natgillin/translations-raw huggingface dataset:
The review of daminozide revealed a number of open questions which were addressed by the EFSA.
Pregled za daminozid je razkril številna nerešena vprašanja, ki jih je nato obravnavala EFSA.
The Scientific Panel on Plant Health, Plant Protection Products and their Residues (PPR Panel) of the EFSA was asked to comment on the mechanism of action of the carcinogenic response of rodents to 1,1-dimethylhydrazide (UDMH) and to indicate whether or not a threshold could be derived for this effect.
Znanstveni odbor za zdravstveno varstvo rastlin, fitofarmacevtska sredstva in njihove ostanke pri EFSA (odbor) je bil zaprošen, da poda pripombe na mehanizem delovanja karcinogenega odziva glodalcev na 1,1-dimetilhidrazid (UDMH) in da navede, ali je za ta učinek mogoče določiti mejno vrednost.
If yes, it was requested to indicate this value.
Če bi bilo to mogoče, je bil zaprošen za navedbo te vrednosti.
The PPR Panel, having regard to the submitted questions, concluded [4] that, on the basis of the available data, it is not possible to identify the mechanism responsible for the carcinogenic action of UDMH in rodents.
Odbor je ob upoštevanju predloženih vprašanj sklenil [4], da na podlagi razpoložljivih podatkov ni mogoče opredeliti mehanizma, odgovornega za rakotvorno delovanje UDMH pri glodalcih.
There is no in vitro evidence of genotoxicity of pure and oxidation-protected UDMH and in vivo studies are not available.
V in vitro študijah ni dokazov za genotoksičnost pri čistem in pred oksidacijo zaščitenem UDMH, študij in vivo pa ni na voljo.
In addition, the PPR Panel noted an apparent discrepancy in that daminozide long-term studies did not give rise to carcinogenicity in rats and mice at doses that should have produced internal doses of metabolically-formed UDMH at least one order of magnitude higher than those proven to be effective on direct testing.
Poleg tega je odbor ugotovil očitno neskladje med tem, da dolgoročne študije daminozida niso sprožile rakotvornosti pri podganah in miših pri odmerkih, ki bi morali povečati nastanek metabolnega UDMH vsaj za en red velikosti nad odmerki, ki so se izkazali za delujoče pri neposrednih testih.
In addition, methylation of N7 guanine was found to be 50-fold higher in one study following oral administration of UDMH to rats, when compared to the corresponding data for daminozide.
Poleg tega je bila v eni študiji ugotovljena vsaj 50-krat višja metilacija gvanina N7 pri oralnem vnosu UDMH pri podganah v primerjavi z ustreznimi podatki za daminozid.
Thus, the PPR Panel considered that any conclusion on the mechanism of carcinogenicity of orally administered UDMH should be regarded to include a degree of uncertainty.
Zato je odbor menil, da je treba pri vsakem sklepu glede mehanizma rakotvornosti zaužitega UDMH upoštevati določeno raven negotovosti.
The PPR Panel concluded that the weight of evidence is against a genotoxic mechanism.
Odbor je sklenil, da dokazi govorijo proti genotoksičnemu mehanizmu
Among possible non-genotoxic mechanisms, altered regulation of cell proliferation or hormonal imbalance are plausible alternatives to genotoxicity, but these mechanisms have not been specifically investigated and thus a more definitive conclusion on the mechanism involved is not possible at the moment.
Med možnimi ne-genotoksičnimi mehanizmi je verjeten pojav spremenjene regulacije celičnih delitev ali hormonsko neravnovesje, vendar ti mehanizmi niso posebej raziskani, zato trenutno ni mogoče z večjo gotovostjo sklepati o zadevnem mehanizmu.
In experimental testing of UDMH for carcinogenicity in rats and mice, no effects were observed at 0,09 mg/kg bw/day and 1,41 mg/kg bw/day, respectively.
