natgillin/translations-raw huggingface dataset:
Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances [2] should continue to apply with respect to the renewal of the approval of the active substances listed in Annex I thereto.
Uredba Komisije (EU) št. 1141/2010 z dne 7. decembra 2010 o postopku za podaljšanje vključitve druge skupine aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in oblikovanju seznama navedenih snovi [2] bi se morala še naprej uporabljati glede podaljšanja odobritve aktivnih snovi, navedenih v Prilogi I k Uredbi.
Application for renewal
Vloga za podaljšanje odobritve
Submission of the application
Predložitev vloge
An application for the renewal of an approval of an active substance shall be submitted by a producer of the active substance to the rapporteur Member State, as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/2012 [3] and to the co-rapporteur Member State, as set out in the third column of that Annex, no later than three years before the expiry of the approval.When submitting an application, the applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request certain information to be kept confidential.
Vlogo za podaljšanje odobritve aktivne snovi predloži proizvajalec aktivne snovi najpozneje tri leta pred iztekom odobritve državi članici poročevalki iz drugega stolpca Priloge k Izvedbeni uredbi Komisije (EU) št. 686/2012 [3] in državi članici soporočevalki iz tretjega stolpca navedene priloge.Ob predložitvi vloge lahko vlagatelj v skladu s členom 63 Uredbe (ES) št. 1107/2009 zahteva, da se ohrani zaupnost nekaterih informacij.
In that event, the applicant shall present such parts of the application physically separated, setting out the reasons for requesting confidentiality.
V tem primeru vlagatelj te dele vloge predloži fizično ločeno in navede razloge za zahtevano zaupno obravnavanje.
At the same time, the applicant shall submit any data protection claims pursuant to Article 59 of Regulation (EC) No 1107/2009.
Vlagatelj hkrati predloži tudi kakršne koli zahtevke za varovanje podatkov v skladu s členom 59 Uredbe (ES) št. 1107/2009.
The applicant shall send a copy of the application to the Commission, the other Member States and to the European Food Safety Authority (‘the Authority’), including the information on those parts of the application in respect of which confidentiality has been requested as referred to in paragraph 1.
Vlagatelj pošlje kopijo vloge Komisiji, drugim državam članicam in Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija), vključno z informacijami o tistih delih vloge, v zvezi s katerimi je bilo zahtevano zaupno obravnavanje, kakor je navedeno v odstavku 1.
A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
Združenje proizvajalcev, ki ga imenujejo proizvajalci za zagotovitev skladnosti s to uredbo, lahko predloži skupno vlogo.
Format and contents of the application
Oblika in vsebina vloge
The application shall be submitted in the format set out in the Annex.
Vloga se predloži v obliki, ki je določena v Prilogi.
The application shall list the new information the applicant intends to submit.
Vlagatelj v vlogi navede nove informacije, ki jih namerava predložiti.
It shall demonstrate that such information is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009.
V njej dokaže, da so take informacije nujne v skladu s prvim pododstavkom člena 15(2) Uredbe (ES) št. 1107/2009.
The application shall list separately any new studies involving vertebrate animals that the applicant intends to submit.
V vlogi se ločeno navedejo kakršne koli nove študije, ki jih vlagatelj namerava predložiti in ki vključujejo vretenčarje.
Checking of the application
Preverjanje vloge
Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the application and the fact that it has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2.
Če je bila vloga predložena do datuma, določenega v prvem pododstavku člena 1(1), in vsebuje vse elemente iz člena 2, država članica poročevalka v enem mesecu od datuma prejema zahtevka obvesti vlagatelja, državo članico soporočevalko, Komisijo in Agencijo o datumu prejema vloge in o tem, da je bila predložena do datuma iz prvega pododstavka člena 1(1) in vsebuje vse elemente iz člena 2.
The rapporteur Member State shall assess any request for confidentiality.
Država članica poročevalka oceni zahtevek za zaupno obravnavanje.
Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) but one or more elements provided for in Article 2 are missing, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the Rapporteur Member State and to the co-rapporteur Member State.
Če je bila vloga predložena do datuma, določenega v prvem pododstavku člena 1(1), vendar ne vsebuje enega ali več elementov iz člena 2, država članica poročevalka v enem mesecu od datuma prejema vloge obvesti vlagatelja, kateri elementi manjkajo, in določi rok 14 dni za predložitev navedenih elementov državi članici poročevalki in državi članici soporočevalki.
Where the application contains all the elements provided for in Article 2 at the expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.
