natgillin/translations-raw huggingface dataset:
Within 12 months from the date of publication of the completeness decision, the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to fulfil the conditions provided for in Article 5 of Directive 91/414/EEC, hereinafter referred to as ‘draft assessment report’.
V dvanajstih mesecih po datumu objave sklepa o popolnosti država članica poročevalka pripravi in predloži Komisiji poročilo in pošlje kopijo Agenciji (v nadaljnjem besedilu: osnutek poročila o oceni), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnjevala pogoje iz člena 5 Direktive 91/414/EGS.
It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to immediately forward to the Authority, the other Member States and the Commission the updated dossiers, where applicable.
Hkrati obvesti vlagatelja, da je bil predložen osnutek poročila o oceni, in od njega zahteva, da, kadar je to primerno, Agenciji, drugim državam članicam in Komisiji nemudoma posreduje posodobljeno dokumentacijo.
Where the rapporteur Member State needs additional information, it shall request it from the applicant setting a period of up to 6 months for it to be supplied.
Če država članica poročevalka potrebuje dodatne informacije, vlagatelju določi rok največ šestih mesecev za njihovo predložitev.
The rapporteur Member State shall inform the Commission and the Authority.
O tem obvesti Komisijo in Agencijo.
In its assessment the rapporteur Member State shall only take into account information which was requested and submitted within the period granted.
V svoji oceni država članica poročevalka upošteva le informacije, zahtevane in predložene v odobrenem obdobju.
In cases where the rapporteur Member State requests additional information, the 12-month period provided for in paragraph 1 for the submission of the draft assessment report shall be extended by the period granted by the rapporteur Member State for the submission of the additional information.
V primerih, ko država članica poročevalka zahteva dodatne informacije, se obdobje dvanajstih mesecev iz odstavka 1 za predložitev osnutka poročila o oceni podaljša za obdobje, ki ga odobri država članica poročevalka za predložitev dodatnih informacij.
If the requested information is submitted to the rapporteur Member State before the end of the period granted the extension shall correspond to the part of that period actually used.
Če se zahtevane informacije predložijo državi članici poročevalki pred iztekom odobrenega obdobja, podaljšanje ustreza delu navedenega obdobja, ki je že preteklo.
Where at the end of the period referred to in the first subparagraph of paragraph 3, the applicant has not submitted all of the additional information requested in accordance with paragraph 1, the rapporteur Member State shall inform the applicant, the Commission, the other Member States and the Authority and shall state the missing elements in the draft assessment report.
Če po izteku obdobja iz prvega pododstavka odstavka 3 vlagatelj ne predloži vseh dodatnih informacij, zahtevanih v skladu z odstavkom 1, država članica poročevalka o tem obvesti vlagatelja, Komisijo, druge države članice in Agencijo ter v osnutku poročila o oceni navede manjkajoče elemente.
If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit elements necessary for the assessment referred to in paragraph 1, it shall adopt a decision in accordance with Article 9(2)(b), providing that the active substance concerned is not to be included in Annex I to Directive 91/414/EEC.
Če Komisija potem, ko vlagatelju omogoči predložitev pripomb, ugotovi, da ta ni predložil manjkajočih elementov, potrebnih za oceno iz odstavka 1, sprejme v skladu s členom 9(2)(b) sklep o nevključitvi zadevne aktivne snovi v Prilogo I k Direktivi 91/414/EGS.
Circulation of and access to the draft assessment report
Posredovanje in dostop do osnutka poročila o oceni
The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant and the other Member States within 30 days from its receipt.
Agencija posreduje osnutek poročila o oceni, ki ga je prejela od države članice poročevalke, vlagatelju in drugim državam članicam najpozneje 30 dni po prejemu.
Where within this 30-day period the Authority does not receive the dossier provided for in Article 6(1) it shall circulate that report as soon as it receives that dossier.
Če Agencija v tem 30-dnevnem obdobju ne prejme dokumentacije iz člena 6(1), navedeno poročilo nemudoma po prejemu navedene dokumentacije posreduje naprej.
The period for the submission of written comments to the Authority from Member States and the applicant shall be 2 months.
Obdobje za predložitev pisnih pripomb držav članic in vlagatelja Agenciji je dva meseca.
The Authority shall make the draft assessment report available to the public, excluding any information in respect of which confidential treatment has been requested and justified by the applicant in accordance with Article 14 of Directive 91/414/EEC.
