natgillin/translations-raw huggingface dataset:
It is therefore appropriate not to renew the approval of quinoxyfen in accordance with Article 20(1)(b) of that Regulation.
Zato je v skladu s členom 20(1)(b) navedene uredbe primerno, da se odobritev kvinoksifena ne obnovi.
Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing quinoxyfen.
Državam članicam bi bilo treba zagotoviti dovolj časa za preklic registracij fitofarmacevtskih sredstev, ki vsebujejo kvinoksifen.
For plant protection products containing quinoxyfen, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 27 March 2020.
Za fitofarmacevtska sredstva, ki vsebujejo kvinoksifen in pri katerih države članice odobrijo morebitno prehodno obdobje v skladu s členom 46 Uredbe (ES) št. 1107/2009, bi se moralo navedeno obdobje izteči najpozneje 27. marca 2020.
Commission Implementing Regulation (EU) 2018/524 extended the expiry date of quinoxyfen to 30 April 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance.
Z Izvedbeno uredbo Komisije (EU) 2018/524 je bil datum veljavnosti odobritve kvinoksifena podaljšan do 30. aprila 2019, da bi se omogočil zaključek postopka obnovitve pred prenehanjem odobritve navedene snovi.
Given that a decision has been taken ahead of this extended expiry date, this Regulation should apply as soon as possible.
Glede na to, da je bil sklep sprejet pred tem podaljšanim datumom veljavnosti odobritve, bi se morala ta uredba začeti uporabljati čim prej.
This Regulation does not prevent the submission of a further application for the approval of quinoxyfen pursuant to Article 7 of Regulation (EC) No 1107/2009.
Ta uredba ne vpliva na predložitev ponovnega zahtevka za odobritev kvinoksifena v skladu s členom 7 Uredbe (ES) št. 1107/2009.
The approval of the active substance quinoxyfen is not renewed.
Odobritev aktivne snovi kvinoksifen se ne obnovi.
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 82, on quinoxyfen, is deleted.
V delu A Priloge k Izvedbeni uredbi (EU) št. 540/2011 se vrstica 82 za kvinoksifen črta.
Member States shall withdraw authorisations for plant protection products containing quinoxyfen as active substance by 27 June 2019 at the latest.
Države članice prekličejo registracije fitofarmacevtskih sredstev, ki vsebujejo kvinoksifen kot aktivno snov, najpozneje do 27. junija 2019.
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 27 March 2020 at the latest.
Morebitno prehodno obdobje, ki ga države članice odobrijo v skladu s členom 46 Uredbe (ES) št. 1107/2009, je čim krajše, izteče pa se najpozneje 27. marca 2020.
Commission Directive 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to include quinoxyfen as active substance (OJ L 120, 24.4.2004, p. 39).
Direktiva Komisije 2004/60/ES z dne 23. aprila 2004 o spremembah Direktive Sveta 91/414/EGS zaradi vključitve kvinoksifena kot aktivne snovi (UL L 120, 24.4.2004, str. 39).
Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen.
EFSA (Evropska agencija za varnost hrane), 2018.
DOI: 10.2903/j.efsa.2018.5085.
Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen (Strokovni pregled usmerjene ocene tveganja pesticidne aktivne snovi kvinoksifen).
Commission Implementing Regulation (EU) 2018/1915
Izvedbena uredba Komisije (EU) 2018/1915
approving the active substance Metschnikowia fructicola strain NRRL Y-27328 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobritvi aktivne snovi Metschnikowia fructicola, sev NRRL Y-27328, v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet in spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 13(2) thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS ter zlasti člena 13(2) Uredbe,
In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Koppert B.V. submitted to France on 30 September 2014 an application for the approval of the active substance Metschnikowia fructicola strain NRRL Y-27328.
V skladu s členom 7(1) Uredbe (ES) št. 1107/2009 je družba Koppert B.V. 30. septembra 2014 Franciji predložila zahtevek za odobritev aktivne snovi Metschnikowia fructicola, sev NRRL Y-27328.
In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 3 June 2015 of the admissibility of the application.
V skladu s členom 9(3) navedene uredbe je Francija kot država članica poročevalka 3. junija 2015 obvestila vlagatelja, druge države članice, Komisijo in Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) o dopustnosti zahtevka.
On 17 October 2016, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Država članica poročevalka je 17. oktobra 2016 Komisiji predložila osnutek poročila o oceni, pri čemer je en izvod poslala Agenciji, v katerem je ocenila, ali se za navedeno aktivno snov lahko pričakuje, da bo izpolnjevala merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009.