Če vloga ob izteku navedenega roka vsebuje vse elemente iz člena 2, država članica poročevalka nemudoma nadaljuje postopek v skladu z odstavkom 1.
Where the application has not been submitted by the date provided for in the first subparagraph of Article 1(1), or where the application still does not contain all the elements provided for in Article 2 at the expiry of the period set for the submission of the missing elements in accordance with paragraph 2, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application is inadmissible and of the reasons why it is inadmissible.
Če vloga ni bila predložena do datuma iz prvega pododstavka člena 1(1) ali če ob izteku roka, določenega za predložitev manjkajočih elementov v skladu z odstavkom 2, še vedno ne vsebuje vseh elementov iz člena 2, država članica poročevalka nemudoma obvesti vlagatelja, državo članico soporočevalko, Komisijo, druge države članice in Agencijo, da je vloga nedopustna, in navede razloge, zakaj je nedopustna.
Within 14 days from the date of receipt of the information that the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit to the Authority a copy of the application, including the information about those parts of the application in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
V 14 dneh od datuma prejema obvestila, da je bila vloga predložena do datuma iz prvega pododstavka člena 1(1) in da vsebuje vse elemente iz člena 2, vlagatelj predloži Agenciji kopijo vloge, vključno z informacijami o tistih delih vloge, v zvezi s katerimi je zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009.
At the same time, the applicant shall forward a copy of the application to the Authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
Vlagatelj hkrati posreduje kopijo vloge Agenciji in izključi vse informacije, v zvezi s katerimi je zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009.
Where, by the date provided for in the first subparagraph of Article 1(1), two or more applications for the same active substance have been submitted separately and each of them contains all the elements provided for in Article 2, the rapporteur Member State shall communicate the contact details of each applicant to the other applicant(s).
Če sta za isto aktivno snov do datuma iz prvega pododstavka člena 1(1) ločeno predloženi dve vlogi ali več in vsaka od teh vlog vsebuje vse elemente iz člena 2, država članica poročevalka sporoči kontaktne podatke vsakega vlagatelja drugim vlagateljem.
The Commission shall publish, for each active substance, the names and the addresses of the applicants whose applications have been submitted by the date provided for in the first subparagraph of Article 1(1) and contain all the elements provided for in Article 2.
Komisija za vsako aktivno snov objavi imena in naslove vlagateljev, ki so vloge predložili do datuma iz prvega pododstavka člena 1(1) in vsebujejo vse elemente iz člena 2.
Contacts prior to submission of supplementary dossiers
Stiki pred predložitvijo dopolnilne dokumentacije
The applicant may request a meeting with the rapporteur Member State and the co-rapporteur Member State to discuss the application.
Vlagatelj lahko zahteva sestanek z državo članico poročevalko in državo članico soporočevalko za obravnavanje vloge.
If requested, such pre-submission contacts shall take place prior to the submission of supplementary dossiers, as provided for in Article 6.
Če se zahtevajo, mora do takih stikov priti pred predložitvijo dopolnilne dokumentacije iz člena 6.
Access to the application
Dostop do vloge
Upon receipt of the application, as provided for in Article 3(4), the Authority shall make it available to the public without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Agencija po prejemu vloge, določene v členu 3(4), javnosti nemudoma zagotovi dostop do vloge, izključi pa vse informacije, v zvezi s katerimi je vlagatelj zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009, razen če prevlada javni interes za razkritje.
Supplementary dossiers
Dopolnilna dokumentacija
Where the rapporteur Member State has informed the applicant in accordance with Article 3(1) that its application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the Authority.
Če je država članica poročevalka vlagatelja v skladu s členom 3(1) obvestila, da je bila njegova vloga predložena do datuma iz prvega pododstavka člena 1(1) in da vsebuje vse elemente iz člena 2, vlagatelj predloži dopolnilno dokumentacijo državi članici poročevalki, državi članici soporočevalki, Komisiji in Agenciji.
The contents of the supplementary summary dossier and the supplementary complete dossier shall comply with Article 7.
Vsebina povzetka dopolnilne dokumentacije in popolna dopolnilna dokumentacija mora biti skladna s členom 7.
The supplementary dossiers shall be submitted no later than 30 months before the expiry of the approval.
Dopolnilna dokumentacija se predloži najpozneje 30 mesecev pred iztekom odobritve.
Where there is more than one applicant requesting renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly.
