natgillin/translations-raw huggingface dataset:
The assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 17 June 2011 in the format of the Commission review report for prohexadione.
Države članice in Komisija so osnutek poročila o oceni, dodatno poročilo in sklep Agencije pregledale v Stalnem odboru za prehranjevalno verigo in zdravje živali ter končno različico pripravile 17. junija 2011 v obliki poročila Komisije o pregledu proheksadiona.
It has appeared from the various examinations made that plant protection products containing prohexadione may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo proheksadion, lahko pričakuje, da bodo še naprej na splošno izpolnjevala zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to approve prohexadione.
Zato je primerno, da se proheksadion odobri.
A reasonable period should be allowed to elapse before approval in order to permit Member States and interested parties to prepare themselves to meet the new requirements resulting from the approval.
Pred odobritvijo je treba določiti primeren rok, da se bodo države članice in zainteresirane strani lahko pripravile na izpolnjevanje novih zahtev, ki bodo nastale z odobritvijo.
Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply.
Brez poseganja v obveznosti iz Uredbe (ES) št. 1107/2009, ki izhajajo iz odobritve, in ob upoštevanju posebnega položaja, ki je nastal s prehodom od Direktive 91/414/EGS k Uredbi (ES) št. 1107/2009, je treba upoštevati naslednje.
Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing prohexadione.
Državam članicam je treba po odobritvi omogočiti šestmesečno obdobje, da pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo proheksadion.
Member States should, as appropriate, vary, replace or withdraw authorisations.
Države članice morajo registracije po potrebi spremeniti, nadomestiti ali preklicati.
By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.
Z odstopanjem od navedenega roka je treba določiti daljše obdobje za predložitev in oceno celotne posodobljene dokumentacije iz Priloge III za vsako fitofarmacevtsko sredstvo in za vsako nameravano uporabo po enotnih načelih iz Direktive 91/414/EGS.
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [7] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje iz vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, ocenjenih na podlagi Uredbe Komisije (EGS) št. 3600/92 z dne 11. decembra 1992 o podrobnih pravilih za izvajanje prve faze delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet [7], so pokazale, da se lahko pri razlagi obveznosti imetnikov veljavnih registracij glede dostopa do podatkov pojavijo težave.
However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.
Vendar ta razjasnitev državam članicam ali imetnikom registracij ne nalaga novih obveznosti v primerjavi z doslej sprejetimi direktivami o spremembah Priloge I k navedeni direktivi ali uredbam, s katerimi so odobrene aktivne snovi.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
V skladu s členom 13(4) Uredbe (ES) št. 1107/2009 je treba ustrezno spremeniti Prilogo k Izvedbeni uredbi (EU) št. 540/2011.
In the interest of clarity, Commission Directive 2010/56/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of prohexadione as active substance [8] should be repealed.
Zaradi jasnosti je treba razveljaviti Direktivo Komisije 2010/56/EU z dne 20. avgusta 2010 o spremembi Priloge I k Direktivi Sveta 91/414/EGS zaradi vključitve proheksadiona kot aktivne snovi [8].
Approval of active substance
Odobritev aktivne snovi
The active substance prohexadione, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov proheksadion, kot je opredeljena v Prilogi I, je odobrena v skladu s pogoji iz navedene priloge.
Re-evaluation of plant protection products
Ponovna ocena fitofarmacevtskih sredstev
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing prohexadione as an active substance by 30 June 2012.
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 30. junija 2012 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo proheksadion kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Article 13(1) to (4) of Directive 91/414/EEC and Article 62 of Regulation (EC) No 1107/2009.
Do navedenega datuma morajo zlasti preveriti, ali so izpolnjeni pogoji iz Priloge I k tej uredbi, z izjemo tistih iz dela B stolpca o posebnih določbah navedene priloge, in ali ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz člena 13(1) do (4) Direktive 91/414/EGS ter člena 62 Uredbe (ES) št. 1107/2009.
By way of derogation from paragraph 1, for each authorised plant protection product containing prohexadione as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje proheksadion kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, in najpozneje do 31. decembra 2011 v skladu z enotnimi načeli iz člena 29(6) Uredbe (ES) št. 1107/2009 na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k Direktivi 91/414/EGS, in ob upoštevanju dela B stolpca o posebnih določbah Priloge I k tej uredbi ponovno ocenijo sredstvo.