Agencija da osnutek poročila o oceni na voljo javnosti in izključi vse informacije, v zvezi s katerimi vlagatelj zahteva in utemeljuje zaupno obravnavanje v skladu s členom 14 Direktive 91/414/EGS.
It shall grant a period of 2 weeks to the applicant to request confidential treatment.
Agencija odobri vlagatelju dva tedna, v katerih lahko zahteva zaupno obravnavanje.
Within 4 months from the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion on whether the active substance can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public.
V štirih mesecih po izteku obdobja za predložitev pisnih pripomb Agencija sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnjevala pogoje iz člena 5 Direktive 91/414/EGS, in o tem obvesti vlagatelja, države članice in Komisijo ter da informacije na voljo javnosti.
Where appropriate, the Authority shall address in its conclusion the risk mitigation options in relation to the intended uses set out in the draft assessment report.
Agencija po potrebi v sklepu obravnava možnosti za zmanjšanje tveganja v zvezi z nameravanimi uporabami, določenimi v osnutku poročila o oceni.
The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State.
Agencija po potrebi organizira posvetovanje s strokovnjaki, vključno s strokovnjaki iz države članice poročevalke.
In that case the 4-month period for the adoption of the conclusion, as set out in paragraph 1, shall be extended by 2 months.
V takem primeru se obdobje štirih mesecev za sprejetje sklepa, kot je določeno v odstavku 1, podaljša za dva meseca.
Where the Authority needs additional information, it shall, in consultation with the rapporteur Member State, set a period of a maximum of 3 months for the applicant to submit that information to the Member States, the Commission and the Authority.
Če Agencija potrebuje dodatne informacije, določi v posvetovanju z državo članico poročevalko obdobje, ki ni daljše od treh mesecev, v katerem mora vlagatelj predložiti navedene informacije državam članicam, Komisiji in Agenciji.
It shall inform the applicant, the Commission and the Member States.
O tem obvesti vlagatelja, Komisijo in države članice.
In respect of applications for which a completeness decision was published by 31 December 2005, the maximum period shall be 5 months.
Za zahtevke, za katere je bil sklep o popolnosti objavljen do 31. decembra 2005, je najdaljše obdobje pet mesecev.
Within 2 months after receipt of the additional information the rapporteur Member State shall assess that information and submit an addendum to the draft assessment report to the Authority.
Država članica poročevalka v dveh mesecih po prejemu dodatnih informacij oceni navedene informacije in predloži dodatek k osnutku poročila Agenciji.
In respect of applications for which a completeness decision was published by 31 December 2005, that period shall be 3 months.
Za zahtevke, za katere je bil sklep o popolnosti objavljen do 31. decembra 2005, je navedeno obdobje treh mesecev.
Where the Authority requests additional information in accordance with paragraph 3, the period from the date of that request to the date of the submission of the addendum to the draft assessment report shall not be taken into account for the calculation of the period for the adoption of the conclusion, as provided for in paragraphs 1 and 2.
Če Agencija zahteva dodatne informacije v skladu z odstavkom 3, se obdobje od datuma navedene zahteve do datuma predložitve dodatka k osnutku poročila o oceni ne upošteva pri izračunu obdobja za sprejetje sklepa, kot je določeno v odstavkih 1 in 2.
In its conclusion the Authority shall only take into account additional information requested by it or by the rapporteur Member State and submitted within the period granted.
Agencija v svojem sklepu upošteva le dodatne informacije, ki jih zahteva sama ali država članica poročevalka, in so predložene v odobrenem obdobju.
The Authority shall establish the format for its conclusion which shall include details concerning the appraisal procedure and the properties of the active substance concerned.
Agencija določi obliko svojega sklepa, ki vključuje podatke o postopku pregleda in lastnostih zadevne aktivne snovi.
Presentation of a draft act
Predložitev osnutka akta
The Commission shall, at the latest 6 months after receipt of the conclusion of the Authority, submit to the Standing Committee on the Food Chain and Animal Health, hereinafter ‘the Committee’, a draft review report to be finalised at its meeting.
Komisija najpozneje šest mesecev po prejemu sklepa Agencije Stalnemu odboru za prehranjevalno verigo in zdravje živali (v nadaljnjem besedilu: Odbor) predloži osnutek poročila o pregledu, da se na njegovem sestanku pripravi končna različica.