Poskusna testiranja UDMH na rakotvornost pri podganah in miših pri odmerkih 0,09 mg/kg tt/dan in 1,41 mg/kg tt/dan, v tem zaporedju, niso pokazala nobenih učinkov.
If the observed UDMH carcinogenicity is due to a non-genotoxic mechanism, the above indicated doses should be considered to be toxicological thresholds.
Če je opažena rakotvornost UDMH posledica mehanizma, ki ni genotoksičen, je treba zgoraj navedene odmerke obravnavati kot toksikološke mejne vrednosti.
However, taking together the uncertainties associated with the mechanism and the possibility that UDMH in greenhouse conditions may form oxidised derivatives that might be genotoxic, the PPR Panel is of the opinion that any use of these doses as thresholds should be undertaken only with due caution.
Vendar je treba po mnenju odbora ob upoštevanju negotovosti v zvezi z mehanizmom in možnostmi, da se lahko pri uporabi UDMH v rastlinjakih tvorijo oksidirane oblike, ki so lahko genotoksične, uporabo teh odmerkov kot mejnih vrednosti obravnavati s previdnostjo.
The opinion was taken into consideration by the Standing Committee that concluded that the use of daminozide is acceptable under the specified conditions.
Mnenje je preučil Stalni odbor in sklenil, da je uporaba daminozida sprejemljiva pod določenimi pogoji.
The review of thiophanate-methyl revealed a number of open questions which were addressed by the Scientific Committee on Plants.
Pregled za tiofanat-metil je razkril številna nerešena vprašanja, ki jih je nato obravnaval Znanstveni odbor za rastline.
The Scientific Committee was asked to comment on the advisability of establishing an acceptable daily intake (ADI) and acceptable operator exposure level (AOEL) having regard particularly to the results of mutagenicity, carcinogenicity and reproductive studies for benomyl, carbendazim and thiophanate-methyl.
Znanstveni odbor je bila zaprošen, da poda pripombe glede priporočljivosti določitve sprejemljivega dnevnega vnosa (ADI) in sprejemljive ravni izpostavljenosti delavca (AOEL) zlasti ob upoštevanju rezultatov mutagenosti, rakotvornosti in reproduktivnih študij za benomil, karbendazim in tiofanat-metil.
The Committee [5] noted that carbendazim is the biologically active substance common to these three substances.
Odbor [5] je ugotovil, da je karbendazim biološko aktivna snov, skupna tem trem snovem.
Benomyl in particular, but also thiophanate-methyl, is metabolised to carbendazim and all three substances produce numerical chromosomal aberrations (aneuploidy) in mammalian cells, exposed in vivo.
Zlasti benomil, ampak tudi tiofanat-metil, se presnavljata v karbendazim in vse tri snovi povzročajo številne kromosomske anomalije (aneuploidija) v celicah sesalcev, izpostavljenih in vivo.
There is no evidence that any other form of damage to genetic material is induced by any of these substances.
Ni dokazov, da bi katera od teh snovi še kakor koli drugače škodila genskemu materialu.
Carcinogenicity is not a concern.
Rakotvornost ni zaskrbljujoča.
The known effects of these fungicides upon reproduction are explicable by interaction with the microtubules of the spindle apparatus.
Znane učinke teh fungicidov na reprodukcijo je mogoče razložiti z vplivom na mikrotubule delitvenega vretena.
The mechanism of aneuploidy induction is well understood and consists of inhibition of polymerisation of tubulin, the protein that is essential for the segregation of chromosomes during cell division: it does not involve any interaction with DNA.
Mehanizem indukcije aneuploidije je dobro znan in sestoji iz inhibicije polimerizacije tubulina, proteina, ki je nujen za ločevanje kromosomov pri celičnih delitvah: to ne vključuje nikakršne interakcije z DNK.
Since multiple copies of tubulin molecules are present in proliferating cells, in the presence of low concentration of the fungicides a limited number of tubulin molecules will be affected and consequently no toxicological adverse effects will ensue.
