, zahtevanih po členu 5 in členu 6(2), predložiti naslednje podatke, ki zadevajo aktivno snov in fitofarmacevtsko sredstvo (kjer je primerno):
all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used;
vse razpoložljive podatke o možnem tveganju za zdravje ljudi in živali ter okolje, vključno s podatki, omenjenim v literaturi, ter z navedbo podatkovnih baz, v katerih je prijavitelj iskal podatke, skupaj z iskalnimi gesli;
available assessment reports from any OECD country;
razpoložljiva poročila o ocenjevanju iz katere koli države, članice OECD;
for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion.
za vse poskuse in študije, ki še potekajo in še niso popolnoma končani, podatke o teh poskusih in študijah ter predviden datum zaključka.
The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1.
Dosje mora fizično vsebovati poročila o posameznih poskusih in študijah, z vsemi podatki iz odstavka 1.
Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2).
Vsaka država članica, ki je v vlogi poročevalke ali prejema kopije po členu 20(2), mora določiti število kopij dosjeja, ki jih mora predložiti prijavitelj.
The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Pri obliki dosjeja se mora upoštevati priporočila, podana v skladu s postopki iz člena 19 Direktive 91/414/EGS.
Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I
Posebni pogoji za predložitev dosjejev za aktivne snovi, navedene v delih B do G Priloge I
Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier.
Če dosje zadeva aktivno snov, navedeno v delih B do G Priloge I, mora prijavitelj predložiti dosje in povzetek dosjeja.
The notifier(s) shall include in the summarydossier:
Prijavitelj(-i) mora(-jo) v povzetek dosjeja vključiti:
the information required under Article 5 and Article 6(2) of this Regulation;
podatke, zahtevane po členu 5 in členu 6(2) te uredbe;
for 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, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies;
za vsako točko Priloge II (del A ali del B, kot je primerno) k Direktivi 91/414/EGS in za vsako točko Priloge III (del A ali del B, kot je primerno) k navedeni direktivi, povzetke in rezultate poskusov in študij ter ime osebe ali ustanove, ki je te poskuse in študije izvedla;
a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation.
prijavitelj mora izpolniti kontrolni list, ter prikazati, da je dosje popoln v skladu s členom 18 te uredbe.
The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC.
Poskusi in študije iz odstavka 2(b) tega člena morajo biti tisti, ki so pomembni za ocenjevanje meril iz člena 5 Direktive 91/414/EGS za enega ali več pripravkov za uporabo, upoštevajoč dejstvo, da lahko razlike v podatkih v dosjeju glede podatkov, zahtevanih po Prilogi II Direktive 91/414/EGS, ki izhajajo iz predlaganega omejenega obsega reprezentativnih uporab aktivne snovi, pripeljejo do omejitev pri vključevanju v Prilogo I Direktive 91/414/EGS.
The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2.
Popoln dosje mora fizično vsebovati posamezna poročila o poskusih in študijah, ki zadevajo vse podatke, na katere se nanaša točka (b) ter drugi pododstavek odstavka 2.
Each Member State shall specify the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.
Vsaka država članica mora določiti število kopij in obliko povzetka dosjeja ter popolnega dosjeja, ki jih morajo predložiti prijavitelji.
In defining the format of the complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Pri določanju oblike popolnega dosjeja oziroma povzetkov dosjejev morajo države članice upoštevati priporočila, določena v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
Submission of information by third parties
Predložitev podatkov s strani tretjih oseb
Any natural or legal person wishing to submit relevant information which may contribute to the evaluation of an active substance listed in Annex I, in particular with regard to the potentially dangerous effects of that substance or its residues on human and animal health and on the environment, shall do so by the relevant time limit set out in Article 12.
Vsaka fizična ali pravna oseba, ki želi predložiti pomembne podatke, ki bi lahko prispevali k oceni aktivne snovi, navedene v Prilogi I, zlasti glede potencialno nevarnih učinkov te snovi ali njenih ostankov na zdravje ljudi in živali ter okolje, mora to storiti v ustreznem roku, določenem v členu 12.
Such information shall be submitted to the rapporteur Member State and the EFSA.
Takšne podatke lahko predloži državi članici poročevalki ali EFSA.
