natgillin/translations-raw huggingface dataset:
Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen.
Sva razdoblja odgode koja države članice odobre u skladu s člankom 46.
EFSA Journal 2018;16(1):5085 [11 pp.].
Uredbe (EZ) br. 1107/2009 moraju biti što kraća i moraju isteći najkasnije 27. ožujka 2020.
DOI: 10.2903/j.efsa.2018.5085.
Članak 5.
EFSA Journal 2018;16(1):5085 [11 pp.].
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
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 odobravanju aktivne tvari Metschnikowia fructicola soj NRRL Y-27328 u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja i o izmjeni Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011
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.
U skladu s člankom 7. stavkom 1.
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.
Uredbe (EZ) br. 1107/2009 trgovačko društvo Koppert B.V. 30. rujna 2014.
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.
Francuskoj je podnijelo zahtjev za odobrenje aktivne tvari Metschnikowia fructicola soj NRRL Y-27328.
The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009.
U skladu s člankom 9. stavkom 3. te uredbe Francuska je, kao država članica izvjestiteljica, 3. lipnja 2015. obavijestila podnositelja zahtjeva, ostale države članice, Komisiju i Europsku agenciju za sigurnost hrane („Agencija”) o prihvatljivosti zahtjeva.
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.
Država članica izvjestiteljica 17. listopada 2016.
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.
Komisiji je dostavila nacrt izvješća o ocjeni, uz kopiju Agenciji, u kojem je ocijenila može li se očekivati da ta aktivna tvar ispunjava mjerila za odobravanje predviđena u članku 4.
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.
Uredbe (EZ) br. 1107/2009.
The Authority made its conclusion available to the public.
Agencija je postupila u skladu s člankom 12. stavkom 1.
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.
Uredbe (EZ) br. 1107/2009.
It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
U skladu s člankom 12. stavkom 3. te uredbe 20. ožujka 2017. zatražila je da podnositelj zahtjeva državama članicama, Komisiji i Agenciji dostavi dodatne informacije.
It is therefore appropriate to approve Metschnikowia fructicola strain NRRL Y-27328.
Država članica izvjestiteljica dostavila je Agenciji ocjenu dodatnih informacija 12. rujna 2017. u obliku ažuriranog nacrta izvješća o ocjeni.
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions.
Agencija je 24. studenoga 2017. podnositelju zahtjeva, državama članicama i Komisiji dostavila zaključak o tome može li se očekivati da aktivna tvar Metschnikowia fructicola soj NRRL Y-27328 ispunjava mjerila za odobravanje predviđena u članku 4.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 should be amended accordingly.
Uredbe (EZ) br. 1107/2009.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Agencija je svoj zaključak stavila na raspolaganje javnosti.
HAS ADOPTED THIS REGULATION:
Komisija je 20. srpnja 2018.
Article 1
Stalnom odboru za bilje, životinje, hranu i hranu za životinje dostavila izvješće o pregledu za tvar Metschnikowia fructicola soj NRRL Y-27328 i nacrt uredbe kojom se predviđa odobravanje tvari Metschnikowia fructicola soj NRRL Y-27328.
Approval of active substance
Za jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja koje sadržava tu aktivnu tvar, a posebno za uporabe koje su ispitane i detaljno opisane u izvješću o pregledu, utvrđeno je da su mjerila za odobravanje predviđena u članku 4.
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.
Uredbe (EZ) br. 1107/2009 ispunjena.
Article 2
Stoga je primjereno odobriti tvar Metschnikowia fructicola soj NRRL Y-27328.
Amendments to Implementing Regulation (EU) No 540/2011
U skladu s člankom 13. stavkom 2.
Article 3
U skladu s člankom 13. stavkom 4.
Entry into force
Uredbe (EZ) br. 1107/2009 trebalo bi na odgovarajući način izmijeniti Prilog Provedbenoj uredbi Komisije (EU) br. 540/2011.
Done at Brussels, 6 December 2018.
Članak 1.
