natgillin/translations-raw huggingface dataset:
It shall also check the requests for confidentiality referred to in Article 7(3) and the complete lists of tests and studies submitted pursuant to Article 8(2).
Preveri tudi zahtevke glede zaupnosti podatkov iz člena 7(3) in popoln seznam predloženih preskusov in študij v skladu s členom 8(2).
Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the other Member States and the Commission that the application is inadmissible.
Če ob koncu tega obdobja vlagatelj ne predloži manjkajočih podatkov, država članica poročevalka obvesti vlagatelja, Komisijo in druge države članice, da zahtevek ni dopusten.
Where the dossiers submitted with the application contain all the elements provided for in Article 8, the rapporteur Member State shall notify the applicant, the other Member States, the Commission and the Authority of the admissibility of the application and start assessing the active substance.
Če dokumentacija, predložena skupaj z zahtevkom, vključuje vse elemente iz člena 8, država članica poročevalka vlagatelja, Komisijo, druge države članice in Agencijo obvesti o dopustnosti zahtevka in začne ocenjevanje aktivne snovi.
After receiving that notification, the applicant shall immediately forward the dossiers as provided for in Article 8 to the other Member States, the Commission and the Authority, including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 7(3).
Po prejemu tega obvestila vlagatelj nemudoma posreduje dokumentacijo, kakor je določena v členu 8, drugim državam članicam, Agenciji in Komisiji, vključno z informacijami glede delov dokumentacije, v zvezi s katerimi je bila zahtevana zaupnost, kakor to izhaja iz člena 7(3).
Access to the summary dossier
Dostop do povzetka dokumentacije
The Authority shall without delay make the summary dossier referred to in Article 8(1) available to the public, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure.
Agencija povzetek dokumentacije iz člena 8(1) nemudoma da na voljo javnosti, in izključi vse informacije, v zvezi s katerimi se zahteva in je upravičeno zaupno obravnavanje v skladu s členom 63, razen če prevlada javni interes za razkritje.
Draft assessment report
Osnutek poročila o oceni
Within 12 months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report, referred to as the ‘draft assessment report’, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.
V dvanajstih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Komisiji – v vednost Agenciji – predloži poročilo, (v nadaljnjem besedilu: osnutek poročila o oceni), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila merila za odobritev iz člena 4.
The draft assessment report shall also include where relevant, a proposal to set maximum residue levels.
Osnutek poročila o oceni, kjer je to ustrezno, vključuje tudi predlog za določitev mejne vrednosti ostankov.
The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.
Država članica poročevalka opravi neodvisno, objektivno in pregledno oceno glede na trenutna znanstvena in tehnična spoznanja.
Where, pursuant to Article 4(1), the assessment establishes that the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are not satisfied, the draft assessment report shall be limited to those parts of the assessment.
Če se v skladu s členom 4(1) v okviru ocene ugotovi, da merila za odobritev iz točk 3.6.2 do 3.6.4 in 3.7 Priloge II niso izpolnjena, je osnutek poročila o oceni omejen na te dele ocene.
Where the rapporteur Member State needs additional studies or information, it shall set a period in which the applicant must supply those studies or that information.
Če država članica poročevalka potrebuje dodatne študije, določi rok, v katerem mora vlagatelj predložiti navedene študije ali informacije.
In that case, the 12-month period shall be extended by the additional period granted by the rapporteur Member State.
V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica poročevalka.
The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the rapporteur Member State.
Dodatno obdobje ni daljše od šestih mesecev in preneha, ko država članica poročevalka prejme dodatne informacije.
It shall inform the Commission and the Authority accordingly.
O tem ustrezno obvesti Komisijo in Agencijo.
Where at the end of the additional period, the applicant has not submitted the additional studies or information, the rapporteur Member State shall inform the applicant, the Commission and the Authority and shall state the missing elements in the assessment included in the draft assessment report.
Če ob koncu dodatnega obdobja vlagatelj ne predloži dodatnih študij ali informacij, država članica poročevalka obvesti vlagatelja, Komisijo in Agencijo ter manjkajoče elemente navede v oceni, vključeni v osnutek poročila o oceni.
The format of the draft assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).
Oblika osnutka poročila o oceni se določi v skladu s svetovalnim postopkom iz člena 79(2).
The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant and the other Member States at the latest 30 days after its receipt.
Agencija razpošlje osnutek poročila o oceni, ki ga je prejela od države članice poročevalke, vlagateljem in ostalim državam članicam najpozneje 30 dni po prejemu.