Če je podaljšanje odobritve iste aktivne snovi zahtevalo več vlagateljev, navedeni vlagatelji sprejmejo vse ustrezne ukrepe, da dokumentacijo predložijo skupaj.
Where such dossiers are not submitted jointly by all the applicants concerned, the reasons shall be set out in the dossiers.
Če vsi zadevni vlagatelji take dokumentacije ne predložijo skupaj, je treba v dokumentaciji navesti razloge za to.
When submitting the supplementary dossiers, the applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
Ob predložitvi dopolnilne dokumentacije lahko vlagatelj v skladu s členom 63 Uredbe (ES) št. 1107/2009 zaprosi, da nekatere informacije in nekateri deli dokumentacije ostanejo zaupni, in take informacije fizično loči.
where the applicant is joined or replaced by one or more other applicants, the name and address of that applicant or those other applicants and, if applicable, the name of the association of producers provided for in Article 1(3);
če je vlagatelj združen ali nadomeščen z drugim vlagateljem ali drugimi vlagatelji, ime in naslov navedenega vlagatelja ali navedenih vlagateljev in, če je primerno, ime združenja proizvajalcev iz člena 1(3);
information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are fulfilled; where the information submitted does not cover all zones or does not concern a widely grown crop, a justification shall be submitted;
informacije v zvezi z eno ali več reprezentativnimi uporabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje aktivno snov, na splošno razširjenem posevku v vsaki coni, ki dokazujejo, da so izpolnjena merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009; če predložene informacije ne zajemajo vseh con ali splošno razširjenega posevka, je treba predložiti utemeljitev;
data and risk assessments which were not part of the approval dossier or subsequent renewal dossiers and which are necessary:
podatke in ocene tveganj, ki niso del dokumentacije za odobritev ali naknadnih dokumentacij za podaljšanje odobritve in so nujni:
to reflect changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned;
da se upoštevajo spremembe pravnih zahtev, ki so se pojavile od odobritve ali zadnjega podaljšanja odobritve zadevne aktivne snovi;
to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;
da se upoštevajo spremembe na področju znanstvenega in tehničnega znanja, ki so se pojavile od odobritve ali zadnjega podaljšanja odobritve zadevne aktivne snovi;
to reflect changes to representative uses; or
da se upoštevajo spremembe reprezentativnih uporab ali
because the application is for an amended renewal;
ker je vloga za podaljšanje spremenjene odobritve;
for each point of the data requirements for the active substance, as set out in a Regulation setting out data requirements for active substances under Regulation (EC) No 1107/2009, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried them out and the reason why each test or study is necessary;
za vsako točko zahtev po podatkih o aktivni snovi, določenih v uredbi o določitvi zahtev po podatkih za aktivne snovi v skladu z Uredbo (ES) št. 1107/2009, za katero so potrebni novi podatki v skladu s točko (d), povzetke ter rezultate preskusov in študij, ime njihovega lastnika in osebe ali ustanove, ki so jih izvajale, in razloge, zakaj je vsak posamezni preskus ali študija nujen;
for each point of the data requirements for the plant protection product, as set out in a Regulation setting out data requirements for plant protection products under Regulation (EC) No 1107/2009, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies, for one or more plant protection products which are representative of the supported uses, and the reason why each test or study is necessary;
za vsako točko zahtev po podatkih o fitofarmacevtskem sredstvu, določenih v uredbi o določitvi zahtev po podatkih za fitofarmacevtska sredstva v skladu z Uredbo (ES) št. 1107/2009, za katero so potrebni novi podatki v skladu s točko (d), povzetke ter rezultate preskusov in študij, ime njihovega lastnika in osebe ali ustanove, ki so jih izvajale, za eno ali več fitofarmacevtskih sredstev, ki so reprezentativna za predvideno uporabo, in razloge, zakaj je vsak posamezni preskus ali študija nujen;
where relevant, documented evidence as referred to in Article 4(7) of Regulation (EC) No 1107/2009;
dokumentirane dokaze iz člena 4(7) Uredbe (ES) št. 1107/2009, kadar je to ustrezno;
for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals;
za vsak preskus ali študijo, ki vključuje vretenčarje, opis ukrepov, sprejetih za preprečitev testiranja na vretenčarjih;
where relevant, a copy of an application for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council [4];
kopijo vloge za mejne vrednosti ostankov iz člena 7 Uredbe Evropskega parlamenta in Sveta (ES) št. 396/2005 [4], kadar je to ustrezno;
where relevant, a copy of the proposal for classification where it is considered that the substance has to be classified or reclassified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council [5];
kopijo predloga za razvrstitev, če se šteje, da je treba snov razvrstiti ali ponovno razvrstiti v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta [5], kadar je to ustrezno;
a checklist demonstrating that the supplementary dossier provided for in paragraph 3 is complete in view of the uses applied for and indicating which data are new;
kontrolni seznam, ki dokazuje, da je dopolnilna dokumentacija iz odstavka 3 popolna glede na uporabo, na katero se nanaša zahtevek, z navedbo, kateri podatki so novi;
the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009.
