natgillin/translations-raw huggingface dataset:
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 1-decanol.
Zato je bila za nevključitev 1-dekanola 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].
The application was submitted to the United Kingdom, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004.
Zahtevek je bil vložen pri Združenem kraljestvu, ki je bilo z Uredbo (ES) št. 2229/2004 imenovano za državo članico poročevalko.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 December 2009.
Navedeno poročilo je 10. decembra 2009 predložilo 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 1-decanol to the Commission on 27 August 2010 [6].
Agencija je 27. avgusta 2010 v skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije Komisiji predložila svoje sklepe o 1-dekanolu [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 January 2011 in the format of the Commission review report for 1-decanol.
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. januarja 2011 v obliki poročila Komisije o pregledu 1-dekanola.
It has appeared from the various examinations made that plant protection products containing 1-decanol 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 1-dekanol, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti pri uporabah za tretiranje semena, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include 1-decanol 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 1-dekanol 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 confirmatory information as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.
Zato je primerno zahtevati od vlagatelja, da predloži potrditvene informacije o tveganju za vodne organizme in informacije, ki potrjujejo ocene o izpostavljenosti podtalnice, površinskih vod in usedlin.
The line concerning 1-decanol in the Annex to Decision 2008/941/EC is deleted.
V Prilogi k Odločbi 2008/941/ES se črta vrstica o 1-dekanolu.
By way of derogation from paragraph 1, for each authorised plant protection product containing 1-decanol 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 July 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 1-decanol.
Do navedenega datuma zlasti preverijo, ali so izpolnjeni pogoji iz Priloge I k navedeni direktivi v zvezi z 1-dekanolom, z izjemo tistih 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 v skladu s pogoji iz člena 13 navedene direktive. 2. Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje 1-dekanol kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. julija 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 1-dekanolu iz Priloge I k navedeni direktivi.
in the case of a product containing 1-decanol as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
Države članice nato:
in the case of a product containing 1-decanol 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 1-dekanol kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo ali (b) če sredstvo vsebuje 1-dekanol kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 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 1-decanol.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo 1-dekanol.
[42 pp.] doi:10.2903/j.efsa.2010.1715.
[42 str.]. doi:10.2903/j.efsa.2010.1715.
1-decanol
Čistost [1] Uveljavitev Veljavnost registracije Posebne določbe „340
CAS No: 112-30-1
1-dekanol Št. CAS: 112-30-1
CIPAC No: 831
Št. CIPAC: 831
Only uses as plant growth regulator.
Registrira se lahko samo kot rastni regulator.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 1-decanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu 1-dekanola ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 28. januarja 2011.
In this overall assessment Member States shall pay particular attention to:
V celoviti oceni morajo biti države članice zlasti pozorne na:
the risk to consumers from residues in case of use on food or feed crops,
tveganje za potrošnike zaradi ostankov pri uporabi na posevkih za hrano ali krmo,
the risk for operator and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,
tveganje za izvajalce tretiranja ter zagotovitev, da je v pogojih uporabe po potrebi predpisana uporaba ustrezne osebne zaščitne opreme,
the risk to aquatic organisms,
tveganje za vodne organizme,
the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application.
tveganje za neciljne členonožce in čebele, ki so lahko izpostavljeni aktivni snovi med pašo po cvetočem plevelu v posevkih ob uporabi.
Risk mitigation measures shall be applied, where appropriate.
Po potrebi se uporabijo ukrepi za zmanjšanje tveganja.
The Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.
Zadevne države članice zahtevajo predložitev potrditvenih informacij o tveganju za vodne organizme in informacij, ki potrjujejo ocene o izpostavljenosti podtalnice, površinskih vod in usedlin.
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 1-decanol 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 1-dekanol, 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 2008/941/EC provides for the non-inclusion of 1-decanol and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011.
Odločba 2008/941/ES določa nevključitev 1-dekanola in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning 1-decanol in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico o 1-dekanolu.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing 1-decanol as an active substance by 30 November 2011. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to 1-decanol 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.
Države članice v skladu z Direktivo 91/414/EGS do 30. novembra 2011 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo 1-dekanol kot aktivno snov.
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. Following that determination Member States shall:
Na podlagi navedene ocene države članice presodijo, ali sredstvo izpolnjuje pogoje iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414/EGS.
Common name, identification numbers IUPAC name Purity [1] Entry into force
Splošno ime, identifikacijske številke
Expiration of inclusion Specific provisions ‘340
Ime po IUPAC
Commission Directive 2011/34/EU
Direktiva Komisije 2011/34/EU
amending Council Directive 91/414/EEC to include flurochloridone as active substance and amending Commission Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve flurokloridona kot aktivne snovi in o spremembi Odločbe Komisije 2008/934/ES
That list included flurochloridone.