Ker so pri delitvi celic prisotne večkratne kopije tubulinskih molekul, bo prisotnost nizkih koncentracij fungicidov vplivala na omejeno število tubulinskih molekul in to ne bo imelo nikakršnega toksikološkega škodljivega učinka.
Consequently, a clear no adverse effect level is recognisable and both an ADI and an AOEL can be established.
Zato ni opaziti nikakršnega škodljivega učinka in lahko se določi tako ADI kot AOEL.
It has appeared from the various examinations made that plant protection products containing chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl 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.
Kot so pokazale različne raziskave, se za fitofarmacevtska sredstva, ki vsebujejo klorotalonil, klorotoluron, cipermetrin, daminozid in tiofanat-metil, lahko predvideva, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti glede uporab, ki so bile obravnavane in podrobno opisane v poročilu Komisije o pregledu.
It is therefore appropriate to include this active substance 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 to aktivno snov v Prilogo I, da se zagotovi, da se v vseh državah članicah izda dovoljenje v skladu z določili navedene direktive za fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
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 predvidi primeren rok, v katerem se lahko države članice in zainteresirane strani pripravijo na izpolnjevanje novih zahtev, ki so posledica vključitve.
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 zagotoviti daljše obdobje za predložitev in oceno celotne dokumentacije iz Priloge III za vsako fitofarmacevtsko sredstvo za vse predvidene uporabe v skladu z enotnimi načeli, določenimi v Direktivi 91/414/EGS.
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 iz preteklih vključitev aktivnih snovi, ocenjenih v okviru Uredbe (EGS) št. 3600/92, v Prilogo I k Direktivi 91/414/EGS, kažejo, da lahko pri tolmačenju dolžnosti imetnikov obstoječih dovoljenj nastopijo težave 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.
Da bi se izognili nadaljnjim težavam, se zato zdi primerno, da se razjasnijo dolžnosti držav članic, zlasti dolžnost preverjanja, da ima imetnik registracije dostop do dokumentacije, ki izpolnjuje zahteve 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 v primerjavi z direktivami o spremembah Priloge I, sprejetimi do zdaj, državam članicam ali imetnikom registracij ne nalaga nobenih dodatnih obveznosti.
It is therefore appropriate to amend Directive 91/414/EEC accordingly.
Zato je treba ustrezno spremeniti Direktivo 91/414/EGS.
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Priloga I k Direktivi 91/414/EGS se spremeni, kakor je določeno v Prilogi k tej direktivi.
Member States shall adopt and publish by 31 August 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. avgusta 2006.
They shall apply those provisions from 1 September 2006.
Države članice uporabljajo te predpise od 1. septembra 2006.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as active substances by 31 August 2006.
Države članice v skladu z Direktivo 91/414/EGS do 31. avgusta 2006 po potrebi spremenijo ali prekličejo obstoječe registracije za fitofarmacevtska sredstva, ki vsebujejo klorotalonil, klorotoluron, cipermetrin, daminozid ali tiofanat-metil kot aktivne snovi.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl are met, with the exception of those identified in part B of the entries concerning those active substances, 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 tega datuma zlasti potrdijo, da so izpolnjeni pogoji iz Priloge I k navedeni direktivi, ki se nanašajo na klorotalonil, klorotoluron, cipermetrin, daminozid in tiofanat-metil, z izjemo tistih iz dela B vpisov, ki se nanašajo na navedene aktivne snovi, in da ima imetnik dovoljenja v skladu s pogoji člena 13 navedene direktive dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi.
By derogation from paragraph 1, for each authorised plant protection product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl 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 28 February 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 entries in Annex I to that Directive concerning chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl.