povzetke in rezultate strokovno pregledane javno dostopne znanstvene literature iz člena 8(5) Uredbe (ES) št. 1107/2009.
The uses referred to in paragraph 1(c) shall, where appropriate, include the uses evaluated for the approval or subsequent renewals.
Uporabe iz odstavka 1(c) po potrebi vključujejo ocenjene uporabe za odobritev ali naknadna podaljšanja odobritve.
At least one plant protection product referred to in paragraph 1(c) shall contain no other active substance, where such a product exists for a representative use.
Vsaj eno fitofarmacevtsko sredstvo iz odstavka 1(c) ne vsebuje nobene druge aktivne snovi, kadar obstaja tako sredstvo za reprezentativno uporabo.
The supplementary complete dossier shall contain the full text of each test and study report referred to in paragraph 1(e), (f) and (m).
Popolna dopolnilna dokumentacija vsebuje celotno besedilo poročila o vsakem preskusu in študiji iz odstavka 1(e), (f) in (m).
It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product containing it to humans.
Ne vključuje poročil o preskusih ali študijah, ki vključujejo namerno uporabo aktivne snovi ali fitofarmacevtskega sredstva, ki jo vsebuje, pri človeku.
Admissibility of the application
Dopustnost vloge
Where the supplementary dossiers have been submitted by the date provided for in Article 6(3) and contain all the elements provided for in Article 7, the rapporteur Member State shall, within a period of one month, inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the supplementary dossiers and of the admissibility of the application.
Če je bila dopolnilna dokumentacija predložena do datuma iz člena 6(3) in vsebuje vse elemente iz člena 7, država članica poročevalka v enem mesecu obvesti vlagatelja, državo članico soporočevalko, Komisijo in Agencijo o datumu prejema dopolnilne dokumentacije in dopustnosti vloge.
The rapporteur Member State shall assess any requests for confidentiality.
Država članica poročevalka oceni zahtevke za zaupno obravnavanje.
In the event of a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
V primeru zahteve za dostop do informacij se država članica poročevalka odloči, katere informacije bodo ostale zaupne.
Where the supplementary dossiers have been submitted by the date provided for in Article 6(3), but one or more elements provided for in Article 7 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the supplementary dossiers, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the rapporteur Member State and co-rapporteur Member State.
Če je bila dopolnilna dokumentacija predložena do datuma iz člena 6(3), vendar ne vsebuje enega ali več elementov iz člena 7, država članica poročevalka v enem mesecu od datuma prejema dopolnilne dokumentacije obvesti vlagatelja, kateri elementi manjkajo, in določi rok 14 dni za predložitev navedenih elementov državi članici poročevalki in državi članici soporočevalki.
Where at the expiry of that period the supplementary dossiers contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.
Če dopolnilna dokumentacija ob izteku navedenega roka vsebuje vse elemente iz člena 7, država članica poročevalka nemudoma nadaljuje postopek v skladu z odstavkom 1.
After receiving the information that the application is admissible, the applicant shall immediately forward the supplementary dossiers to the other Member States, the Commission and the Authority, including the information about those parts of the dossier in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
Po prejemu obvestila, da je vloga dopustna, vlagatelj nemudoma posreduje dopolnilno dokumentacijo drugim državam članicam, Komisiji in Agenciji, vključno z informacijami o tistih delih dokumentacije, v zvezi s katerimi je vlagatelj zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009.
At the same time, the applicant shall forward the supplementary summary dossiers to the Authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
Vlagatelj hkrati posreduje povzetek dopolnilne dokumentacije Agenciji in izključi vse informacije, v zvezi s katerimi je zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009.
The Authority shall make the supplementary summary dossier available to the public, without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Agencija javnosti nemudoma zagotovi dostop do povzetka dopolnilne dokumentacije, izključi pa vse informacije, za katere je vlagatelj zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009, razen če prevlada javni interes za razkritje.