natgillin/translations-raw huggingface dataset:
Therefore, it is appropriate to require that the applicant submit further confirmatory information as regards: the specification of the technical material, as commercially manufactured, including appropriate analytical data, the relevance of the impurities, comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material, analytical methods for the monitoring of the metabolite M6 [7] in soil, groundwater and surface water and for the monitoring of metabolite M9 [8] in groundwater, additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 [9] and P/V-55 [10], rotational crop metabolism, the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals and the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council [11] as ‘suspected of causing cancer’.
Zato je primerno od vlagatelja zahtevati, da predloži dodatne potrditvene informacije o specifikacijah tehničnega materiala v tržni proizvodnji, vključno z ustreznimi analitskimi podatki, pomembnosti nečistoč, primerjavi in preveritvi preskusne snovi, ki se uporablja pri pripravi dokumentacije o toksičnosti za sesalce in okolje glede na specifikacije tehničnega materiala, analitskih metodah za spremljanje metabolita M6 [7] v tleh, podtalnici in površinskih vodah ter metabolita M9 [8] v podtalnici, dodatnih vrednostih o obdobju, ko v tleh razpade 50 % talnih metabolitov P-V/54 [9] in P/V-55 [10], presnovi v kulturah, ki sledijo v kolobarju, dolgotrajnem tveganju za semenojede ptice in sesalce ter rastlinojede sesalce, pomembnosti talnih metabolitov P-V/54, P/V-55 in M9 za podtalnico, če je karboksin v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta [11] razvrščen v „sum povzročitve raka“.
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 carboxin 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 karboksin, in zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice morajo veljavne registracije v skladu z določbami Direktive 91/414/EGS po potrebi spremeniti, nadomestiti ali preklicati.
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 [12] 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 [12], so pokazale, da se lahko pri razlagi obveznosti imetnikov veljavnih registracij glede dostopa do podatkov pojavijo težave.
The line concerning carboxin in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica o karboksinu.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing carboxin 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 karboksin kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to carboxin 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 karboksin 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 carboxin 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 carboxin.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje karboksin 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 karboksinu.
in the case of a product containing carboxin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje karboksin kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo ali,
in the case of a product containing carboxin 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 karboksin 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 carboxin.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo karboksin.
Carboxin
karboksin
CAS No: 5234-68-4
Št. CAS: 5234-68-4
CIPAC No: 273
Št. CIPAC: 273
Only uses as fungicide for seed treatment may be authorised.
Registrira se lahko samo kot fungicid za tretiranje semen.
Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.
Države članice zagotovijo, da registracije določajo, da se piliranje semena izvaja samo v profesionalnih objektih za tretiranje semen in da se v navedenih objektih uporabljajo najboljše razpoložljive tehnike, da se čim bolj zmanjša izpust prahu med skladiščenjem, prevozom in uporabo.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carboxin, 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 karboksina 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.
the risk to operators;
tveganje za izvajalce;
the risk to birds and mammals.
tveganje za ptice in sesalce.
the specification of the technical material, as commercially manufactured, including appropriate analytical data;
specifikacijah tehničnega materiala v tržni proizvodnji, vključno z ustreznimi analitskimi podatki;
comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;
primerjavi in preveritvi preskusne snovi, ki se uporablja pri pripravi dokumentacije o toksičnosti za sesalce in okolje glede na specifikacije tehničnega materiala;
analytical methods for the monitoring of the metabolite M6 [2] in soil, groundwater and surface water and for the monitoring of metabolite M9 [3] in groundwater;
analitskih metodah za spremljanje metabolita M6 [2] v tleh, podtalnici in površinskih vodah ter metabolita M9 [3] v podtalnici;
additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 [4] and P/V-55 [5];
dodatnih vrednostih o obdobju, ko v tleh razpade 50 % talnih metabolitov P-V/54 [4] in P/V-55 [5];
rotational crop metabolism;
presnovi v kulturah, ki sledijo v kolobarju;
the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals;
dolgotrajnem tveganju za semenojede ptice in sesalce ter rastlinojede sesalce;
the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 as “suspected of causing cancer”.
pomembnosti talnih metabolitov P-V/54, P/V-55 in M9 za podtalnico, če je karboksin v skladu z Uredbo (ES) št. 1272/2008 razvrščen v ‚sum povzročitve raka‘.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 1 December 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) within six months after the notification of the Decision classifying carboxin.’
Zadevne države članice zagotovijo, da vlagatelj predloži Komisiji informacije iz točk (a), (b) in (c) do 1. decembra 2011, informacije iz točk (d), (e), (f) in (g) do 31. maja 2013 ter informacije iz točke (h) v šestih mesecih po uradnem obvestilu o odločitvi glede razvrstitve karboksina.“
Decision 2008/934/EC provides for the non-inclusion of carboxin and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev karboksina in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning carboxin in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico o karboksinu.