It shall ask the applicant to circulate an update of the dossier where applicable to the Member States, the Commission and the Authority.
Od vlagatelja zahteva, da Agenciji, Komisiji in državam članicam, kjer je to primerno, razpošlje posodobljeno dokumentacijo.
The Authority shall make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63, that certain parts of the draft assessment report be kept confidential.
Agencija da osnutek poročila o oceni na voljo javnosti, vendar pa vlagatelju omogoči rok dveh tednov, v katerih lahko v skladu s členom 63 zahteva, da nekateri deli osnutka poročila o oceni ostanejo zaupni.
The Authority shall allow a period of 60 days for the submission of written comments.
Agencija dovoli obdobje 60 dni za predložitev pisnih pripomb.
The Authority, where appropriate shall 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.
Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public.
Agencija v 120 dneh od konca obdobja za predložitev pisnih pripomb, glede na trenutna znanstvena in tehnična spoznanja, ob uporabi smernic, ki so na voljo v času predložitve vloge, sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila merila za odobritev iz člena 4, in o tem obvesti vlagatelja, države članice in Komisijo ter sklep da na voljo javnosti.
In the event of a consultation as provided for in this paragraph, the 120-day period shall be extended by 30 days.
Če se organizira posvetovanje iz prvega pododstavka, se 120-dnevno obdobje podaljša za 30 dni.
Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.
Agencija po potrebi v sklepih obravnava možnosti za zmanjševanje tveganja, določene v osnutku poročila o oceni.
Where the Authority needs additional information, it shall set a period of a maximum of 90 days for the applicant to supply it to the Member States, the Commission and the Authority.
Če Agencija potrebuje dodatne informacije, določi rok, ki ni daljši od 90 dni, v katerem mora vlagatelj te informacije predložiti državam članicam, Komisiji in Agenciji.
The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after receipt of the additional information.
Država članica poročevalka oceni dodatne informacije ter jih takoj in najpozneje v 60 dneh po prejemu dodatnih informacij predloži Agenciji.
In that case the 120-day period provided for in paragraph 2 shall be extended by a period which shall cease at the moment when the additional assessment is received by the Authority.
V tem primeru se obdobje 120 dni iz odstavka 2 podaljša za obdobje, ki preneha, ko Agencija prejme dodatno oceno.
The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements in Article 29(1)(g) of this Regulation.
Agencija lahko Komisijo zaprosi, da se posvetuje z referenčnim laboratorijem Skupnosti, ustanovljenim v skladu z Uredbo (ES) št. 882/2004, zaradi preverjanja, ali je analitska metoda za določitev ostankov, ki jo predlaga vlagatelj, ustrezna in izpolnjuje zahteve iz člena 29(1)(g) te uredbe.
The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.
Vlagatelj na zahtevo referenčnega laboratorija Skupnosti predloži vzorce in analitske standarde.
The conclusion of the Authority shall include details concerning the evaluation procedure and the properties of the active substance concerned.
Sklep Agencije vključuje podatke o postopku ocenjevanja in lastnostih zadevne aktivne snovi.
The Authority shall establish the format for its conclusion which shall include details concerning the evaluation procedure and the properties of the active substance concerned.
Agencija določi obliko svojega sklepa, ki bo vključeval podatke o postopku ocenjevanja in lastnostih zadevne aktivne snovi.
The time limits for the Authority’s opinion on applications concerning maximum residue levels set out in Article 11 and for decisions on applications concerning maximum residue levels set out in Article 14 of Regulation (EC) No 396/2005 shall be without prejudice to the time limits laid down in this Regulation.
Roki za mnenje Agencije o vlogah glede mejnih vrednosti ostankov iz člena 11 in odločitve o vlogah glede mejnih vrednosti ostankov iz člena 14 Uredbe (ES) št. 396/2005 ne posegajo v roke, določene v tej uredbi.
Where the conclusion of the Authority is adopted within the time limit set out in paragraph 2 of this Article, extended by any additional period set in accordance with paragraph 3, the provisions of Article 11 of Regulation (EC) No 396/2005 shall not apply and the provisions of Article 14 of that Regulation shall apply without delay.
Če Agencija sprejme sklep v roku, določenem v odstavku 2 tega člena in podaljšanem za dodatno obdobje, določeno v odstavku 3, se določbe člena 11 Uredbe (ES) št. 396/2005 ne uporabljajo in se nemudoma začnejo uporabljati določbe člena 14 navedene uredbe.
