natgillin/translations-raw huggingface dataset:
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to diclofop 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 za diklofop iz Priloge I k navedeni direktivi izpolnjeni, razen pogojev iz dela B besedila o navedeni aktivni snovi, in ali ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi pod pogoji iz člena 13 navedene direktive.
By way of derogation from paragraph 1, for each authorised plant protection product containing diclofop 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 31 May 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 diclofop.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje diklofop kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. maja 2011, po enotnih načelih 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 iz Priloge I k navedeni direktivi o diklofopu.
in the case of a product containing diclofop as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje diklofop kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo, ali
in the case of a product containing diclofop as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 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 diklofop kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 2015 ali do datuma, določenega za tako 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 diclofop.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo diklofop.
[74 pp.]. doi:10.2903/j.efsa.2010.1718 Available online: www.efsa.europa.eu
[74 str.]. doi:10.2903/j.efsa.2010.1718. Na voljo na spletu: www.efsa.europa.eu.
CAS No 40843-25-2 (parent)
Št. CAS 40843-25-2 (izhodna spojina)
CAS No 257-141-8 (diclofop-methyl)
Št. CAS 257-141-8 (diklofop-metil)
CIPAC No 358 (parent)
Št. CIPAC 358 (izhodna spojina)
CIPAC No 358.201 (diclofop-methyl)
Št. CIPAC 358.201 (diklofop-metil)
≥ 980 g/kg (expressed as diclofop-methyl)
≥ 980 g/kg (izražena kot diklofop-metil)
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo ugotovitve iz poročila o pregledu diklofopa ter zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 11. marca 2011.
In this overall assessment Member States shall:
V tej celoviti oceni morajo biti države članice zlasti pozorne na:
pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment,
zaščito izvajalcev in delavcev ter vključijo kot pogoj za registracijo uporabo ustrezne osebne zaščitne opreme,
pay particular attention to the risk to aquatic organisms and non-target plants and require risk mitigation measures to be applied.
tveganje za vodne organizme in neciljne rastline ter zahtevajo sprejetje ukrepov za zmanjšanje tveganja.
a metabolism study on cereals;
študiji o presnovi žit;
an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers.
posodobitvi ocene tveganja glede morebitnih vplivov na okolje prevladujoče razgradnje/pretvorbe izomerov.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest 2 years after the adoption of a specific guidance document on evaluation of isomers mixtures.’
Zadevne države članice zagotovijo, da vlagatelj Komisiji predloži informacije iz točke (a) do 31. maja 2013 in informacije iz točke (b) najpozneje v dveh letih po sprejetju posebnih napotkov za oceno mešanic izomerov.“
Decision 2008/934/EC provides for the non-inclusion of diclofop-methyl and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev diklofop-metila in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning diclofop-methyl in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico o diklofop-metilu.
Commission Implementing Directive 2011/46/EU
Izvedbena direktiva Komisije 2011/46/EU
amending Council Directive 91/414/EEC to include hexythiazox as active substance and amending Commission Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve heksitiazoksa kot aktivne snovi in spremembi Odločbe Komisije 2008/934/ES
That list included hexythiazox.
Navedeni seznam je vključeval heksitiazoks.
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 hexythiazox.
Zato je bila za nevključitev heksitiazoksa 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 registracije fitofarmacevtskih sredstev, ki vsebujejo navedene snovi [4].
The application was submitted to Finland, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002.
Zahtevek je bil predložen Finski, ki je bila z Uredbo (ES) št. 1490/2002 imenovana za državo članico poročevalko.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 20 October 2009.
Navedeno poročilo je 20. oktobra 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 hexythiazox to the Commission on 7 September 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 7. septembra 2010 [6] Komisiji predstavila svoj sklep o heksitiazoksu.
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 11 March 2011 in the format of the Commission review report for hexythiazox.
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 11. marca 2011 v obliki poročila Komisije o pregledu heksitiazoksa.
It has appeared from the various examinations made that plant protection products containing hexythiazox 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 heksitiazoks, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti pri uporabah, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include hexythiazox 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 heksitiazoks primerno vključiti v Prilogo I, da se v skladu z določbami navedene direktive lahko v vseh državah članicah registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Therefore, it is appropriate to require that the applicant submit information confirming the risk assessment for the toxicological relevance and the potential occurrence of the metabolite PT-1-3 [7] in processed commodities, the potential adverse effects of hexythiazox on bee brood and the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.
Zato je primerno zahtevati, da vlagatelj predloži informacije, ki potrjujejo oceno tveganja za toksikološko pomembnost in možen pojav metabolita PT-1-3 [7] v predelanih proizvodih, možne škodljive učinke heksitiazoksa na čebeljo zalego in možen učinek preferenčnega razpada in/ali pretvorbe zmesi izomerov na oceno tveganja za delavce, oceno tveganja za potrošnike in okolje.
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 6 months after inclusion to review existing authorisations of plant protection products containing hexythiazox 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 heksitiazoks, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 Direktive in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi spremenijo, nadomestijo ali prekličejo.
The experience gained from previous 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 [8] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje iz prejšnjih 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 [8], so pokazale, da se pri razlagi obveznosti imetnikov veljavnih registracij lahko pojavijo težave pri dostopu do podatkov.