Z odstopanjem od odstavka 1 države članice za vsako dovoljeno fitofarmacevtsko sredstvo, ki vsebuje klorotalonil, klorotoluron, cipermetrin, daminozid ali tiofanat-metil, bodisi kot edino aktivno snov bodisi kot eno od več aktivnih snovi, ki se navedejo v Prilogi I k Direktivi 91/414/EGS najpozneje do 28. februarja 2006, ponovno ocenijo sredstvo 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 vpisov v Prilogi I k navedeni direktivi o klorotalonilu, klorotoluronu, cipermetrinu, daminozidu in tiofanat-metilu.
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 te ocene ugotovijo, ali sredstvo izpolnjuje pogoje iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414/EGS.
Following that determination Member States shall:
Po tej ugotovitvi države članice:
in the case of a product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2010 at the latest; or
pri sredstvih, ki vsebujejo klorotalonil, klorotoluron, cipermetrin, daminozid ali tiofanat-metil kot edino aktivno snov, po potrebi spremenijo ali prekličejo dovoljenje najpozneje do 28. februarja 2010; ali
in the case of a product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 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.
pri sredstvih, ki vsebujejo klorotalonil, klorotoluron, cipermetrin, daminozid ali tiofanat-metil kot eno od več aktivnih snovi, po potrebi spremenijo ali prekličejo dovoljenje do 28. februarja 2010 ali do datuma, določenega za tako spremembo ali preklic v ustrezni(-h) direktivi(-ah), s katero(-imi) je(so) bila(-e) ustrezna(-e) snov(-i) dodana(-e) Prilogi I k Direktivi 91/414/EGS; upošteva se datum, ki je poznejši.
This Directive shall enter into force on 1 March 2006.
Ta direktiva začne veljati 1. marca 2006.
Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a request from the Commission related to the evaluation of daminozide in the context of Council Directive 91/414/EEC (The EFSA Journal (2004), 61, 1-27), adopted on 11 May 2004.
Mnenje Znanstvenega odbora za zdravstveno varstvo rastlin, fitofarmacevtska sredstva in njihove ostanke na zahtevo Komisije glede ocene daminozida v smislu Direktive Sveta 91/414/EGS (The EFSA Journal (2004), št. 61, str. 1–27), sprejeto 11. maja 2004.
Opinion of the Scientific Committee on Plants (SCP/BENOMY/002 — final, SCP/CARBEN/002 — final, SCP/THIOPHAN/002 — final) of 23 March 2001 regarding the evaluation of benomyl, carbendazim and thiophanate-methyl in the context of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Opinion adopted by the Scientific Committee on Plants on 7 March 2001).
Mnenje Znanstvenega odbora za rastline (SCP/BENOMY/002–konč., SCP/CARBEN/002–konč., SCP/THIOPHAN/002–konč.) z dne 23. marca 2001 o oceni benomila, karbendazina in tiofanat-metila v smislu Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet (mnenje, ki ga je Znanstveni odbor za rastline sprejel 7. marca 2001).
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:
Expiration of inclusion
Veljavnost registracije
CAS No 1897-45-6
Št. CAS 1897-45-6
CIPAC No 288
Št. CIPAC 288
Tetrachloroisophthalonitrile
Tetrakloroizoftalonitril
Hexachlorobenzene: not more than 0,01 g/kg
heksaklorobenzen: največ 0,01 g/kg
Decachlorobiphenyl: not more than 0,03 g/kg
dekaklorobifenil: največ 0,03 g/kg
Only uses as fungicide may be authorised
Registrira se lahko samo kot fungicid.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepne ugotovitve poročila o pregledu za klorotalonil, in zlasti dodatka I in II k poročilu, kakor sta bila dokončno oblikovana na Stalnem odboru za prehransko verigo in zdravje živali 15. februarja 2005.
In this overall assessment Members States must pay particular attention to the protection of:
V tej celoviti oceni morajo države članice posebno pozornost posvetiti varstvu:
aquatic organisms,
vodnih organizmov,
groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions
podtalnice, zlasti glede na aktivno snov in njena metabolita R417888 in R611965 (SDS46851), ko se snov uporablja na območjih z občutljivimi tlemi in/ali podnebnimi razmerami.