When requested by the rapporteur Member State such person shall also submit that information to the other Member States at the latest one month from the date of receipt of such a request.
Na zahtevo države članice poročevalke mora ta oseba omenjene podatke posredovati tudi drugim državam članicam, in sicer najkasneje mesec dni od dne, ko je prejela zahtevo.
Time limits for submission of dossiers
Roki za predložitev dosjejev
The notifier(s) shall submit the dossier to the relevant rapporteur Member State by:
Prijavitelj(-i) mora(-jo) dosje predložiti ustrezni državi članici poročevalki do:
30 June 2005 at the latest for the active substances listed in Part A of Annex I;
najkasneje 30. junija 2005 za aktivne snovi, navedene v delu A Priloge I;
30 November 2005 at the latest for the active substances listed in Parts B to G of Annex I.
najkasneje 30. novembra 2005 za aktivne snovi, navedene v delih B do G Priloge I.
Non-submission of dossiers
Nepredložitev dosjejev
Where the notifier does not submit the dossier or any part thereof within the relevant time limit set out in Article 12, the rapporteur Member State shall inform the Commission and the EFSA within two months of the date of expiry of the time limit, giving any justification for the delay provided by the notifiers.
Če prijavitelj dosjeja ali katerega koli njegovega dela ne predloži v ustreznem roku, določenem v členu 12, mora država članica poročevalka o tem obvestiti Komisijo in EFSA v dveh mesecih od dneva poteka roka in ob tem posredovati vsako obrazložitev zamude, ki ji jo posredujejo prijavitelji.
On the basis of the information submitted by the rapporteur Member State in accordance with paragraph 1, the Commission shall determine whether the notifier has demonstrated that the delay in the submission of the dossier was caused by force majeure.
Komisija bo na podlagi podatkov, ki jih pridobi od države članice poročevalke v skladu z odstavkom 1, odločila, ali je prijavitelj dokazal, da je zamuda pri predložitvi nastala zaradi višje sile.
In that case, it shall establish a new time limit for the submission of a dossier fulfilling the relevant requirements of Articles 5, 6, 9, and 10 of this Regulation in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
V tem primeru bo določila nov rok za predložitev dosjeja ob izpolnjevanju zahtev iz členov 5, 6, 9, in 10 te uredbe v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive an active substance for which no dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second subparagraph of paragraph 2 of this Article.
Komisija bo, kot je predpisano v četrtem pododstavku člena 8(2) Direktive 91/414/EGS, odločila, da v Prilogo I k navedeni direktivi ne bo vključila aktivnih snovi, za katere dosje ni bil predložen v roku, določenem v členu 12 te uredbe ali drugem pododstavku odstavka 2 tega člena.
Replacement or withdrawal of notifier
Zamenjava ali umik prijavitelja
If a notifier decides to end its participation in the programme of work for an active substance, it shall immediately inform the rapporteur Member State, the Commission, the EFSA and all other notifiers of the active substance concerned of its decision, giving the reasons.
Če se prijavitelj odloči, da ne bo več sodeloval v delovnem programu za aktivne snovi, mora o tem nemudoma obvestiti državo članico poročevalko, Komisijo, EFSA in druge prijavitelje zadevne aktivne snovi, ter navesti razloge za svojo odločitev.
Where a notifier ends its participation or fails to fulfil its obligations under this Regulation, the procedures provided for in Articles 15 to 24 shall be terminated as regards its dossier.
Če prijavitelj zaključi svoje sodelovanje ali ne izpolni svojih obveznosti po tej uredbi, se postopki v zvezi s tem dosjejem, ki jih predpisujejo členi 15 do 24, ustavijo.
If a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the programme of work under this Regulation, the notifier and such other producer shall inform the rapporteur Member State, the Commission and the EFSA by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.
Če se prijavitelj strinja z drugim proizvajalcem, da bo prijavitelj zamenjan za namene nadaljnjega sodelovanja v delovnem programu po tej uredbi, morata prijavitelj in ta drugi proizvajalec obvestiti državo članico poročevalko, Komisijo in EFSA, in sicer s skupno izjavo, v kateri se strinjata, da bo ta drugi proizvajalec zamenjal prvotnega prijavitelja pri izvajanju prijaviteljevih dolžnosti v skladu z ustreznimi določbami členov 4, 5, 6, 9, 10, 12 in 24.