In accordance with Article 12(3) of that Regulation, it requested on 20 March 2017 that the applicant supply additional information to the Member States, the Commission and the Authority.
V skladu s členom 12(3) navedene uredbe je 20. marca 2017 zahtevala, da vložnik predloži dodatne informacije državam članicam, Komisiji in Agenciji.
The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 12 September 2017.
Država članica poročevalka je 12. septembra 2017 Agenciji predložila oceno dodatnih informacij v obliki posodobljenega osnutka poročila o oceni.
On 24 November 2017 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Metschnikowia fructicola strain NRRL Y-27328 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Agencija je 24. novembra 2017 vlagatelju, državam članicam in Komisiji poslala svoj sklep o tem, ali se za aktivno snovi Metschnikowia fructicola, sev NRRL Y-27328, lahko pričakuje, da bo izpolnjevala merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009.
On 20 July 2018, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Metschnikowia fructicola strain NRRL Y-27328 and a draft Regulation providing that Metschnikowia fructicola strain NRRL Y-27328 is approved.
Komisija je 20. julija 2018 Stalnemu odboru za rastline, živali, hrano in krmo predložila poročilo o pregledu Metschnikowia fructicola, sev NRRL Y-27328, in osnutek uredbe o odobritvi Metschnikowia fructicola, sev NRRL Y-27328.
It is therefore appropriate to approve Metschnikowia fructicola strain NRRL Y-27328.
Zato je primerno, da se Metschnikowia fructicola, sev NRRL Y-27328, odobri.
The active substance Metschnikowia fructicola strain NRRL Y-27328, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov Metschnikowia fructicola, sev NRRL Y-27328, kot je opredeljena v Prilogi I, se odobri v skladu s pogoji iz navedene priloge.
Conclusion on the peer review of the pesticide risk assessment of the active substance Metschnikowia fructicola NRRL Y-27328 EFSA Journal 2017;15(12):5084, 19 pp. doi:10.2903/j.efsa.2017.5084.
PRILOGA I
Expiration of approval
Metschnikowia fructicola, sev NRRL Y-27328
Specific provisions
Pristopna številka v zbirki kmetijskih raziskovalnih storitev (Agriculture Service Culture Collection) v Nacionalnem centru za raziskave rabe v kmetijstvu v Peoria, Illinois, ZDA
Metschnikowia fructicola strain NRRL Y-27328
Ni relevantno.
Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA
Najnižja koncentracija:
Not applicable
27. december 2018
Minimum concentration:
27. december 2028
27 December 2018
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu snovi Metschnikowia fructicola, sev NRRL Y-27328, ter zlasti dodatka I in II k poročilu.
27 December 2028
V tej celoviti oceni morajo biti države članice zlasti pozorne na:
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metschnikowia fructicola strain NRRL Y-27328, and in particular Appendices I and II thereof, shall be taken into account.
zaščito izvajalcev in delavcev ob upoštevanju, da Metschnikowia fructicola, sev NRRL Y-27328, lahko povzroča preobčutljivost.
In this overall assessment Member States shall pay particular attention to:
Proizvajalec zagotovi strogo vzdrževanje okoljskih pogojev in analize nadzora kakovosti med proizvodnim postopkom.
the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.
Pogoji uporabe po potrebi vključujejo ukrepe za zmanjšanje tveganja.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.
Več podrobnosti o aktivni snovi in njenih lastnostih je v poročilu o pregledu.
Further details on identity and specification of active substance are provided in the review report.
V delu B Priloge k Izvedbeni uredbi (EU) št. 540/2011 se doda naslednji vnos:
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
EFSA (Evropska agencija za varnost hrane), 2018.
Conditions of use shall include risk mitigation measures, where appropriate.’
Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo Metschnikowia fructicola NRRL Y-27328.
Commission Implementing Regulation (EU) 2018/1916
Izvedbena uredba Komisije (EU) 2018/1916
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance bispyribac
o spremembi Izvedbene uredbe (EU) št. 540/2011 glede podaljšanja obdobja odobritve aktivne snovi bispiribak
Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 sets out the active substances approved under Regulation (EC) No 1107/2009.
Del B Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011 določa aktivne snovi, ki so odobrene v skladu z Uredbo (ES) št. 1107/2009.
The approval period of the active substance bispyribac will expire on 31 July 2021.
Obdobje odobritve aktivne snovi bispiribak poteče 31. julija 2021.
Application for the renewal of the approval of the active substance was submitted in accordance with Commission Implementing Regulation (EU) No 844/2012.