For the Commission
Odobrenje aktivne tvari
The President
Aktivna tvar Metschnikowia fructicola soj NRRL Y-27328, kako je navedena u Prilogu I., odobrava se u skladu s uvjetima utvrđenima u tom prilogu.
OJ L 309, 24.11.2009, p. 1.
Članak 2.
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.
Prilog Provedbenoj uredbi (EU) br. 540/2011 mijenja se u skladu s Prilogom II. ovoj Uredbi.
Purity
Sastavljeno u Bruxellesu 6. prosinca 2018.
Specific provisions
SL L 309, 24.11.2009., str. 1.
Metschnikowia fructicola strain NRRL Y-27328
Provedbena uredba Komisije (EU) br. 540/2011 od 25. svibnja 2011. o provedbi Uredbe (EZ) br. 1107/2009 Europskog parlamenta i Vijeća u pogledu popisa odobrenih aktivnih tvari (SL L 153, 11.6.2011., str. 1.).
Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA
PRILOG I.
Not applicable
Uobičajeni naziv, identifikacijski brojevi
Minimum concentration:
Kemijski naziv prema IUPAC-u
27 December 2018
Čistoća
27 December 2028
Datum odobrenja
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.
Prestanak odobrenja
In this overall assessment Member States shall pay particular attention to:
Posebne odredbe
the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.
Metschnikowia fructicola soj NRRL Y-27328
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.
Referentni broj u zbirci kultura Službe za istraživanja u poljoprivredi (Agriculture Research Service Culture Collection) Nacionalnog centra za istraživanje uporaba u poljoprivredi (National center for agricultural utilisation research) – Peoria, Illinois, Sjedinjene Američke Države.
Further details on identity and specification of active substance are provided in the review report.
Najmanja koncentracija:
ANNEX II
27. prosinca 2018.
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
27. prosinca 2028.
Conditions of use shall include risk mitigation measures, where appropriate.’
Za provedbu jedinstvenih načela iz članka 29. stavka 6.
EFSA (European Food Safety Authority), 2018.
Uredbe (EZ) br. 1107/2009 moraju se uzeti u obzir zaključci izvješća o pregledu za aktivnu tvar Metschnikowia fructicola soj NRRL Y-27328, a posebno njegovi dodaci I. i II.
Jean-Claude Juncker
zaštitu korisnika sredstva i radnika, uzimajući u obzir da Metschnikowia fructicola soj NRRL Y-27328 može uzrokovati preosjetljivost.
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance bispyribac
o izmjeni Provedbene uredbe (EU) br. 540/2011 u pogledu produljenja roka valjanosti odobrenja aktivne tvari 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.
U dijelu B Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011 utvrđene su aktivne tvari odobrene na temelju Uredbe (EZ) br. 1107/2009.
The approval period of the active substance bispyribac will expire on 31 July 2021.
Rok valjanosti odobrenja aktivne tvari bispiribak istječe 31. srpnja 2021.
Application for the renewal of the approval of the active substance was submitted in accordance with Commission Implementing Regulation (EU) No 844/2012.
Podnesen je zahtjev za produljenje odobrenja aktivne tvari u skladu s Provedbenom uredbom Komisije (EU) br. 844/2012.
It is therefore necessary to extend the approval period in accordance with Article 17 of Regulation (EC) No 1107/2009.
Stoga je potrebno produljiti rok valjanosti odobrenja u skladu s člankom 17.
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.
S obzirom na vrijeme i sredstva koji su potrebni za dovršenje procjene zahtjevâ za produljenje odobrenja velikog broja aktivnih tvari za koje odobrenja istječu između 2019. i 2021., Provedbenom odlukom Komisije C(2016)6104 utvrđen je program rada u kojemu se grupiraju slične aktivne tvari i određuju prioriteti na temelju pitanjâ sigurnosti za zdravlje ljudi i životinja ili za okoliš, kako je predviđeno člankom 18.
It is therefore appropriate to extend the approval period of the active substance bispyribac by two years.
Uredbe (EZ) br. 1107/2009.
