natgillin/translations-raw huggingface dataset:
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [1] and in particular Article 6(1) thereof,
ob upoštevanju Direktive Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [1], in zlasti člena 6(1) Direktive,
That list includes warfarin.
Ta seznam vključuje varfarin.
For warfarin the effects on human health and the environment has been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers.
Vpliv varfarina na zdravje ljudi in na okolje se je presojal v skladu z določbami Uredbe (EGS) št. 3600/92 za vrste uporabe, ki so jih predlagali prijavitelji.
By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92 [3], Ireland was designated as Rapporteur Member State.
Z Uredbo Komisije (ES) št. 933/94 z dne 27. aprila 1994 o določitvi aktivnih snovi fitofarmacevtskih sredstev in imenovanju držav članic poročevalk za izvajanje Uredbe Komisije (EGS) št. 3600/92 [3] je bila Irska imenovana za državo članico poročevalko.
Ireland submitted the relevant assessment report and recommendations to the Commission on 8 May 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.
Irska je 8. maja 1996 Komisiji predložila ustrezno poročilo o oceni in priporočila v skladu s členom 7(1)(c) Uredbe (EGS) št. 3600/92.
The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.
Poročilo o oceni so države članice in Komisija pregledale v Stalnem odboru za prehranjevalno verigo in zdravje živali.
The review was finalised on 23 September 2005 in the format of the Commission review report for warfarin.
Pregled poročila je bil končan 23. septembra 2005 s poročilom o pregledu Komisije za varfarin.
The report on warfarin and further information were also submitted to the Scientific Committee for Plants.
Poročilo o varfarinu in dodatne informacije so bili predloženi tudi Znanstvenemu odboru za rastline.
The Committee was asked to comment on the acceptability of using clinical data generated following repeated warfarin use as an anti-coagulant in human medicine for establishing an acceptable daily intake (ADI) and an acceptable operator exposure level (AOEL).
Odbor je bil zaprošen za mnenje o dopustnosti uporabe kliničnih podatkov, zbranih med ponavljajočo uporabo varfarina kot antikoagulanta v zdravstvu, za določitev sprejemljivega dnevnega vnosa (SDV) in sprejemljive ravni izpostavljenosti delavca (SRID).
In its opinion [4], the Scientific Committee concluded that it is not necessary to allocate an ADI for warfarin.
Znanstveni odbor je v svojem mnenju [4] sklenil, da za varfarin ni treba določiti SDV.
Furthermore, data available from the extensive clinical use of warfarin as an anticoagulant may confidently be expected to support the establishment of an ADI, should this be considered necessary.
Poleg tega bo razširjena klinična uporaba varfarina kot antikoagulanta verjetno privedla do določitve SDV, če bo to potrebno.
An AOEL can likewise be established based on human data, taking into account that in rats about 15 % of the applied dose is absorbed through the skin.
SRID je prav tako lahko določena na podlagi podatkov za ljudi, ob upoštevanju, da se pri podganah 15 % uporabljenega odmerka absorbira čez kožo.
It has appeared from the various examinations made, that plant protection products containing warfarin 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 were examined and detailed in the Commission review report.
Različna preverjanja so pokazala, da je za fitofarmacevtska sredstva, ki vsebujejo varfarin, pričakovati, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include warfarin in Annex I, in order to ensure that in all Member States authorisation of plant protection products containing warfarin can be granted in accordance with the provisions of that Directive.
Zato je primerno varfarin vključiti v Prilogo I, da se zagotovi, da se v vseh državah članicah registracije fitofarmacevtskih sredstev, ki vsebujejo varfarin, lahko odobrijo v skladu z določbami navedene direktive.
Warfarin is used as a rodenticide.
Varfarin se uporablja kot sredstvo za uničevanje miši in podgan.
All other active substances used as rodenticides are covered by Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [5].
Vse druge aktivne snovi, ki so uporabljene kot sredstvo za uničevanje miši in podgan, pokriva Uredba Komisije (ES) št. 1112/2002 z dne 20. junija 2002 o podrobnih pravilih za izvajanje četrte faze delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS [5].
Furthermore, the substance is currently subject to evaluation in the framework of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [6].
Poleg tega se snov trenutno ocenjuje v okviru Direktive Evropskega parlamenta in Sveta 98/8/ES z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [6].
As with all substances included in Annex I to Directive 91/414/EEC, the status of warfarin could be reviewed under Article 5(5) of that Directive in the light of any new data becoming available, in particular from the assessment of similar substances or from the assessment of warfarin itself under Directive 98/8/EC.
Kot v primeru ostalih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS, se status varfarina v skladu s členom 5(5) navedene direktive lahko naknadno spremeni na podlagi novih razpoložljivih podatkov, zlasti ocene podobnih snovi ali ocene varfarina v skladu z Direktivo 98/8/ES.
The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje, pridobljene s prejšnjimi vključitvami aktivnih snovi, ocenjenih v okviru Uredbe (EGS) št. 3600/92, v Prilogo I k Direktivi 91/414/EGS, so pokazale, da lahko pride do težav pri razlagi dolžnosti imetnikov obstoječih registracij v zvezi z dostopom do podatkov.