Where the conclusion of the Authority is not adopted within the time limit set out in paragraph 2 of this Article, extended by any additional period set in accordance with paragraph 3, the provisions of Articles 11 and 14 of Regulation (EC) No 396/2005 shall apply without delay.
Če Agencija sklepov ne sprejme v roku, določenem v odstavku 2 tega člena in podaljšanem za dodatno obdobje, določeno v odstavku 3, se nemudoma začnejo uporabljati določbe členov 11 in 14 Uredbe (ES) št. 396/2005.
Approval Regulation
Uredba o odobritvi
Within six months of receiving the conclusion from the Authority, the Commission shall present a report, referred to as ‘the review report’, and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the rapporteur Member State and the conclusion of the Authority.
V šestih mesecih po prejemu sklepa Agencije Komisija Odboru iz člena 79(1) predloži poročilo, (v nadaljnjem besedilu: poročilo o pregledu), in osnutek uredbe, ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka, in sklepa Agencije.
The applicant shall be given the possibility to submit comments on the review report.
Vlagatelj ima možnost, da predloži pripombe na poročilo o pregledu.
On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
Na podlagi poročila o pregledu, drugih dejavnikov, povezanih z obravnavano zadevo, in previdnostnega načela, kadar so pogoji iz člena 7(1) Uredbe (ES) št. 178/2002 relevantni, se uredba sprejme v skladu z regulativnim postopkom iz člena 79(3), če:
an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;
je aktivna snov odobrena pod pogoji in omejitvami iz člena 6, kjer je to primerno;
an active substance is not approved; or
aktivna snov ni odobrena; ali
the conditions of the approval are amended.
se pogoji za odobritev spremenijo.
Where the approval provides for the submission of further confirmatory information as referred to in Article 6(f), the Regulation shall provide the time limit to submit the information to the Member States, the Commission and the Authority.
Če odobritev zajema predložitev dodatnih podatkov potrditvene narave iz člena 6(f), se v uredbi določi rok za predložitev podatkov državam članicam, Agenciji in Komisiji.
The rapporteur Member State shall assess the additional information and submit its assessment to the other Member States, the Commission and the Authority without delay and at the latest six months after the receipt of the additional information.
Država članica poročevalka oceni dodatne informacije ter oceno takoj in najpozneje šest mesecev po prejemu dodatnih informacij predloži drugim državam članicam, Komisiji in Agenciji.
Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved.
Odobrene aktivne snovi se vključijo v uredbo iz člena 78(3), ki vsebuje seznam že odobrenih aktivnih snovi.
The Commission shall maintain a list of approved active substances electronically available to the public.
Komisija vodi seznam odobrenih aktivnih snovi, ki je javnosti na voljo v elektronski obliki.
Renewal and review
Obnovitev in pregled
Renewal of approval
Obnovitev odobritve
On application the approval of an active substance shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied.
Na podlagi zahtevka se odobritev aktivne snovi obnovi, kadar se ugotovi, da so izpolnjena merila za odobritev iz člena 4.
Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.
Merila iz člena 4 se štejejo za izpolnjena, kadar je bilo to ugotovljeno v zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje to aktivno snov.
Such renewal of the approval may include conditions and restrictions, as referred to in Article 6.
Takšna obnovitev odobritve lahko vključuje pogoje in omejitve iz člena 6.
The renewal of the approval shall be for a period not exceeding 15 years.
Obnovitev odobritve velja največ petnajst let.
The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years.
Odobritev aktivne snovi iz člena 4(7) se lahko obnovi za obdobje največ petih let.
Application for renewal
Zahtevek za obnovitev
The application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the approval.
Zahtevek iz člena 14 proizvajalec aktivne snovi predloži državi članici, pri čemer pošlje po en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom odobritve.
When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his request is for an amended approval.
V zahtevku za obnovitev vlagatelj navede nove podatke, ki jih namerava predložiti, in dokaže, da so nujni zaradi zahtev po podatkih ali merilih, ki se pri zadnji odobritvi aktivne snovi niso uporabljala, ali ker njegov zahtevek zadeva spremembo odobritve.
The applicant shall at the same time submit a timetable of any new and ongoing studies.
Vlagatelj hkrati predloži časovni razpored novih in še trajajočih študij.
The applicant shall identify, giving reasons, the parts of the information submitted that he requests to be kept confidential in accordance with Article 63 and at the same time any data protection claims pursuant to Article 59.