They shall ensure that the other notifiers for the substance concerned are informed at the same time.
Prav tako morata poskrbeti, da bodo o tem obveščeni tudi drugi prijavitelji zadevne snovi.
The other producer in this case shall be jointly liable with the original notifier for any fees remaining payable in relation to the notifier's application under the regime established by Member States pursuant to Article 30.
Drugi proizvajalec je v tem primeru skupaj s prvotnim prijaviteljem odgovoren za vse neplačane pristojbine v zvezi s prijaviteljevo vlogo na način, ki ga skladno s členom 30 določijo države članice.
If all notifiers for an active substance end their participation in the programme of work a Member State may choose to act as notifier for the purposes of further participation in the programme of work.
Če vsi prijavitelji aktivne snovi zaključijo svojo udeležbo v delovnem programu, se država članica lahko odloči delovati kot prijavitelji za namen nadaljnjega sodelovanja v delovnem programu.
Any Member State wishing to act as a notifier shall inform the rapporteur Member State, the Commission and the EFSA at the latest one month from the date of being informed that all notifiers have decided to end their participation and shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.
Vsaka država članica, ki želi delovati kot prijavitelj, mora o tem obvestiti državo članico poročevalko, Komisijo in EFSA najkasneje mesec dni od dne, ko je bila obveščena, da so se vsi prijavitelji odločili zaključiti svojo udeležbo, ter zamenjati izvirnega prijavitelja pri izvajanju prijaviteljevih dolžnosti v skladu z ustreznimi določbami členov 4, 5, 6, 9, 10, 12 in 24.
All information submitted shall remain available to the rapporteur Member States, the Commission and EFSA
Vsi podani podatki ostanejo dostopni državi članici poročevalki, Komisiji in EFSA.
EVALUATIONS OF DOSSIERS
OCENJEVANJE DOSJEJEV
General Conditions for evaluations of dossiers
Splošni pogoji ocenjevanja dosjejev
Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it.
Brez poseganja v člen 18 mora država članica poročevalka oceniti vse prejete dosjeje.
Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation.
Brez poseganja v člen 7 Direktive 91/414/EGS, država članica poročevalka ne sme med ocenjevanjem sprejeti vložitve novih študij, razen v primerih, določenih v členu 9(1)(c) te uredbe.
However, the rapporteur Member State may request the notifier to submit further data which are necessary to clarify the dossier.
Država članica poročevalka pa vendar lahko zahteva od prijavitelja, naj ji posreduje dodatne podatke, potrebne za razjasnitev dosjeja.
When doing so the rapporteur Member State shall set a time limit within which the information shall be provided.
V tem primeru mora država članica poročevalka določiti rok, v katerem mora prijavitelj posredovati podatke.
The time limit shall not affect the time limit for the submission of the draft assessment report by the rapporteur Member State to the EFSA as provided for in Article 21(1) or Article 22(1).
Ta rok ne sme posegati v rok za oddajo osnutka ocenjevalnega poročila, ki ga mora država članica podati EFSA, kot je določeno v členu 21(1) ali členu 22(1).
The rapporteur Member State may, from the start of the evaluation of the dossier:
Država članica poročevalka lahko od dneva začetka ocenjevanja dosjeja:
consult with experts from the EFSA;
za nasvet zaprosi strokovnjake EFSA;
request additional technical or scientific information from other Member States to assist in the evaluation.
zahteva dodatne tehnične ali znanstvene podatke od drugih držav članic, za pomoč pri v ocenjevanju.
Notifiers may seek specific advice from the rapporteur Member State.
Prijavitelji lahko državo članico poročevalko zaprosijo za poseben nasvet.
Cooperation between Member States
Sodelovanje med državami članicami
The rapporteur Member States shall cooperate in the evaluation within each group set out in Annex I and shall organise such cooperation in the most effective and efficient way.
Država članica poročevalka sodeluje pri ocenjevanju znotraj vsake skupine, določene v Prilogi I, ter mora čim bolj učinkovito organizirati takšno sodelovanje.