In order to avoid further difficulties, it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive.
V izogib nadaljnjim težavam se zato zdi nujno razjasniti dolžnosti držav članic, zlasti dolžnost, da preverijo, ali imetnik dovoljenja dokazuje dostop do dokumentacije, ki izpolnjuje pogoje Priloge II k navedeni direktivi.
However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.
Vendar pa ta razjasnitev državam članicam ali imetnikom registracij ne nalaga nikakršnih novih obveznosti glede na direktive, ki so bile do sedaj sprejete o spremembi Priloge I.
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
Pred vključitvijo aktivne snovi v Prilogo I se določi razumen rok, v katerem se države članice in zainteresirane strani lahko pripravijo na izpolnjevanje novih zahtev, ki izhajajo iz vključitve.
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 warfarin 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, opredeljene v Direktivi 91/414/EGS kot posledica vključitve aktivne snovi v Prilogo I, je treba državam članicam dovoliti, da v roku šestih mesecev po vključitvi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo varfarin, da se zagotovi izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice spremenijo, zamenjajo ali prekličejo, če je primerno, obstoječe registracije v skladu z določbami Direktive 91/414/EGS.
By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
Z odstopanjem od zgornjega roka je treba predvideti daljše obdobje za predložitev in oceno celotne dokumentacije iz Priloge III za vsako fitofarmacevtsko sredstvo za vsako nameravano uporabo v skladu z enotnimi načeli iz Direktive 91/414/EGS.
It is therefore appropriate to amend Directive 91/414/EEC accordingly.
Zato je primerno Direktivo 91/414/EGS ustrezno spremeniti.
Member States shall adopt and publish by 31 March 2007, at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 31. marca 2007 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Komisiji nemudoma sporočijo besedila teh predpisov in primerjalno tabelo med temi predpisi in to direktivo.
They shall apply those provisions from 1 April 2007.
Te predpise uporabljajo od 1. aprila 2007.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing warfarin as an active substance by 31 March 2007.
Države članice do 31. marca 2007 v skladu z Direktivo 91/414/EGS spremenijo ali umaknejo, kjer je potrebno, obstoječe registracije za fitofarmacevtska sredstva, ki vsebujejo varfarin kot aktivno snov.
By that date, they shall in particular verify that the conditions in Annex I to that Directive, relating to warfarin, 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.
Do tega datuma zlasti preverijo, da so izpolnjeni pogoji v zvezi z varfarinom iz Priloge I k navedeni direktivi, z izjemo tistih, ki so opredeljeni v delu B uvrstitve navedene aktivne snovi, in da ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi v skladu s pogoji iz člena 13.
By derogation from paragraph 1, for each authorised plant protection product containing warfarin 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 September 2006 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 warfarin.
Z odstopanjem od odstavka 1 države članice najpozneje do 30. septembra 2006 ponovno ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje varfarin, bodisi kot edino aktivno snov bodisi kot eno od več aktivnih snovi, ki so navedene v Prilogi I k Direktivi 91/414/EGS, in sicer v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414/EGS in na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k navedeni direktivi ter ob upoštevanju dela B uvrstitve v Prilogi I k Direktivi v zvezi z varfarinom.
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 določijo, ali sredstvo izpolnjuje pogoje iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414/EGS.
in the case of a product containing warfarin as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2010 at the latest; or
če sredstvo vsebuje varfarin kot edino aktivno snov, registracijo po potrebi spremenijo ali umaknejo najpozneje do 30. septembra 2010; ali
in the case of a product containing warfarin as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2010 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 fitofarmacevtsko sredstvo vsebuje varfarin kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali umaknejo najpozneje do 30. septembra 2010 ali do datuma, določenega za tako spremembo ali umik v ustrezni direktivi ali direktivah, s katerimi je bila zadevna snov ali snovi dodane v Prilogo I k Direktivi 91/414/EGS, glede na to, katera je bila zadnja.
This Directive shall enter into force on 1 October 2006.
Ta direktiva začne veljati 1. oktobra 2006.
Done at Brussels, 17 January 2006.
V Bruslju, 17. januarja 2006
Opinion of the Scientific Committee on Plants regarding the possible inclusion of warfarin in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market; SCP/WARFAR/002 final, adopted on 6 June 2000.
Mnenje Znanstvenega odbora za rastline o možni vključitvi varfarina v Prilogo I k Direktivi Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet; SCP/WARFAR/002 konč., sprejeta 6. junija 2000.
The following entries shall be added at the end of the table in Annex I to Directive 91/414/EEC
Naslednji vpisi se dodajo na konec tabele v Prilogi I k Direktivi 91/414/EGS
CAS No 81-81-2
Št. CAS 81-81-2
CIPAC No 70
Št. CIPAC 70
(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin
(RS)-4-hidroksi-3-(3-okso-1-funilbutil)kumarin 3-(acetonil-benzil)-4-hidroksikumarin
1 October 2006
oktober 2006
Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.