The line concerning hexythiazox in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica o heksitiazoksu.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing hexythiazox as an active substance by 30 November 2011.
Države članice v skladu z Direktivo 91/414/EGS do 30. novembra 2011 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo heksitiazoks kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to hexythiazox 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 za heksitiazoks iz Priloge I k navedeni direktivi izpolnjeni, razen pogojev iz dela B besedila o navedeni aktivni snovi, in ali ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi pod pogoji iz člena 13 navedene direktive.
By way of derogation from paragraph 1, for each authorised plant protection product containing hexythiazox 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 31 May 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 hexythiazox.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje heksitiazoks kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. maja 2011, po enotnih načelih 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 iz Priloge I k navedeni direktivi o heksitiazoksu.
in the case of a product containing hexythiazox as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje heksitiazoks kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo; ali
in the case of a product containing hexythiazox as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 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 heksitiazoks kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 2015 ali do datuma, določenega za tako 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 hexythiazox.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo heksitiazoks.
[78 pp.]. doi:10.2903/j.efsa.2010.1722.
[78 str.]. doi:10.2903/j.efsa.2010.1722.
(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl- 1,3-thiazolidin-2-one.
(4S,5S)-5-(4-klorofenil)-4-metil-1,3-tiazolidin-2-on in (4R,5R)-5-(4-klorofenil)-4-metil-1,3-tiazolidin-2-on.
CAS No 78587-05-0
Št. CAS: 78587-05-0
CIPAC No 439
Št. CIPAC: 439
(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide
(4RS,5RS)-5-(4-klorofenil)-N-cikloheksil-4-metil-2-okso-1,3-tiazolidin-3-karboksamid
1 June 2011
(1:1 zmes (4R, 5R) in (4S, 5S)) 1. junij 2011
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi iz poročila o pregledu heksitiazoksa ter zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 11. marca 2011.
Conditions of use shall include risk mitigation measures, where appropriate,
Pogoji za uporabo po potrebi vključujejo ukrepe za zmanjšanje tveganja,
the operators and workers safety.
varnost izvajalcev in delavcev.
Conditions of use shall include protective measures, where appropriate.
Pogoji uporabe po potrebi vključujejo varnostne ukrepe.
the toxicological relevance of the metabolite PT-1-3 [2];
toksikološki pomembnosti metabolita PT-1-3 [2];
the potential occurrence of the metabolite PT-1-3 in processed commodities;
možnem pojavu metabolita PT-1-3 v predelanih proizvodih;
the potential adverse effects of hexythiazox on bee brood;
možnih škodljivih učinkih heksitiazoksa na čebeljo zalego;
the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.
možnem učinku preferenčnega razpada in/ali pretvorbe zmesi izomerov na oceno tveganja za delavce, oceno tveganja za potrošnike in okolje.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) 2 years after the adoption of specific guidance.’
Zadevne države članice zagotovijo, da vlagatelj Komisiji predloži informacije iz točk (a), (b) in (c) do 31. maja 2013, informacije iz točke (d) pa dve leti po sprejetju posebnih smernic.“
(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.
(4S,5S)-5-(4-klorofenil)-4-metil-1,3-tiazolidin-2-on in (4R,5R)-5-(4-klorofenil)-4-metil-1,3-tiazolidin-2-on.
Decision 2008/934/EC provides for the non-inclusion of hexythiazox and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev heksitiazoksa in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning hexythiazox in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico o heksitiazoksu.
Commission Implementing Directive 2011/47/EU
Izvedbena direktiva Komisije 2011/47/EU
amending Council Directive 91/414/EEC to include aluminium sulphate as active substance and amending Commission Decision 2008/941/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve aluminijevega sulfata kot aktivne snovi in spremembi Odločbe Komisije 2008/941/ES
That list included aluminium sulphate.
Navedeni seznam vključuje aluminijev sulfat.
In accordance with Article 24e of Regulation (EC) No 2229/2004 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report.
V skladu s členom 24e Uredbe (ES) št. 2229/2004 je prijavitelj v dveh mesecih od prejema osnutka poročila o oceni umaknil predlog za vključitev navedene aktivne snovi v Prilogo I k Direktivi 91/414/EGS.
Consequently, Commission Decision 2008/941/EC of 8 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 aluminium sulphate.
Zato je bila za nevključitev aluminijevega sulfata sprejeta Odločba Komisije 2008/941/ES z dne 8. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracije fitofarmacevtskih sredstev, ki vsebujejo navedene snovi [4].
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter the ‘applicant’) submitted a new application requesting the application of the accelerated procedure 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 2229/2004.
Zahtevek je bil vložen pri Nizozemski, ki je bila z Uredbo (ES) št. 2229/2004 imenovana za državo članico poročevalko.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 9 March 2010.
Navedeno poročilo je 9. marca 2010 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 aluminium sulphate to the Commission on 28 October 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 28. oktobra 2010 Komisiji predložila svoj sklep o aluminijevem sulfatu [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 11 March 2011 in the format of the Commission review report for aluminium sulphate.
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 11. marca 2011 v obliki poročila Komisije o pregledu aluminijevega sulfata.
It has appeared from the various examinations made that plant protection products containing aluminium sulphate 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 aluminijev sulfat, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti pri uporabah, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.