natgillin/translations-raw huggingface dataset:
The application was submitted to the United Kingdom, which had been designated rapporteur Member State by Regulation (EC) No 451/2000.
Zahtevek je bil predložen Združenemu kraljestvu, ki je bilo z Uredbo (ES) št. 451/2000 imenovano za državo poročevalko.
The time period for the accelerated procedure was respected.
Rok za pospešeni postopek je bil upoštevan.
The specification of the active substance and the supported uses are the same as were the subject of Decision 2007/628/EC.
Specifikacija aktivne snovi in predvidene uporabe so enake, kot so bile v Odločbi 2007/628/ES.
That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
Navedeni zahtevek izpolnjuje tudi preostale vsebinske in postopkovne zahteve iz člena 15 Uredbe (ES) št. 33/2008.
The United Kingdom evaluated the new information and data submitted by the notifier and prepared an additional report on 15 May 2008.
Združeno kraljestvo je ocenilo nove informacije in podatke, ki jih je predložil predlagatelj, in 15. maja 2008 pripravilo dodatno poročilo.
The additional report was peer reviewed by the Member States and the EFSA and presented to the Commission on 19 December 2008 in the format of the EFSA Scientific Report for methomyl [6].
Dodatno poročilo so pregledali strokovnjaki držav članic in EFSA ter ga 19. decembra 2008 predstavili Komisiji v obliki znanstvenega poročila EFSA o metomilu [6].
This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 12 June 2009 in the format of the Commission review report for methomyl.
To poročilo so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter 12. junija 2009 pripravile končno različico v obliki poročila Komisije o pregledu glede metomila.
The new assessment by the rapporteur Member State and the new conclusion by the EFSA concentrated on the concerns that lead to the non-inclusion.
Nova ocena države poročevalke in novi sklep agencije EFSA sta največ pozornosti namenila pomislekom, ki so bili razlog za nevključitev.
Those were the unacceptable operator exposure, the inconclusive nature of the exposure assessment for workers and bystanders and the high risk for birds, mammals, aquatic organisms, bees and other non-target arthropods.
Ti so bili nesprejemljiva izpostavljenost uporabnikov, nezadostna ocena izpostavljenosti delavcev in drugih navzočih ter visoko tveganje za ptice, sesalce, vodne organizme, čebele in druge neciljne členonožce.
New data and information were submitted by the notifier in the new dossier and a new assessment was performed, as included in the additional report and in the EFSA Scientific Report for methomyl.
Predlagatelj je v novi dokumentaciji predložil nove podatke in informacije in izvedena je bila nova ocena, kot je vključena v dodatno poročilo in v znanstveno poročilo EFSA za metomil.
As a consequence, it was shown that acceptable levels of operator exposure can be achieved, if protective equipment, in addition to that referred to in the original dossier, is worn.
S tem je bilo pokazano, da je mogoče z uporabo zaščitne opreme, poleg tiste, predvidene v prvotni dokumentaciji, doseči sprejemljive ravni izpostavljenosti uporabnikov.
As regards the risk to workers and bystanders, it has been clarified that no unacceptable risks are expected from the uses as supported in the resubmitted dossier.
V zvezi s tveganjem za delavce in druge navzoče je bilo pojasnjeno, da se pri uporabi, kot je predvidena v ponovno predloženi dokumentaciji, ne pričakujejo nesprejemljiva tveganja.
Finally, the risk to birds, mammals, aquatic organisms, bees and non-target arthropods may be considered as acceptable, provided that the lowest supported application rate is applied and that appropriate risk management measures are implemented.
Končno je tudi tveganje za ptice, sesalce, vodne organizme, čebele in neciljne členonožce mogoče imeti za sprejemljivo, če se uporabi najmanjša predvidena količina in sprejmejo ustrezni ukrepi za obvladovanje tveganja.
Consequently, the additional data and information provided by the notifier permit to eliminate the specific concerns that led to the non-inclusion.
Zato dodatni podatki in informacije, ki jih je predložil prijavitelj, omogočajo odpravo posameznih pomislekov, ki so bili razlog za nevključitev.
It has appeared from the various examinations made that plant protection products containing methomyl 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 raziskave so pokazale, da je za fitofarmacevtska sredstva, ki vsebujejo metomil, mogoče pričakovati, da v splošnem izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include methomyl in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti metomil v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
However, to exclude any risk of intentional or unintentional poisoning, it is appropriate to require repelling and/or emetic agents to be incorporated in plant protection products containing methomyl and to authorise use by professionals only.
Vendar pa je zaradi izključitve tveganja namerne ali nenamerne zastrupitve primerno, da se za fitofarmacevtska sredstva, ki vsebujejo metomil, predpiše dodatek repelentov in/ali emetikov in odobri izključno profesionalna uporaba.
Done at Brussels, 31 August 2009.
V Bruslju, 31. avgusta 2009
OJ L 255, 29.9.2007, p. 40.