Vlagatelj opredeli za katere dele predloženih informacij zahteva, da v skladu s členom 63 ostanejo zaupni in to utemelji, ter hkrati vse zahteve v zvezi z varstvom podatkov v skladu s členom 59.
The Authority shall, without delay, make available to the public the information provided by the applicant under Article 15, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure.
Agencija da informacije, ki jih predloži vlagatelj v skladu s členom 15, nemudoma na voljo javnosti, in izključi vse informacije, v zvezi s katerimi se zahteva in je upravičeno zaupno obravnavanje v skladu s členom 63, razen če prevlada javni interes za razkritje.
Extension of approval period for the duration of the procedure
Podaljšanje obdobja odobritve za čas trajanja postopka
Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.
Kadar zaradi razlogov, na katere vlagatelj ne more vplivati, obstaja možnost, da bo odobritev potekla pred sprejetjem sklepa o obnovitvi, se sklep sprejme v skladu z regulativnim postopkom iz člena 79(3) in prenehanje odobritve za tega vlagatelja se odloži za obdobje, ki zadošča za preučitev vloge.
A Regulation postponing the expiry for a period sufficient to examine the application shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(5) where an applicant could not give the three years’ notice required under Article 15(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired before 14 June 2014.
Uredba o odložitvi prenehanja obdobja, ki zadošča za preučitev vloge, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 79(5), kadar vlagatelji niso mogli upoštevati triletnega obdobja iz člena 15(1), ker je bila aktivna snov vključena v Prilogo I k Direktivi 91/414/EGS za obdobje, ki se je izteklo pred 14. junijem 2014.
The length of that period shall be established on the basis of the following:
Dolžina teh obdobij se določi na podlagi:
the time needed to provide the information requested;
časa, potrebnega za predložitev zahtevanih informacij;
the time needed to complete the procedure;
časa, potrebnega za zaključitev postopka;
where appropriate, the need to ensure the establishment of a coherent work programme, as provided for in Article 18.
kjer je primerno, potrebe po zagotovitvi oblikovanja skladnega delovnega programa, kakor je določen v členu 18.
The Commission may establish a work programme grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment and taking into account, as far as possible, the need for an effective control and resistance management of target pest.
Komisija lahko oblikuje delovni program, ki združuje podobne aktivne snovi ter določi prednostne naloge na podlagi skrbi za varovanje zdravja ljudi in živali ali okolja ter pri tem kolikor je mogoče upošteva potrebo po učinkovitem varstvu rastlin in obvladovanju odpornosti ciljnih škodljivih organizmov.
The programme may require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a period provided for in the programme.
Ta program lahko od zainteresiranih strani zahteva, da državam članicam, Komisiji in Agenciji v roku, ki ga določa program, predložijo vse potrebne podatke.
The programme shall include the following:
Program vsebuje:
the procedures concerning the submission and assessment of applications for renewal of approvals;
postopke v zvezi s predložitvijo in ocenjevanjem vlog za obnovitev odobritev;
the necessary data to be submitted, including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies;
potrebne podatke, ki jih je treba predložiti, vključno z ukrepi za omejitev poskusov na živalih, zlasti z uporabo metod, pri katerih se ne uporabljajo živali, in inteligentnih strategij preskušanja;
the periods for submission of such data;
časovne roke za predložitev takšnih podatkov;
rules on the submission of new information;
pravila o predložitvi novih informacij;
period for assessment and decision making;
obdobje za izvedbo ocene in odločanje;
the allocation of evaluation of active substances to Member States, taking into account a balance in the responsibilities and work to be done among Member States acting as rapporteurs.
razporeditev ocene aktivnih snovi državam članicam, ob upoštevanju ravnovesja med odgovornostjo in zahtevanim obsegom dela med državami članicami poročevalkami.
A Regulation, adopted in accordance with the regulatory procedure referred to in Article 79(3), shall set out the provisions necessary for the implementation of the renewal procedure, including, where relevant, the implementation of a work programme, as provided for in Article 18.
Uredba, sprejeta v skladu z regulativnim postopkom iz člena 79(3), opredeljuje določbe, potrebne za izvedbo postopka podaljšanja, vključno z izvedbo delovnega programa iz člena 18, kadar je to primerno.
Renewal Regulation
Uredba o obnovitvi
A Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
Uredba se sprejme v skladu z regulativnim postopkom iz člena 79(3), če:
the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or
se odobritev aktivne snovi obnovi, kadar je to primerno, pod pogoji in omejitvami; ali
the approval of an active substance is not renewed.
se odobritev aktivne snovi ne obnovi.