The applicant shall be given the possibility to submit comments on the draft review report within a period, of up to 30 days, set by the Commission.
Vlagatelj ima možnost predložiti pripombe na osnutek poročila o pregledu v obdobju do 30 dni, ki ga določi Komisija.
On the basis of the draft review report and taking into account any comments submitted by the applicant within the period set by the Commission in accordance with paragraph 1, an act shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC, providing that:
Na podlagi osnutka poročila o pregledu in ob upoštevanju kakršnih koli pripomb, ki jih je vlagatelj predložil v obdobju, ki ga je Komisija določila v skladu z odstavkom 1, se sprejme akt v skladu s postopkom iz člena 19(2) Direktive 91/414/EGS, če:
The finalised review report, 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 available to the public.
Končna različica poročila o pregledu, razen delov, ki se nanašajo na zaupne informacije iz dokumentacije in so kot takšni določeni v skladu s členom 14 Direktive 91/414/EGS, se dajo na voljo javnosti.
Articles 2, 3 and Article 4(1) shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which the application was received by the rapporteur Member State by 17 March 2011 but for which no completeness check had been made by that date.
Členi 2, 3 in 4(1) se ne uporabljajo za vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, za katere je država članica poročevalka do 17. marca 2011 prejela zahtevek, vendar za katere do navedenega datuma ni bil opravljen pregled popolnosti.
For such applications the rapporteur Member State shall perform the completeness check provided for in Article 4(1) by 18 June 2011 at the latest.
Za takšne zahtevke država članica poročevalka opravi pregled popolnosti iz člena 4(1) najpozneje do 18. junija 2011.
Articles 2, 3 and 4 shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which the dossier was referred to the Committee in accordance with Article 6(2) of that Directive by 17 March 2011 but for which no completeness decision had been adopted by that date.
Členi 2, 3 in 4 se ne uporabljajo za vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, za katere je bila dokumentacija posredovana Odboru v skladu s členom 6(2) navedene direktive do 17. marca 2011, sklep o popolnosti pa zanje do navedenega datuma ni bil sprejet.
For such applications a completeness decision shall be adopted in accordance with Article 6(3) of Directive 91/414/EEC by 18 July 2011.
Za takšne zahtevke se sprejme sklep o popolnosti v skladu s členom 6(3) Direktive 91/414/EGS do 18. julija 2011.
Articles 2, 3 and 4 shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which a completeness decision was adopted but not published by 17 March 2011.
Členi 2, 3 in 4 se ne uporabljajo za zahtevke za vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, za katere je bil sklep o popolnosti sprejet, vendar ni bil objavljen do 17. marca 2011.
Articles 2 to 6 shall not apply to applications for inclusion of active substances in Annex I to Directive 91/414/EEC for which a completeness decision was published by 17 March 2011 but no draft assessment report had been submitted to the Commission by that date.
Členi 2 do 6 se ne uporabljajo za zahtevke za vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, za katere je bil sklep o popolnosti objavljen do 17. marca 2011, osnutek poročila o oceni pa Komisiji ni bil predložen do navedenega datuma.
Article 6(2) to (5) shall apply mutatis mutandis.
Člen 6(2) do (5) se uporablja smiselno.
Articles 2 to 6 and the first subparagraph of Article 7(1) shall not apply to applications for which the draft assessment report had been received by the Authority but not circulated to the applicant and the other Member States for comments by 17 March 2011.
Členi 2 do 6 in prvi pododstavek člena 7(1) se ne uporabljajo za zahtevke, za katere je Agencija prejela osnutek poročila o oceni, ki pa ni bil posredovan vlagatelju in drugim državam članicam za pripombe do 17. marca 2011.
By way of derogation from paragraph 5, for applications for which the draft assessment report had been submitted to the Commission and the Authority by 31 December 2009 at the latest, Articles 2 to 6 and the first subparagraph of Article 7(1) shall not apply.
Z odstopanjem od odstavka 5 se za zahtevke, za katere je bil osnutek poročila o oceni predložen Komisiji in Agenciji najpozneje do 31. decembra 2009, členi 2 do 6 in prvi pododstavek člena 7(1) ne uporabljajo.
In such cases, the following procedure shall apply.
