natgillin/translations-raw huggingface dataset:
On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1) (b), (c), (d) and (e) of Directive 91/414/EEC.
Na podlagi navedene ocene države članice presodijo, ali sredstvo izpolnjuje pogoje iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414/EGS.
in the case of a product containing quinmerac as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or
če sredstvo vsebuje kvinmerak kot edino aktivno snov, najpozneje do 30. aprila 2015 po potrebi spremenijo ali prekličejo registracijo; ali
in the case of a product containing quinmerac as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
če sredstvo vsebuje kvinmerak kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 30. aprila 2015 ali do datuma, določenega za takšno spremembo ali preklic v ustreznih direktivah, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
Done at Brussels, 6 November 2010.
V Bruslju, 6. novembra 2010
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance quinmerac.
Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo kvinmerak.
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC.
Na koncu razpredelnice v Prilogi I k Direktivi 91/414/EGS se doda naslednje besedilo:
CAS No: 90717-03-6
Št. CAS: 90717-03-6
CIPAC No: 563
Št. CIPAC: 563
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za kvinmerak, in zlasti dodatkov I in II k poročilu, kot je bilo dokončno oblikovano v Stalnem odboru za prehranjevalno verigo in zdravje živali 28. oktobra 2010.
the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;
zaščito podtalnice, če se aktivna snov uporablja na območjih z občutljivimi tlemi in/ali podnebnimi razmerami;
the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops
prehransko izpostavljenost potrošnikov ostankom kvinmeraka (in njegovih metabolitov) v posevkih, ki sledijo v kolobarju;
the risk to aquatic organisms and the long term risk for earthworms.
tveganje za vodne organizme in dolgoročno tveganje za deževnike.
The Member States concerned shall request the submission of information as regards:
Zadevne države članice zahtevajo predložitev informacij glede:
the potential of plant metabolism to result in an opening of the quinoline ring;
možnosti, da se zaradi metabolizma rastline odpre kinolinski obroč;
residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5.
ostankov v posevkih, ki sledijo v kolobarju, in dolgoročnega tveganja za deževnike zaradi metabolita BH 518-5.
They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.’
Države članice zagotovijo, da vlagatelj Komisiji predloži takšne informacije do 30. aprila 2013.“
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing quinmerac to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki izhajajo iz vključitve aktivne snovi v Prilogo I, je državam članicam treba omogočiti, da v šestih mesecih po vključitvi snovi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo kvinmerak, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi spremenijo, nadomestijo ali prekličejo.
Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances provides for the non-inclusion of quinmerac and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba Komisije 2008/934/ES z dne 5. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo te snovi, določa nevključitev kvinmeraka in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning quinmerac in the Annex to that Decision.
V Prilogi k navedeni Odločbi je treba črtati vrstico, ki zadeva kvinmerak.
Commission Directive 2010/90/EU
Direktiva Komisije 2010/90/EU
amending Council Directive 91/414/EEC to include pyridaben as active substance and amending Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve piridabena kot aktivne snovi in o spremembi Odločbe 2008/934/ES
That list included pyridaben.
Navedeni seznam je vključeval piridaben.
Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances [4] was adopted on the non-inclusion of pyridaben.
Zato je bila v zvezi z nevključitvijo piridabena sprejeta Odločba Komisije 2008/934/ES z dne 5. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo te snovi [4].
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [5].
Prvotni prijavitelj (v nadaljnjem besedilu: vlagatelj) je v skladu s členom 6(2) Direktive 91/414/EGS vložil nov zahtevek za uporabo pospešenega postopka iz členov 14 do 19 Uredbe Komisije (ES) št. 33/2008 z dne 17. januarja 2008 o podrobnih pravilih za izvajanje Direktive Sveta 91/414/EGS glede rednega in pospešenega postopka za oceno aktivnih snovi, ki so bile del programa dela iz člena 8(2) navedene direktive, vendar niso bile vključene v Prilogo I [5].
The application was submitted to the Netherlands, which had been designated rapporteur Member State by Regulation (EC) No 451/2000.
Zahtevek je bil predložen Nizozemski, ki je bila z Uredbo (ES) št. 451/2000 imenovana za državo članico poročevalko.
The Netherlands evaluated the additional data submitted by the applicant and prepared an additional report.
Nizozemska je ocenila dodatne podatke, ki jih je predložil vlagatelj, in pripravila dodatno poročilo.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 15 June 2009.
Navedeno poročilo je 15. junija 2009 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on pyridaben to the Commission on 28 May 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 28. maja 2010 Komisiji predstavila svoje sklepe o piridabenu [6].
The draft assessment report, the additional 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 28 October 2010 in the format of the Commission review report for pyridaben.
Osnutek poročila o oceni, dodatno poročilo in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 28. oktobra 2010 v obliki poročila Komisije o pregledu glede piridabena.
It has appeared from the various examinations made that plant protection products containing pyridaben may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo piridaben, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include pyridaben in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti piridaben v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Therefore, it is appropriate to require that the applicant submit further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the exposure to the aqueous photolysis metabolites W-1 and B-3, the long term risk for mammals, the assessment of fat soluble residues.
Zato je primerno zahtevati, da vlagatelj predloži dodatne informacije, ki potrjujejo izsledke ocene tveganja na podlagi najnovejših znanstvenih dognanj glede izpostavljenosti metabolitoma W-1 in B-3 v fotolizi vode, glede dolgoročnega tveganja za sesalce ter glede ocene ostankov, topnih v maščobi.
It is therefore appropriate to amend Decision 2008/934/EC accordingly.
Zato je primerno Odločbo 2008/934/ES ustrezno spremeniti.
The line concerning pyridaben in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica, ki zadeva piridaben.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing pyridaben as an active substance by 1 November 2011.