Vloga za obnovitev odobritve aktivne snovi je bila vložena v skladu z Izvedbeno uredbo Komisije (EU) št. 844/2012.
However, the approval is likely to expire for reasons beyond the control of the applicant before a decision on the renewal of the approval has been taken.
Vendar bo odobritev verjetno potekla zaradi razlogov, na katere vložnik nima vpliva, preden bo sprejeta odločitev o obnovitvi odobritve.
It is therefore necessary to extend the approval period in accordance with Article 17 of Regulation (EC) No 1107/2009.
Zato je treba podaljšati obdobje odobritve v skladu s členom 17 Uredbe (ES) št. 1107/2009.
In view of the time and resources necessary for completing the assessment of applications for renewal of approvals of large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016)6104 established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.
Ob upoštevanju časa in virov, ki so potrebni za dokončanje ocene vlog za obnovitev odobritev velikega števila aktivnih snovi, katerih odobritev bo potekla med letoma 2019 in 2021, je bil z Izvedbenim sklepom Komisije C(2016) 6104 oblikovan delovni program, ki združuje podobne aktivne snovi ter določa prednostne naloge na podlagi skrbi za varovanje zdravja ljudi in živali ali okolja, kot je določeno v členu 18 Uredbe (ES) št. 1107/2009.
As the active substance included in this Regulation does not fall in the prioritised categories of Implementing Decision C(2016)6104, the approval period should be extended by two years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making.
Ker aktivna snov, vključena v to uredbo, ne spada v prednostno kategorijo Izvedbenega sklepa C(2016) 6104, bi bilo treba obdobje odobritve podaljšati za dve leti, ob upoštevanju sedanjega datuma poteka veljavnosti, dejstva, da je treba v skladu s členom 6(3) Izvedbene uredbe (EU) št. 844/2012 dopolnilno dokumentacijo za aktivno snov predložiti najpozneje 30 mesecev pred potekom odobritve, nujnosti zagotovitve uravnotežene razdelitve odgovornosti in nalog med državami članicami poročevalkami in soporočevalkami ter razpoložljivih virov, potrebnih za ocenjevanje in odločanje.
It is therefore appropriate to extend the approval period of the active substance bispyribac by two years.
Zato je primerno podaljšati obdobje odobritve aktivne snovi bispiribak za dve leti.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
Glede na cilj prvega odstavka člena 17 Uredbe (ES) št. 1107/2009 v zvezi s primeri, v katerih dopolnilna dokumentacija v skladu z Izvedbeno uredbo (EU) št. 844/2012 ni bila predložena najpozneje 30 mesecev pred ustreznim datumom poteka veljavnosti iz Priloge k tej uredbi, Komisija določi isti datum poteka veljavnosti kot pred to uredbo ali prvi možni datum po tem.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.
Glede na cilj prvega odstavka člena 17 Uredbe (ES) št. 1107/2009 v zvezi s primeri, v katerih Komisija sprejme uredbo, ki določa, da se odobritev aktivne snovi iz Priloge k tej uredbi ne obnovi, ker merila za odobritev niso izpolnjena, Komisija določi isti datum poteka veljavnosti kot pred to uredbo ali datum začetka veljavnosti uredbe, ki določa, da se odobritev aktivne snovi ne obnovi, odvisno od tega, kateri datum je poznejši.
Part B of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
Del B Priloge k Izvedbeni uredbi (EU) št. 540/2011 se spremeni:
In the sixth column, expiration of approval, of row 1, Bispyribac, the date is replaced by ‘31 July 2023’.
v šestem stolpcu vrstice 1 se za bispiribak datum veljavnosti registracije nadomesti z „31. julij 2023“.
Commission Implementing Regulation (EU) 2018/1917
Izvedbena uredba Komisije (EU) 2018/1917
concerning the non-renewal of approval of the active substance flurtamone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
o neobnovitvi odobritve aktivne snovi flurtamon v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet ter o spremembi Izvedbene uredbe Komisije (EU) št. 540/2011
Commission Directive 2003/84/EC included flurtamone as an active substance in Annex I to Council Directive 91/414/EEC.
Flurtamon je bil z Direktivo Komisije 2003/84/ES vključen v Prilogo I k Direktivi Sveta 91/414/EGS kot aktivna snov.
The approval of the active substance flurtamone, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019.
Odobritev aktivne snovi flurtamon, kot je določena v delu A Priloge k Izvedbeni uredbi (EU) št. 540/2011, preneha veljati 31. oktobra 2019.