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.
Budući da aktivna tvar iz ove Uredbe nije obuhvaćena prioritetnim kategorijama u Provedbenoj odluci C(2016)6104, rok valjanosti odobrenja trebalo bi produljiti za dvije godine, uzimajući u obzir postojeći datum prestanka odobrenja, činjenicu da u skladu s člankom 6. stavkom 3.
As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.
Stoga je primjereno produljiti rok valjanosti odobrenja za aktivnu tvar bispiribak za dvije godine.
OJ L 309, 24.11.2009, p. 1.
Sastavljeno u Bruxellesu 6. prosinca 2018.
Part B of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
Provedbena uredba Komisije (EU) br. 844/2012 od 18. rujna 2012. o određivanju odredaba potrebnih za provedbu postupka obnavljanja odobrenja za aktivne tvari, kako je predviđeno Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja (SL L 252, 19.9.2012., str. 26.).
In the sixth column, expiration of approval, of row 1, Bispyribac, the date is replaced by ‘31 July 2023’.
Provedbena odluka Komisije оd 28. rujna 2016. o uspostavi programa rada za procjenu zahtjeva za produljenje odobrenja aktivnih tvari koja istječu u 2019., 2020. i 2021. u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća (SL C 357, 29.9.2016., str. 9.).
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 neproduljenju odobrenja aktivne tvari flurtamon u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja i o izmjeni Provedbene uredbe Komisije (EU) br. 540/2011
Commission Directive 2003/84/EC included flurtamone as an active substance in Annex I to Council Directive 91/414/EEC.
Direktivom Komisije 2003/84/EZ flurtamon je uvršten u Prilog I. Direktivi Vijeća 91/414/EEZ kao aktivna tvar.
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.
Odobrenje aktivne tvari flurtamon, kako je navedena u dijelu A Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011, istječe 31. listopada 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.
Zahtjev za produljenje odobrenja aktivne tvari flurtamon podnesen je u skladu s člankom 1.
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.
Provedbene uredbe (EU) br. 844/2012.
The Authority also made the supplementary summary dossier available to the public.
Država članica izvjestiteljica nakon savjetovanja s državom članicom suizvjestiteljicom pripremila je izvješće o ocjeni produljenja i dostavila ga 29. svibnja 2015.
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.
Europskoj agenciji za sigurnost hrane („Agencija”) i Komisiji.
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.
Agencija je uz to sažetak dodatne dokumentacije učinila dostupnim javnosti.
Consequently, the Authority concluded that the consumer and non-dietary risk asessements could not be conducted.
Agencija je 10. kolovoza 2017.
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.
Komisiji dostavila zaključak o tome može li se pretpostaviti da flurtamon ispunjava mjerila za odobravanje iz članka 4.
Furthermore, the Authority concluded that the assessment of endocrine disrupting properties could not be completed based on the available studies.
Uredbe (EZ) br. 1107/2009.
The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report.
Agencija je utvrdila konkretne bojazni.
The applicant submitted its comments, which have been carefully examined.
Konkretno, zaključeno je da nije moguće isključiti mutageni potencijal flurtamona na temelju dostupnih informacija i da nije moguće utvrditi konačne referentne vrijednosti u pogledu zdravstvene sigurnosti.
However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.
Agencija je stoga zaključila da nije bilo moguće provesti procjenu rizika za potrošače i procjenu rizika od neprehrambene izloženosti.
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.
Osim toga, Agencija je zaključila da ukupna procjena rizika za potrošače zbog izloženosti metabolitu trifluoroctene kiseline, za koji se predviđa da se može pojaviti u podzemnim vodama u svim relevantnim scenarijima i kao ostatak u biljkama, nije mogla biti dovršena zbog niza nedostataka u dokumentaciji.
It is therefore appropriate not to renew the approval of the active substance flurtamone in accordance with Article 20(1)(b) of that Regulation.
Nadalje, Agencija je zaključila da se ocjena svojstava endokrine disrupcije nije mogla dovršiti na temelju raspoloživih studija.
Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing flurtamone.
Provedbene uredbe (EU) br. 844/2012.
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.
Podnositelj zahtjeva podnio je primjedbe, koje su detaljno pregledane.
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.
Međutim, unatoč argumentima koje je iznio podnositelj zahtjeva, bojazni u pogledu te aktivne tvari nisu se mogle ukloniti.
However, given that a decision has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
Stoga za jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja nije utvrđeno da su mjerila za odobravanje predviđena člankom 4.
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.
Uredbe (EZ) br. 1107/2009 ispunjena.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Stoga je primjereno ne produljiti odobrenje za aktivnu tvar flurtamon u skladu s člankom 20. stavkom 1. točkom (b) te uredbe.
Article 1
Državama članicama trebalo bi dati dovoljno vremena da oduzmu odobrenja za sredstva za zaštitu bilja koja sadržavaju flurtamon.
Non-renewal of approval of active substance
Ako države članice u skladu s člankom 46.
The approval of the active substance flurtamone is not renewed.
Uredbe (EZ) br. 1107/2009 odobre razdoblje odgode za sredstva za zaštitu bilja koja sadržavaju flurtamon, to bi razdoblje trebalo isteći najkasnije 27. ožujka 2020.
Article 2
Provedbenom uredbom Komisije (EU) 2018/1262 rok važenja odobrenja za flurtamon produljen je do 31. listopada 2019. kako bi se postupak produljenja mogao završiti prije isteka odobrenja te tvari.
Amendment to Implementing Regulation (EU) No 540/2011
Međutim, s obzirom na to da je odluka donesena prije novog datuma isteka odobrenja, ova bi se Uredba trebala primijeniti što je prije moguće.
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 64, on flurtamone, is deleted.
Ovom se Uredbom ne dovodi u pitanje ponovno podnošenje zahtjeva za odobrenje flurtamona u skladu s člankom 7.
Member States shall withdraw authorisations for plant protection products containing flurtamone as active substance by 27 June 2019 at the latest.
DONIJELA JE OVU UREDBU:
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.
Odobrenje aktivne tvari flurtamon ne produljuje se.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
U dijelu A Priloga Provedbenoj uredbi (EU) br. 540/2011 briše se redak 64. o flurtamonu.
Done at Brussels, 6 December 2018.
Prijelazne mjere
For the Commission
Države članice oduzimaju odobrenja za sredstva za zaštitu bilja koja sadržavaju flurtamon kao aktivnu tvar najkasnije do 27. lipnja 2019.
Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (OJ L 247, 30.9.2003, p. 20).
Sva razdoblja odgode koja države članice odobre u skladu s člankom 46.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).
Uredbe (EZ) br. 1107/2009 moraju biti što kraća i moraju isteći najkasnije 27. ožujka 2020.
Conclusion on the updated peer review of the pesticide risk assessment of the active substance flurtamone.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
EFSA Journal 2017;15(8):4976, 25 pp. https://doi.org/10.2903/j.efsa.2017.4976.
Sastavljeno u Bruxellesu 6. prosinca 2018.
Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron.
Za Komisiju
Jean-Claude Juncker
SL L 309, 24.11.2009., str. 1.
Conclusion on the updated peer review of the pesticide risk assessment of the active substance flurtamone.
Direktiva Komisije 2003/84/EZ od 25. rujna 2003. o izmjeni Direktive Vijeća 91/414/EEZ radi uvrštavanja flurtamona, flufenaceta, jodosulfurona, dimetenamida-p, pikoksistrobina, fostiazata i siltiofama kao aktivnih tvari (SL L 247, 30.9.2003., str. 20.).
Having regard to Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items, and in particular Article 15(3) thereof,
uzimajući u obzir Uredbu Vijeća (EZ) br. 428/2009 od 5. svibnja 2009. o uspostavljanju režima Zajednice za kontrolu izvoza, prijenosa, brokeringa i provoza robe s dvojnom namjenom, a posebno njezin članak 15. stavak 3.,