Conditions of use should include risk mitigation measures, where appropriate
Pogoji uporabe po potrebi vključujejo ukrepe za zmanjšanje tveganja.
Chlorotoluron (unstated stereochemistry)
Klorotoluron (stereokemija ni navedena)
CAS No 15545-48-9
Št. CAS 15545-48-9
CIPAC No 217
Št. CIPAC 217
3-(3-chloro-p-tolyl)-1,1-dimethylurea
3-(3-kloro-p-tolil)-1,1-dimetilsečnina
Only uses as herbicide may be authorised
Registrira se lahko samo kot herbicid.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepne ugotovitve poročila o pregledu za klorotoluron, in zlasti dodatka I in II k poročilu, kakor sta bila dokončno oblikovana na Stalnem odboru za prehransko verigo in zdravje živali 15. februarja 2005.
In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions.
V tej celoviti oceni morajo države članice posebno pozornost posvetiti varstvu podtalnice, ko se snov uporablja na območjih z občutljivimi tlemi in/ali podnebnimi razmerami.
Conditions of authorisation should include risk mitigation measures, where appropriate
Pogoji za izdajo dovoljenja po potrebi vključujejo ukrepe za zmanjšanje tveganja.
CAS No 52315-07-8
Št. CAS 52315-07-8
CIPAC No 332
Št. CIPAC 332
(RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
(RS)-α-ciano-3 fenoksibenzil-(1RS)-cis, trans-3-(2,2-diklorovinil)-2,2-dimetilciklopropan karboksilat
(4 isomer pairs: cis-1, cis-2, trans-3, trans-4)
(4 pari izomerov: cis-1, cis-2, trans-3, trans-4)
Only uses as insecticide may be authorised
Registrira se lahko samo kot insekticid.
Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods.
morajo države članice posebno pozornost posvetiti varstvu vodnih organizmov, čebel in neciljnih členonožcev.
Conditions of authorisation should include risk mitigation measures, where appropriate,
Pogoji za izdajo dovoljenja po potrebi vključujejo ukrepe za zmanjšanje tveganja,
Member States must pay particular attention to the operator safety.
morajo države članice posebno pozornost posvetiti varstvu pri delu.
Conditions of authorisation should include protective measures, where appropriate
Pogoji za izdajo dovoljenja po potrebi vključujejo ukrepe za varstvo pri delu.
CAS No 1596-84-5
Št. CAS 1596-84-5
CIPAC No 330
Št. CIPAC 330
N-dimethylaminosuccinamic acid
N-dimetilaminosukcinamilna kislina
Impurities:
Nečistoče:
N-nitrosodimethylamine: not more than 2,0 mg/kg
n-nitrosodimetilamin: največ 2,0 mg/kg
1,1-dimethylhydrazide: not more than 30 mg/kg
1,1-dimetilhidrazid: največ 30 mg/kg
Only uses as growth regulator in non-edible crops may be authorised
Registrira se lahko samo kot regulator rasti za posevke, ki niso namenjeni prehrani.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepne ugotovitve poročila o pregledu za daminozid, in zlasti dodatka I in II k poročilu, kakor sta bila dokončno oblikovana na Stalnem odboru za prehransko verigo in zdravje živali 15. februarja 2005.
In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry.
V tej celoviti oceni morajo države članice posebno pozornost posvetiti varstvu pri delu in zaščiti delavcev pri vstopu na tretirano območje.
Thiophanate-methyl (unstated stereochemistry)
Tiofanat-metil (stereokemija ni navedena)
CAS No 23564-05-8
Št. CAS 23564-05-8
CIPAC No 262
Št. CIPAC 262
Dimethyl 4,4’-(o-phenylene)bis(3-thioallophanate)
Dimetil 4,4′-(o-fenilen)bis(3-tioalofanat)