On the basis of that evaluation, they shall determine whether the product still satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
Na podlagi navedene ocene države članice presodijo, ali sredstvo še vedno izpolnjuje pogoje iz člena 29(1) Uredbe (ES) št. 1107/2009.
in the case of a product containing prohexadione as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or
če sredstvo vsebuje proheksadion kot edino aktivno snov, najpozneje do 31. decembra 2015 po potrebi spremenijo ali prekličejo registracijo ali
in the case of a product containing prohexadione as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
če sredstvo vsebuje proheksadion kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. decembra 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih aktih, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS oziroma s katerimi so bile zadevne snovi odobrene, pri čemer se upošteva poznejši datum.
Amendments to Implementing Regulation (EU) No 540/2011
Spremembe Izvedbene uredbe (EU) št. 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Priloga k Izvedbeni uredbi (EU) št. 540/2011 se spremeni v skladu s Prilogo II k tej uredbi.
Directive 2010/56/EU is repealed.
Direktiva 2010/56/EU se razveljavi.
OJ L 153, 11.6.2011, p. 1.
UL L 153, 11.6.2011, str. 1.
OJ L 214, 9.8.2008, p. 70.
UL L 214, 9.8.2008, str. 70. [6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo proheksadion na zahtevo Evropske komisije.
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance prohexadione on request from the European Commission EFSA Journal 2010; 8(3):1555.
EFSA Journal 2010; 8(3):1555.
OJ L 220, 21.8.2010, p. 71.
UL L 220, 21.8.2010, str. 71.
Prohexadione
proheksadion
CAS No 127277-53-6 (prohexadione-calcium)
št. CAS 127277-53-6 (proheksadion-kalcij)
CIPAC No 567 (prohexadione)
št. CIPAC 567 (proheksadion)
No 567.020 (prohexadione-calcium)
št. 567 020 (proheksadion-kalcij)
1 January 2012
1. januar 2012
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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu proheksadiona in zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 17. junija 2011.
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
Priloga k Izvedbeni uredbi (EU) št. 540/2011 se spremeni:
in Part A, the entry relating to prohexadione is deleted;
V delu A se črta vnos za proheksadion.
in Part B, the following entry is added:
V delu B se doda naslednji vnos.
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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.’
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu proheksadiona in zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 17. junija 2011.“
The approval of prohexadione, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances [4], expires on 31 December 2011.
Odobritev proheksadiona, kot je določena v delu A Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011 z dne 25. maja 2011 o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede seznama registriranih aktivnih snovi [4], preneha veljati 31. decembra 2011.
A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of prohexadione in Annex I to Directive 91/414/EEC within the time period provided for in that Article.
Za podaljšanje vključitve proheksadiona v Prilogo I k Direktivi 91/414/EGS je bila vložena prijava v skladu s členom 4 Uredbe (ES) št. 737/2007 v roku iz navedenega člena.
The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 5 June 2009.
Država članica poročevalka je pripravila poročilo o oceni v posvetovanju z državo članice soporočevalko in ga 5. junija 2009 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.
Poleg ocene aktivne snovi navedeno poročilo vsebuje tudi seznam študij, na katerih je država članica poročevalka utemeljila oceno.
Commission Implementing Regulation (EU) No 703/2011
Izvedbena uredba Komisije (EU) št. 703/2011
approving the active substance azoxystrobin, 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 azoksistrobin 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
Azoxystrobin is listed in Annex I to Regulation (EC) No 737/2007.
Azoksistrobin je naveden v Prilogi I k Uredbi (ES) št. 737/2007.
The Authority presented its conclusion on the peer review of the risk assessment of azoxystrobin [6] to the Commission on 12 March 2010.
Agencija je 12. marca 2010 Komisiji predložila sklep o strokovnem pregledu ocene nevarnosti azoksistrobina [6].
The assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 17 June 2011 in the format of the Commission review report for azoxystrobin.
Države članice in Komisija so osnutek poročila o oceni, dodatno poročilo in sklep Agencije pregledale v Stalnem odboru za prehranjevalno verigo in zdravje živali ter končno različico pripravile 17. junija 2011 v obliki poročila Komisije o pregledu azoksistrobina.
It has appeared from the various examinations made that plant protection products containing azoxystrobin may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo azoksistrobin, lahko pričakuje, da bodo še naprej na splošno izpolnjevale zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to approve azoxystrobin.
Zato je primerno, da se azoksistrobin odobri.
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 and restrictions not provided for in the first inclusion in Annex I to Directive 91/414/EEC.