The rapporteur Member State identified within each group in Annex I as the ‘lead rapporteur’ shall take a lead in organising that cooperation and in organising the provision of advice to notifiers where it concerns matters of general interest to the other Member States concerned.
Država članica poročevalka, ki je v vsaki skupini v Prilogi I določena kot „vodilna poročevalka“, mora prevzeti vodenje organizacije tega sodelovanja ter svetovanja prijaviteljem, kjer to zadeva splošen interes ostalih zadevnih držav članic.
Specific condition for evaluations of active substances listed in Part A of Annex I
Posebni pogoji za ocenjevanje aktivnih snovi, navedenih v delu A Priloge I
Where possible and where it does not affect the time limit for the submission of the draft assessment report as provided for in Article 21(1), the rapporteur Member State shall evaluate further information identified under Article 9(1)(c) subsequently provided by the notifier.
Država članica poročevalka oceni nadaljnje podatke, ki jih je naknadno posredoval prijavitelj in so določeni v členu 9(1)(c), če je to možno in če ne vpliva na rok za oddajo osnutka ocenjevalnega poročila, kot je predpisano v členu 21(1).
Completeness check of dossiers for substances listed in Parts B to G of Annex I
Pregled popolnosti dosjejev za snovi, navedene v delih B do G Priloge I
The rapporteur Member State shall assess the checklists provided by the notifiers in accordance with Article 10(2)(c).
Država članica poročevalka oceni kontrolne sezname, ki jih posredujejo prijavitelji v skladu s členom 10(2)(c).
The rapporteur Member State shall at the latest three months from the date of receipt of all dossiers for an active substance report to the Commission on the completeness of the dossiers.
Država članica poročevalka mora o popolnosti dosjejev poročati Komisiji najkasneje v treh mesecih od dneva prejetja vseh dosjejev za aktivno snov.
For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Articles 15 and 19, unless the Commission informs the rapporteur Member State, within two months of the date of receipt of the report of the rapporteur Member State on completeness, that it does not consider the dossier to be complete.
Za aktivne snovi, za katere eden ali več dosjejev veljajo za popolne, država članica poročevalka opravi ocenjevanje iz členov 15 in 19, razen če Komisija obvesti državo članico poročevalko v dveh mesecih od datuma prejetja poročila države članice poročevalke o popolnosti dosjejev, da dosjeja nima za popolnega.
For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Articles 5, 6 and 10, the Commission shall, within three months from the date of the receipt of the report of the rapporteur Member State on completeness, refer such a report to the Standing Committee for the Food Chain and Animal Health.
Za aktivne snovi, za katere država članica poročevalka ali Komisija menita, da noben od prispelih dosjejev ni popoln v smislu členov 5, 6 in 10, mora Komisija v treh mesecih od datuma prejetja poročila države članice poročevalke o popolnosti dosjejev, posredovati takšno poročilo Stalnemu odboru za prehransko verigo in zdravstveno varstvo živali.
In accordance with the procedure referred to in Article 19 of Directive 91/414/EEC it shall be decided whether a dossier is to be considered complete within the meaning of Articles 5, 6 and 10.
V skladu s postopkom iz člena 19 Direktive 91/414/EGS je treba določiti, ali se dosje šteje za popolnega v smislu členov 5, 6 in 10.
The Commission shall decide, as provided for in the fourth subparagraph of Article 8 (2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second sub-paragraph of Article 13 (2).
Komisija bo odločila, kot je predvideno v četrtem pododstavku člena 8(2) Direktive 91/414/EGS, da v Prilogo I k Direktivi 91/414/EGS ne bo vključila aktivnih snovi, za katere ni bil predložen noben popoln dosje v roku, predpisanem v členu 12 te uredbe oziroma v drugem pododstavku člena 13(2).
Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I
Posebni pogoji za ocenjevanje dosjejev za snovi, navedene v delih B do G Priloge I
Where active substances listed in Part D of Annex I to this Regulation have been evaluated under Directive 98/8/EC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation
Če so bile aktivne snovi, navedene v delu D Priloge I k tej uredbi, ocenjene po Direktivi 98/8/ES, se te ocene, kjer je to smiselno, upoštevajo za namene te uredbe.