V takšnih primerih se uporablja naslednji postopek:
By 18 April 2011, the rapporteur Member State shall request the applicant to inform that Member State and the Authority, within 1 month, in case the applicant considers that information that had not been submitted for the preparation of the draft assessment report and that might influence the outcome of the assessment, is available, specifying the nature of that information and its possible influence on the assessment.
Država članica poročevalka do 18. aprila 2011 zahteva, da vlagatelj obvesti navedeno državo članico in Agencijo v roku enega meseca, če vlagatelj meni, da so na voljo informacije, ki se niso predložile za pripravo osnutka poročila o oceni in ki bi lahko vplivale na rezultat ocene, z navedbo narave navedenih informacij in njihovim možnim vplivom na oceno.
Within 2 months from receiving the reply of the applicant, the Authority shall decide whether that information might influence the outcome of the assessment.
Agencija se v dveh mesecih od prejema odgovora vlagatelja odloči, ali bi navedene informacije lahko vplivale na rezultat ocene.
If so, the Authority shall, without undue delay, ask the rapporteur Member State to request the submission of that information by the applicant.
V takem primeru Agencija brez nepotrebnega odlašanja zaprosi državo članico poročevalko, da od vlagatelja zahteva predložitev navedenih informacij.
The rapporteur Member State shall update the draft assessment report where appropriate in the light of that information.
Država članica poročevalka glede na navedene informacije po potrebi posodobi osnutek poročila o oceni.
The Authority shall set a period of up to 6 months for the rapporteur Member State to prepare and submit to the Commission that updated draft assessment report, with a copy to the Authority.
Agencija določi obdobje do šestih mesecev, v katerem mora država članica poročevalka pripraviti in predložiti Komisiji navedeni posodobljeni osnutek poročila o oceni in kopijo predložiti Agenciji.
Article 6(2) to (5) shall apply mutatis mutandis, whereby the period referred to in the first subparagraph of Article 6(3) shall not exceed 3 months.
Člen 6(2) do (5) se uporablja smiselno, pri čemer obdobje iz prvega odstavka člen 6(3) ni daljše od treh mesecev.
The Commission shall set, and publish on its website, the dates for the circulation of the draft assessment reports referred to in paragraphs 5 and 6.
Komisija določi in objavi na svoji spletni strani datume za posredovanje osnutka poročila o oceni iz odstavkov 5 in 6.
Where a draft assessment report has been updated, as provided for in paragraph 6, it shall be circulated as updated.
Kadar je bil osnutek poročila o oceni posodobljen, kot je določeno v odstavku 6, se posreduje v posodobljeni obliki.
The Commission shall at the same time set, and publish on its website, the dates for the submission of comments thereon.
Komisija hkrati določi in objavi na svoji spletni strani datume za predložitev pripomb o tem.
correspond to the actual total cost of the work involved except if it is in public interest to lower the fees and charges.
skladne z dejanskimi skupnimi stroški opravljenega dela, razen če je zmanjšanje pristojbin in taks v javnem interesu.
Article 12 is without prejudice to Member States rights to maintain or introduce, in accordance with the Treaty, charges, levies or fees with regard to the authorisation, placing on the market, use and control of active substances and plant protection products other than the fee provided for in that Article.
Člen 12 ne posega v pravice držav članic, da v skladu s Pogodbo ohranijo ali uvedejo takse, dajatve ali pristojbine za registracijo, dajanje v promet, uporabo in nadzor aktivnih snovi ter fitofarmacevtskih sredstev, ki niso pristojbine iz navedenega člena.
For such applications the rapporteur Member State shall prepare and submit the draft assessment report to the Commission, with a copy to the Authority by 18 March 2012.
Za takšne zahtevke država članica poročevalka pripravi in predloži Komisiji osnutek poročila o oceni in pošlje kopijo Agenciji do 18. marca 2011.
Commission Regulation (EU) No 189/2011
Uredba Komisije (EU) št. 189/2011
It applies to the production and placing on the market of live animals and products of animal origin and, in certain specific cases, to exports thereof.
Uporablja se za proizvodnjo in dajanje na trg živih živali in proizvodov živalskega izvora ter, v nekaterih posebnih primerih, za njihov izvoz.
Chapter A of Annex VII to Regulation (EC) No 999/2001 lays down the eradication measures to be carried out following the confirmation of TSE in ovine and caprine animals.
Poglavje A Priloge VII k Uredbi (ES) št. 999/2001 določa ukrepe za izkoreninjenje, ki se izvajajo po potrditvi TSE pri ovcah in kozah.