V skladu s členom 13(2) Uredbe (ES) št. 1107/2009 v povezavi s členom 6 Uredbe in ob upoštevanju trenutnega znanstvenega in tehničnega znanja je treba vključiti nekatere pogoje in omejitve, ki niso bili določeni pri prvi vključitvi v Prilogo I k Direktivi 91/414/EGS.
Based on the review report, which points out that for the active substance azoxystrobin notified by the main data submitter the manufacturing impurity toluene is of toxicological concern, a maximum level of 2 g/kg should, however, be set for that impurity in the technical material.
Na podlagi poročila o pregledu, po katerem je pri aktivni snovi azoksistrobin, ki jo je prijavil glavni predložitelj podatkov, proizvodna nečistoča toluen s toksikološkega vidika problematična, je za navedeno nečistočo treba določiti zgornjo mejo 2 g/kg v tehničnem materialu.
Without prejudice to the conclusion that azoxystrobin should be approved, it is, in particular, appropriate to require further confirmatory information.
Brez poseganja v sklep, da je treba azoksistrobin odobriti, je še zlasti primerno zahtevati dodatne podatke potrditvene narave.
Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing azoxystrobin.
Državam članicam je treba po odobritvi omogočiti šestmesečno obdobje, da pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo azoksistrobin.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
V skladu s členom 13(4) Uredbe (ES) št. 1107/2009 je treba ustrezno spremeniti Prilogo k Izvedbeni uredbi (EU) št. 540/2011.
In the interest of clarity, Commission Directive 2010/55/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance [8] should be repealed.
Zaradi jasnosti je treba razveljaviti Direktivo Komisije 2010/55/EU z dne 20. avgusta 2010 o spremembi Priloge I k Direktivi Sveta 91/414/EGS zaradi vključitve azoksistrobina kot aktivne snovi [8].
The active substance azoxystrobin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov azoksistrobin, kot je opredeljena v Prilogi I, je odobrena v skladu s pogoji iz navedene priloge.
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing azoxystrobin as an active substance by 30 June 2012.
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 30. junija 2012 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo azoksistrobin kot aktivno snov.
By way of derogation from paragraph 1, for each authorised plant protection product containing azoxystrobin as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje azoksistrobin kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, in najpozneje do 31. decembra 2011 v skladu z enotnimi načeli iz člena 29(6) Uredbe (ES) št. 1107/2009 na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k Direktivi 91/414/EGS, in ob upoštevanju dela B stolpca o posebnih določbah Priloge I k tej uredbi ponovno ocenijo sredstvo.
in the case of a product containing azoxystrobin as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or
če sredstvo vsebuje azoksistrobin kot edino aktivno snov, najpozneje do 31. decembra 2015 po potrebi spremenijo ali prekličejo registracijo ali
in the case of a product containing azoxystrobin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
če sredstvo vsebuje azoksistrobin kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. decembra 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih aktih, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS oziroma s katerimi so bile zadevne snovi odobrene, pri čemer se upošteva poznejši datum.
Directive 2010/55/EU is repealed.
Direktiva 2010/55/EU se razveljavi.
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance azoxystrobin.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo azoksistrobin.
[110 pp.]. doi:10.2903/j.efsa.2010.1542.
[110 str.]. doi:10.2903/j.efsa.2010.1542.
OJ L 220, 21.8.2010, p. 67.
UL L 220, 21.8.2010, str. 67.
Toluene maximum content 2 g/kg
toluen, največja vsebnost 2 g/kg
Z-isomer maximum content 25 g/kg
Z-izomer, največja vsebnost 25 g/kg
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 azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu azoksistrobin in zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 17. junija 2011.
In this overall assessment Member States shall pay particular attention to:
V tej celoviti oceni so države članice pozorne zlasti na:
the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data.
to, da je specifikacijo tehničnega materiala v tržni proizvodnji treba potrditi z ustreznimi analitskimi podatki.
The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;
Testni material, uporabljen v dokumentaciji o toksičnosti, je treba primerjati in preveriti glede na specifikacije tehničnega materiala;
The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.
Države članice morajo zagotoviti, da pogoji registracije po potrebi vključujejo ukrepe za zmanjšanje tveganja.
The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.
Zadevne države članice zahtevajo predložitev potrditvenih informacij glede ocene tveganja za podtalnico in vodne organizme.
The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
Prijavitelj državam članicam, Komisiji in Agenciji take informacije predloži do 31. decembra 2013.
in Part A, the entry relating to azoxystrobin is deleted;
V delu A se črta vnos za azoksistrobin.
The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.’
Prijavitelj državam članicam, Komisiji in Agenciji take informacije predloži do 31. decembra 2013.“