An application for the renewal of the approval of flurtamone was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
Zahtevek za obnovitev odobritve flurtamona je bil predložen v skladu s členom 1 Izvedbene uredbe Komisije (EU) št. 844/2012 v roku, določenem v navedenem členu.
The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 29 May 2015.
Država članica poročevalka je pripravila poročilo o oceni obnovitve v posvetovanju z državo članico soporočevalko ter ga 29. maja 2015 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
On 10 August 2017 the Authority communicated to the Commission its conclusion on whether flurtamone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Agencija je 10. avgusta 2017 Komisiji predložila svoj sklep o tem, ali se za flurtamon lahko pričakuje, da bo izpolnjeval merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009.
In particular, it concluded that it is not possible to exclude the mutagenic potential of flurtamone based on the available information and that no final health-based reference values could be set.
Ugotovila je zlasti, da na podlagi razpoložljivih informacij ni mogoče izključiti mutagenosti flurtamona in da ni mogoče določiti končnih referenčnih vrednosti za varovanje zdravja.
Consequently, the Authority concluded that the consumer and non-dietary risk asessements could not be conducted.
Zato je sklenila, da ni mogoče izvesti ocene tveganja za potrošnike in ocene neprehranskega tveganja.
In addition, the Authority concluded that the overall consumer risk assessment for exposure to metabolite trifluoroacetic acid, predicted to occur in groundwater in all pertinent scenarios and as a residue in plants, could not be finalised due to a number of deficiencies in the dossier.
Poleg tega je ugotovila, da zaradi številnih pomanjkljivosti v dokumentaciji ni mogoče dokončati splošne ocene tveganja za potrošnike zaradi izpostavljenosti metabolitu trifluoroocetne kisline, za katerega vsi ustrezni scenariji predvidevajo, da bi bil prisoten v podzemni vodi in kot ostanek v rastlinah.
Furthermore, the Authority concluded that the assessment of endocrine disrupting properties could not be completed based on the available studies.
Ugotovila je tudi, da na podlagi študij, ki so na voljo, ni mogoče dokončati ocene lastnosti endokrinega motilca.
However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.
Vendar kljub argumentom, ki jih je predložil vlagatelj, pomislekov v zvezi z aktivno snovjo ni bilo mogoče odpraviti.
Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
Na podlagi tega je bilo za eno ali več reprezentativnih uporab vsaj enega fitofarmacevtskega sredstva ugotovljeno, da merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009 niso izpolnjena.
It is therefore appropriate not to renew the approval of the active substance flurtamone in accordance with Article 20(1)(b) of that Regulation.
Zato je v skladu s členom 20(1)(b) navedene uredbe primerno, da se odobritev aktivne snovi flurtamon ne obnovi.
Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing flurtamone.
Državam članicam bi bilo treba zagotoviti dovolj časa za preklic registracij fitofarmacevtskih sredstev, ki vsebujejo flurtamon.
For plant protection products containing flurtamone, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 27 March 2020.
Za fitofarmacevtska sredstva, ki vsebujejo flurtamon in pri katerih države članice odobrijo morebitno prehodno obdobje v skladu s členom 46 Uredbe (ES) št. 1107/2009, bi se moralo navedeno obdobje izteči najpozneje 27. marca 2020.
Commission Implementing Regulation (EU) 2018/1262 extended the expiry date of flurtamone to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance.
Z Izvedbeno uredbo Komisije (EU) 2018/1262 je bil datum veljavnosti odobritve flurtamona podaljšan do 31. oktobra 2019, da bi se omogočil zaključek postopka obnovitve pred prenehanjem odobritve navedene snovi.
However, given that a decision has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
Ker pa je bil sklep sprejet pred tem podaljšanim datumom veljavnosti odobritve, bi se morala ta uredba začeti uporabljati čim prej.
This Regulation does not prevent the submission of a further application for the approval of flurtamone pursuant to Article 7 of Regulation (EC) No 1107/2009.
Ta uredba ne vpliva na predložitev ponovnega zahtevka za odobritev flurtamona v skladu s členom 7 Uredbe (ES) št. 1107/2009.
The approval of the active substance flurtamone is not renewed.
Odobritev aktivne snovi flurtamon se ne obnovi.
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 64, on flurtamone, is deleted.
V delu A Priloge k Izvedbeni uredbi (EU) št. 540/2011 se vrstica 64 za flurtamon črta.
Member States shall withdraw authorisations for plant protection products containing flurtamone as active substance by 27 June 2019 at the latest.
Države članice prekličejo registracije fitofarmacevtskih sredstev, ki vsebujejo flurtamon kot aktivno snov, najpozneje do 27. junija 2019.