Commission Implementing Directive 2011/53/EU
Izvedbena direktiva Komisije 2011/53/EU
amending Council Directive 91/414/EEC to include dazomet as active substance and amending Commission Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve dazometa kot aktivne snovi in spremembi Odločbe Komisije 2008/934/ES
That list included dazomet.
Navedeni seznam je vključeval dazomet.
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 dazomet.
Zato je bila za nevključitev dazometa 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 Belgium, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002.
Zahtevek je bil vložen pri Belgiji, ki je bila z Uredbo (ES) št. 1490/2002 imenovana za državo članico poročevalko.
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 dazomet to the Commission on 30 September 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 30. septembra 2010 Komisiji predložila svoj sklep o dazometu [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 dazomet.
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 dazometa.
It has appeared from the various examinations made that plant protection products containing dazomet 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 dazomet, 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 dazomet 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 dazomet 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 further information to confirm the potential groundwater contamination by methyl isothiocyanate, the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks, the acute risk to insectivorous birds and the long term risk to birds and mammals.
Zato je primerno zahtevati, da vlagatelj predloži dodatne informacije, ki potrjujejo potencialno onesnaženje podtalnice z metil izotiocianatom, oceno potencialnega prenosa metil izotiocianata znotraj atmosfere na dolge razdalje in s tem povezano okoljsko tveganje, akutno tveganje za žužkojede ptice in dolgoročno tveganje za ptice in sesalce.
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 dazomet 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 treba državam članicam omogočiti, da v šestih mesecih po vključitvi snovi pregledajo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo dazomat, in zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13, in ustreznih pogojev iz Priloge I. Države članice morajo veljavne registracije v skladu z določbami Direktive 91/414/EGS po potrebi spremeniti, nadomestiti ali preklicati.
The line concerning dazomet in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica o dazometu.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing dazomet 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 dazomet kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to dazomet 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 dazomet 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 dazomet 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 dazomet.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje dazomet 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 dazometu.
in the case of a product containing dazomet as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje dazomet kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo, ali
in the case of a product containing dazomet 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 dazomet 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 dazomet.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo dazomet.
[91 pp.]. doi:10.2903/j.efsa.2010.1833.
[91 str.]. doi:10.2903/j.efsa.2010.1833.
CAS No: 533-74-4
št. CAS: 533-74-4
CIPAC No: 146
št. CIPAC: 146
Only uses as nematicide, fungicide, herbicide and insecticide may be authorised.
Registrira se lahko samo kot nematocid, fungicid, herbicid in insekticid.
Only application as soil fumigant may be authorised.
Registrira se lahko samo kot talni fumigant.
Use shall be limited to one application every third year.
Uporaba je omejena na enkrat vsake tri leta.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dazomet, 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 poročila o pregledu dazometa ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 11. marca 2011.
the risk to operators, workers and bystanders;
tveganje za izvajalce, delavce in druge navzoče osebe;
the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;
zaščito podtalnice, kadar se aktivna snov uporablja na območjih z občutljivo zemljo in/ali podnebnimi razmerami;
Conditions of use shall include risk mitigation measures, where appropriate.
Pogoji za registracijo po potrebi vključujejo ukrepe za zmanjšanje tveganja.
the potential groundwater contamination by methyl isothiocyanate;
potencialnem onesnaženju podtalnice z metil izotiocianatom;
the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks;
oceni potencialnega prenosa metil izotiocianata znotraj atmosfere na dolge razdalje in s tem povezanim okoljskim tveganjem;
the acute risk to insectivorous birds;
akutnem tveganju za žužkojede ptice;
the long term risk to birds and mammals.
dolgoročnem tveganju za ptice in sesalce.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.’
Zadevne države članice zagotovijo, da vlagatelj Komisiji predloži informacije iz točk (a), (b), (c) in (d) do 31. maja 2013.“
Decision 2008/934/EC provides for the non-inclusion of dazomet and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev dazometa in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning dazomet in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico o dazometu.
Commission Implementing Directive 2011/54/EU
Izvedbena direktiva Komisije 2011/54/EU
amending Council Directive 91/414/EEC to include metaldehyde as active substance and amending Commission Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve metaldehida kot aktivne snovi in spremembi Odločbe Komisije 2008/934/ES
That list included metaldehyde.
Navedeni seznam je vključeval metaldehid.
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 metaldehyde.
Zato je bila za nevključitev metaldehida 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].