In the case of confirmation of TSE other than bovine spongiform encephalopathy (BSE) in an ovine or caprine animal, the eradication measures consist in either the killing and complete destruction of all animals on the holding or the killing and complete destruction of ovine animals genetically susceptible to scrapie on the holding and in the killing and the complete destruction of all caprine animals on the holding insofar as no genetic resistance to scrapie has been demonstrated in caprine animals.
Ob potrditvi katere koli oblike TSE razen bovine spongiformne encefalopatije (BSE) pri ovcah in kozah ukrepi za izkoreninjenje bolezni vključujejo ali pokončanje in popolno uničenje vseh živali na kmetijskem gospodarstvu ali pokončanje in popolno uničenje ovc, ki so genetsko dovzetne za praskavec, na kmetijskem gospodarstvu ter pokončanje in popolno uničenje vseh koz na kmetijskem gospodarstvu, če genetska odpornost proti praskavcu pri kozah ni bila dokazana.
Chapter A of Annex VII to Regulation (EC) No 999/2001 also provides that the Member States may decide to delay the destruction of the animals by up to 5 breeding years subject to certain conditions.
Poglavje A Priloge VII k Uredbi (ES) št. 999/2001 določa tudi, da se lahko države članice pod določenimi pogoji odločijo za odložitev uničenja živali do pet rejnih let.
However, in the case of ovine or caprine animals kept for the production of milk with a view to placing it on the market, the killing and destruction of the animals may only be delayed for a maximum of 18 months.
Vendar se pokončanje in uničenje živali lahko odložita do največ 18 mesecev, kadar se ovce ali koze redijo za proizvodnjo mleka, ki se daje v promet.
Regulation (EC) No 999/2001 does not define the starting date for that deferred period of 18 months.
Uredba (ES) št. 999/2001 ne opredeljuje začetnega datuma za to obdobje odložitve 18 mesecev.
In the interests of certainty of Union legislation, it is appropriate to amend Annex VII to that Regulation so that the deferral period begins from the date of confirmation of the index case.
Zaradi večje pravne varnosti Unije je treba spremeniti Prilogo VII k navedeni uredbi, da se obdobje odložitve začne z datumom potrditve prvega registriranega primera.
In addition, in July 2010, the preliminary results of a scientific study [2] conducted by the Cypriot authorities under the supervision of the European Union Reference Laboratory (EURL) for TSEs showed that a genetic resistance to scrapie in caprine animals could exist.
Poleg tega so julija 2010 predhodni izsledki znanstvene študije [2], ki so jo izvedli ciprski organi pod nadzorom referenčnega laboratorija EU (EURL) za TSE, pokazali, da bi lahko pri kozah obstajala genetska odpornost proti praskavcu.
However, the definitive results of that study are not expected to be available before the second semester of 2012.
Vendar pa končni izsledki navedene študije verjetno ne bodo na voljo pred drugim polletjem leta 2012.
If that study confirms the existence of a resistance to scrapie, it may be considered appropriate, from January 2013, to amend Regulation (EC) No 999/2001, in order to exempt scrapie resistant caprine animals from the requirements for killing and complete destruction laid down in Chapter A of Annex VII to that Regulation.
Če navedena študija potrdi obstoj odpornosti proti praskavcu, je od januarja 2013 primerno spremeniti Uredbo (ES) št. 999/2001, da bi bile koze, odporne proti praskavcu, izvzete iz zahtev za pokončanje in popolno uničenje iz poglavja A Priloge VII k navedeni uredbi.
In order to avoid the unnecessary killing and complete destruction of caprine animals that may be considered as scrapie resistant in the near future, on holdings where animals are kept for the production of milk with a view to placing it on the market, it is appropriate to prolong the deferral period for the killing and complete destruction of those animals for a period ending on 31 December 2012, where the index case was confirmed before 1 July 2011.
Da bi se izognili nepotrebnemu pokončanju in popolnemu uničenju koz, ki se lahko štejejo kot odporne proti praskavcu v bližnji prihodnosti, je na kmetijskih gospodarstvih, kjer se živali redijo za proizvodnjo mleka, ki se daje v promet, primerno podaljšati obdobje odložitve za pokončanje in popolno uničenje navedenih živali za obdobje, ki se konča 31. decembra 2012, kadar bo prvi registrirani primer potrjen pred 1. julijem 2011.