Navedeni seznam je vključeval flurokloridon.
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 flurochloridone.
Zato je bila za nevključitev flurokloridona 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].
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].
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 3 November 2009.
Navedeno poročilo je 3. novembra 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 flurochloridone to the Commission on 14 October 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 14. oktobra 2010 Komisiji predložila svoje sklepe o flurokloridonu [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 4 February 2011 in the format of the Commission review report for flurochloridone.
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 4. februarja 2011 v obliki poročila Komisije o pregledu flurokloridona.
It has appeared from the various examinations made that plant protection products containing flurochloridone 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 flurokloridon, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami za tretiranje semena, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include flurochloridone 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 flurokloridon 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 confirming: the relevance of impurities other than toluene, the compliance of ecotoxicological test material with the technical specifications, the relevance of the groundwater metabolite R42819 [7] and the potential endocrine disrupting properties of flurochloridone.
Zato je primerno zahtevati, da vlagatelj predloži dodatne informacije, ki potrjujejo pomembnost nečistot razen tuolena, skladnost materiala za ekotoksikološke preskuse s tehničnimi specifikacijami, pomembnost podtalničnega metabolita R42819 [7] in lastnosti flurokloridona, ki so zmožne povzročati endokrine motnje.
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 lahko pojavijo težave pri razlagi dolžnosti imetnikov obstoječih registracij v zvezi z dostopom do podatkov.
It is therefore appropriate to amend Decision 2008/934/EC accordingly.
Zato je primerno Odločbo 2008/934/EGS ustrezno spremeniti.
The line concerning flurochloridone in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica o flurokloridonu.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing flurochloridone 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 obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo flurokloridon kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to flurochloridone 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 izpolnjeni pogoji za flurokloridon iz Priloge I k navedeni direktivi, z izjemo tistih 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 v skladu s pogoji iz člena 13 navedene direktive.
By way of derogation from paragraph 1, for each authorised plant protection product containing flurochloridone 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 flurochloridone.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje flurokloridon 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, 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 flurokloridonu iz Priloge I k navedeni direktivi.
in the case of a product containing flurochloridone as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje flurokloridon kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo, ali
in the case of a product containing flurochloridone 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 flurokloridon kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 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 flurochloridone.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo flurokloridon.
[66 pp.]. doi:10.2903/j.efsa.2010.1869.
[66 str.]. doi:10.2903/j.efsa.2010.1869.
R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one.
R42819: (4RS)-4-(klorometil)-1-[3-(trifluorometil)fenil]pirolidin-2-on.
Flurochloridone
flurokloridon
CAS No: 61213-25-0
Št. CAS: 61213-25-0
CIPAC No: 430
Št. CIPAC: 430
Relevant impurities:
pomembne nečistote:
Toluene: max 8 g/kg
toluen: največ 8 g/kg
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu flurokloridona ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 4. februarja 2011.
In this overall assessment Member States shall pay particular attention to:
V celoviti oceni so države članice zlasti pozorne na:
the risk for non-target plants and aquatic organisms;
tveganje za neciljne rastline in vodne organizme;
the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
zaščito podtalnice, ko se aktivna snov uporablja na območjih z občutljivimi tlemi in/ali podnebnimi razmerami.
The Member States concerned shall ensure that the applicant submits to the Commission further confirmatory information as regards:
Zadevne države članice zagotovijo, da vlagatelj Komisiji predloži dodatne potrditvene informacije o:
the relevance of impurities other than toluene;
pomembnosti nečistot razen tuolena;
the compliance of ecotoxicological test material with the technical specifications;
skladnosti materiala za ekotoksikološke preskuse s tehničnimi specifikacijami;
the relevance of the groundwater metabolite R42819 (R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one);
pomembnosti podtalničnega metabolita R42819 (R42819: (4RS)-4-(klorometil)-1-[3-(trifluorometil)fenil]pirolidin-2-on );
the potential endocrine disrupting properties of flurochloridone.
lastnostih flurokloridona, ki so zmožne povzročati endokrine motnje.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011, the information set out in point (3) by 31 May 2013 and the information set out in point (4) within 2 years after the adoption of the OECD test guidelines on endocrine disruption.’
Zadevne države članice zagotovijo, da vlagatelj Komisiji predloži informacije iz točk (1) in (2) do 1. decembra 2011, informacije iz točke (3) do 31. maja 2013 ter informacije iz točke (4) v dveh letih po sprejetju smernic OECD za preizkušanje motenj endokrinega sistema.“