Države članice v skladu z Direktivo 91/414/EGS do 1. novembra 2011 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo piridaben kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to pyridaben are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
Do navedenega datuma zlasti preverijo, ali so pogoji iz Priloge I k navedeni direktivi v zvezi s piridabenom, z izjemo tistih iz dela B besedila o navedeni aktivni snovi, izpolnjeni in ali ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi v skladu s pogoji iz člena 13 navedene direktive.
By way of derogation from paragraph 1, for each authorised plant protection product containing pyridaben as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning pyridaben.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje piridaben kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 30. aprila 2011, v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414/EGS na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k navedeni direktivi, in ob upoštevanju dela B besedila o piridabenu iz Priloge I k navedeni direktivi.
in the case of a product containing pyridaben as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or
če sredstvo vsebuje piridaben kot edino aktivno snov, najpozneje do 30. aprila 2015 po potrebi spremenijo ali prekličejo registracijo; ali
in the case of a product containing pyridaben as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
če sredstvo vsebuje piridaben kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 30. aprila 2015 ali do datuma, določenega za takšno spremembo ali preklic v ustreznih direktivah, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance pyridaben.
Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo piridaben.
CAS No: 96489-71-3
Št. CAS: 96489-71-3
CIPAC No: 583
Št. CIPAC: 583
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za piridaben, in zlasti dodatkov I in II k poročilu, kot je bilo dokončno oblikovano v Stalnem odboru za prehranjevalno verigo in zdravje živali 28. oktobra 2010.
the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,
varnost izvajalcev ter zagotoviti, da je v pogojih uporabe po potrebi predpisana uporaba ustrezne osebne zaščitne opreme,
the risk to aquatic organisms and mammals,
tveganje za vodne organizme in sesalce,
the risk to non target arthropods including honeybees.
tveganje za neciljne členonožce, vključno s čebelami.
Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.
Pogoji registracije morajo vključevati ukrepe za zmanjšanje tveganja, uvesti pa je treba programe spremljanja, kadar so potrebni, da se preveri dejanska izpostavljenost medonosnih čebel piridabenu na območjih, ki jih intenzivno uporabljajo čebele za pašo ali čebelarji.
The Member States concerned shall request the submission of confirmatory information as regards:
Zadevne države članice zahtevajo predložitev potrditvenih informacij glede:
the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,
tveganja za vodni kompartment zaradi izpostavljenosti metabolitoma W-1 in B-3 v fotolizi vode,
the potential long term risk for mammals,
morebitnega dolgoročnega tveganja za sesalce,
the assessment of fat soluble residues.
ocene ostankov, topnih v maščobi.
They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.’
Države članice zagotovijo, da vlagatelj Komisiji predloži take informacije do 30. aprila 2013.“
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing pyridaben to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki izhajajo iz vključitve aktivne snovi v Prilogo I, je državam članicam treba omogočiti, da v šestih mesecih po vključitvi snovi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo piridaben, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi spremenijo, nadomestijo ali prekličejo.
Decision 2008/934/EC provides for the non-inclusion of pyridaben and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev piridabena in preklic registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning pyridaben in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico, ki zadeva piridaben.
Commission Directive 2010/91/EU
Direktiva Komisije 2010/91/EU
amending Council Directive 91/414/EEC to include metosulam as active substance and amending Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve metosulama kot aktivne snovi in o spremembi Odločbe 2008/934/ES
That list included metosulam.
Navedeni seznam je vključeval metosulam.
Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances [4] was adopted on the non-inclusion of metosulam.
Zato je bila v zvezi z nevključitvijo metosulama sprejeta Odločba Komisije 2008/934/ES z dne 5. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo te snovi [4].
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter “the applicant”) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [5].
Prvotni prijavitelj (v nadaljnjem besedilu: vlagatelj) je v skladu s členom 6(2) Direktive 91/414/EGS vložil nov zahtevek za uporabo pospešenega postopka iz členov 14 do 19 Uredbe Komisije (ES) št. 33/2008 z dne 17. januarja 2008 o podrobnih pravilih za izvajanje Direktive Sveta 91/414/EGS glede rednega in pospešenega postopka za oceno aktivnih snovi, ki so bile del programa dela iz člena 8(2) navedene direktive, vendar niso bile vključene v Prilogo I [5].
The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 451/2000.
Zahtevek je bil predložen Franciji, ki je bila z Uredbo (ES) št. 451/2000 imenovana za državo članico poročevalko.
France evaluated the additional data submitted by the applicant and prepared an additional report.
Francija je ocenila dodatne podatke, ki jih je predložil vlagatelj, in pripravila dodatno poročilo.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 7 August 2009.
Navedeno poročilo je 7. avgusta 2009 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on metosulam to the Commission on 23 April 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 23. aprila 2010 Komisiji predstavila svoje sklepe o metosulamu [6].
The draft assessment report, the additional 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 28 October 2010 in the format of the Commission review report for metosulam.
Osnutek poročila o oceni, dodatno poročilo in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 28. oktobra 2010 v obliki poročila Komisije o pregledu glede metosulama.
It has appeared from the various examinations made that plant protection products containing metosulam may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo metosulam, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include metosulam in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti metosulam v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Therefore, it is appropriate to require that the applicant submit further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02, potential genotoxicity of one impurity and on the specification of the active substance as manufactured.
Zato je primerno zahtevati, da vlagatelj predloži dodatne informacije, ki potrjujejo izsledke ocene tveganja na podlagi najnovejših znanstvenih dognanj glede morebitne odvisnosti adsorpcije tal od pH vrednosti, glede pronicanja v podtalnico in izpostavljenosti površinske vode, kar zadeva metabolita M01 in M02, glede morebitne genotoksičnosti ene nečistoče in glede specifikacije aktivne snovi, kot je bila proizvedena.