Dovoljena je samo uporaba kot sredstvo za uničevanje miši in podgan v obliki naprej pripravljenih vab, ki se jih po potrebi namesti v posebej izdelane lijake.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepne ugotovitve poročila o pregledu za varfarin in zlasti dodatkov I in II, kot so bili dokončno oblikovani v Stalnem odboru za prehranjevalno verigo in zdravje živali 23. septembra 2005.
In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.
V tej celoviti oceni morajo biti države članice posebno pozorne na varovanje uporabnikov, ptic in neciljnih sesalcev.
Commission Directive 2006/6/EC
Direktiva Komisije 2006/6/ES
amending Council Directive 91/414/EEC to include tolylfluanid as active substance
o spremembi Direktive Sveta 91/414/EGS glede vključitve tolilfluanida kot aktivne snovi
Commission Regulations (EC) No 451/2000 [2] and (EC) No 703/2001 [3] lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC.
Uredbi Komisije (ES) št. 451/2000 [2] in (ES) št. 703/2001 [3] določata podrobna pravila za izvajanje druge faze delovnega programa iz člena 8(2) Direktive 91/414/EGS in določata seznam aktivnih snovi, ki jih je treba oceniti zaradi njihove možne vključitve v Prilogo I k Direktivi 91/414/EGS.
That list includes tolylfluanid.
Ta seznam vključuje tolilfluanid.
For tolylfluanid the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifiers.
Vplivi tolilfluanida na zdravje ljudi in okolje so bili ocenjeni v skladu z določbami uredb (ES) št. 451/2000 in (ES) št. 703/2001 za vrste uporabe, ki jih je predlagal prijavitelj.
Moreover, those regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000.
Poleg tega navedeni uredbi določata države članice poročevalke, ki morajo Evropski agenciji za varnost hrane (EFSA) v skladu s členom 8(1) Uredbe (ES) št. 451/2000 predložiti ustrezna poročila o oceni in priporočila.
For tolylfluanid the rapporteur Member State was Finland and all relevant information was submitted on 13 June 2003.
Država članica poročevalka za tolilfluanid je bila Finska, vse ustrezne informacije pa so bile predložene 13. junija 2003.
The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 14 March 2005 in the format of the EFSA Scientific Report for tolylfluanid [4].
Poročilo o oceni so v okviru delovne skupine za ovrednotenje pregledali strokovnjaki držav članic in EFSA in ga 14. marca 2005 predstavili Komisiji v obliki znanstvenega poročila EFSA o tolilfluanidu [4].
This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 September 2005 in the format of the Commission review report for tolylfluanid.
To poročilo so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter ga dokončno oblikovale 23. septembra 2005 v obliki poročila Komisije o pregledu glede tolilfluanida.
It has appeared from the various examinations made that plant protection products containing tolylfluanid 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 were examined and detailed in the Commission review report.
Različne preiskave so pokazale, da je za fitofarmacevtska sredstva, ki vsebujejo tolilfluanid, pričakovati, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include tolylfluanid 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 tolilfluanid v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive odobri registracija fitofarmacevtskih sredstev, ki vsebujejo to aktivno snov.
Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points.
Brez poseganja v navedeni sklep je primerno pridobiti nadaljnje podatke o določenih posameznih točkah.
Therefore it is appropriate to require that tolylfluanid should be subjected to further testing for confirmation of the long term risk assessment for herbivorous mammals and that such studies should be presented by the notifier.
Zato je primerno zahtevati, da se za tolilfluanid opravijo nadaljnji testi za potrditev ocene dolgoročnega tveganja za rastlinojede sesalce in da takšne študije predloži prijavitelj.
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 tolylfluanid 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, opredeljene v Direktivi 91/414/EGS kot posledica vključitve aktivne snovi v Prilogo I, je državam članicam treba dovoliti, da v roku šestih mesecev po vključitvi snovi pregledajo obstoječe registracije za fitofarmacevtska sredstva, ki vsebujejo tolilfluanid, da se zagotovi izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 Direktive in ustreznih pogojev iz Priloge I. Po potrebi države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije 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 [5] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje, pridobljene pri prejšnjih vključitvah aktivnih snovi, ocenjenih v okviru Uredbe Komisije (EGS) št. 3600/92 [5], v Prilogo I k Direktivi 91/414/EGS, so pokazale, da lahko pride do težav pri razlaganju dolžnosti imetnikov obstoječih registracij v zvezi z dostopom do podatkov.
In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive.
V izogib nadaljnjim težavam se zato zdi nujno razjasniti dolžnosti držav članic, zlasti dolžnost, da preverijo, če imetnik registracije lahko dokaže dostop do dokumentacije, ki izpolnjuje pogoje iz Priloge II k navedeni direktivi.
However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.
Vendar ta razjasnitev državam članicam ali imetnikom registracij ne nalaga nikakršnih novih obveznosti v primerjavi z direktivami o spremembah Priloge I, ki so bile sprejete do zdaj.
Member States shall adopt and publish by 31 March 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 31. marca 2007 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Komisiji takoj posredujejo besedila navedenih predpisov ter primerjalno tabelo med navedenimi predpisi in to direktivo.