UL L 255, 29.9.2007, str. 40.
EFSA Scientific Report (2008) 222 — Conclusion regarding the peer review of the pesticide risk assessment of the active substance methomyl (re-issued on 19 December 2008).
Znanstveno poročilo EFSA (2008) 222 – Sklep o strokovnem pregledu ocene nevarnosti pesticidov z aktivno snovjo metomil (ponovno izdano: 19. decembra 2008).
CAS No: 16752-77-50
Št. CAS: 16752-77-50
CIPAC No: 264
Št. CIPAC: 264
Only uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.
Registrira se lahko samo kot insekticid za zelenjavo, kjer količine ne presegajo 0,25 kg aktivne snovi na hektar pri posameznem nanosu in največ dveh nanosih v sezoni.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za metomil in zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 12. junija 2009.
the protection of birds,
zaščito ptic,
the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles,
zaščito vodnih organizmov: pogoji registracije po potrebi vključujejo ukrepe za zmanjšanje tveganja, npr. varovalne pasove, zmanjševanje odtekanja ter šobe za preprečevanje zanašanja škropiva,
the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied,
zaščito neciljnih členonožcev, zlasti čebel: sprejmejo se ukrepi za zmanjšanje tveganja, da se prepreči vsak stik s čebelami.
Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.
Države članice poskrbijo, da pripravki na osnovi metomila vsebujejo učinkovite repelente in/ali emetike.
Where appropriate, conditions of authorisation shall include further risk mitigation measures.’
Pogoji registracije po potrebi vključujejo nadaljnje ukrepe za zmanjšanje tveganja.“
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 January 2010 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. januarja 2010.
the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment.
varnost uporabnikov: v pogojih uporabe se predpiše uporaba ustrezne osebne zaščitne opreme.
Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment,
Posebno pozornost je treba nameniti izpostavljenosti uporabnikov, ki uporabljajo nahrbtne naprave ali drugo ročno opremo za nanašanje,
Council Directive 2009/116/EC
Direktiva Sveta 2009/116/ES
amending Directive 91/414/EEC to include paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 as active substances
o spremembi Direktive 91/414/EGS zaradi vključitve parafinskih olj št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 kot aktivnih snovi
Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market 2 years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.
Člen 8(2) Direktive 91/414/EGS določa, da lahko država članica v dvanajstih letih po notifikaciji navedene direktive registrira za dajanje v promet fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, ki niso uvrščene v Prilogo I k navedeni direktivi in so v prometu že dve leti po datumu notifikacije, medtem ko se navedene snovi postopno preučujejo v okviru delovnega programa.
Commission Regulations (EC) No 1112/2002 [2] and (EC) No 2229/2004 [3] lay down the detailed rules for the implementation of the fourth 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. 1112/2002 [2] in (ES) št. 2229/2004 [3] določata podrobna pravila za izvajanje četrte faze delovnega programa iz člena 8(2) Direktive 91/414/EGS in seznam aktivnih snovi, ki jih je treba oceniti zaradi možne vključitve v Prilogo I k Direktivi 91/414/EGS.
That list includes paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3.
Seznam vključuje parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3.
For paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 1112/2002 and (EC) No 2229/2004 for a range of uses proposed by the notifier.
Vplivi parafinskih olj št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 na zdravje ljudi in okolje so bili ocenjeni v skladu z določbami uredb (ES) št. 1112/2002 in (ES) št. 2229/2004 za vrste uporab, 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 10(1) of Regulation (EC) No 2229/2004.
Poleg tega navedeni uredbi določata države članice poročevalke, ki morajo Evropski agenciji za varnost hrane (EFSA) v skladu s členom 10(1) Uredbe (ES) št. 2229/2004 predložiti ustrezna poročila o oceni in priporočila.
For paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 the rapporteur Member State was Greece and all relevant information was submitted on 6 May 2008.
Država članica poročevalka za parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 je bila Grčija, vsi ustrezni podatki pa so bili predloženi 6. maja 2008.
The assessment report has been peer reviewed by the Member States and the EFSA and presented to the Commission on 19 December 2008 in the format of the EFSA Scientific Report for paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3.
Poročilo o oceni so strokovno pregledale države članice in EFSA ter ga 19. decembra 2008 predložile Komisiji v obliki znanstvenega poročila EFSA o parafinskih oljih št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3.
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 12 April 2009 in the format of the Commission review report for paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3.
To poročilo so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 12. aprila 2009 v obliki poročila Komisije o pregledu glede parafinskih olj št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3.
During the evaluation of these active substances, a number of concerns have been identified.
Med ocenjevanjem teh aktivnih snovi so se pojavili številni pomisleki.
In particular, the evidence produced during this evaluation was not sufficient to demonstrate a safe use with respect to operators, workers, bystanders and consumers.
Zlasti podatki, pridobljeni med ocenjevanjem, niso zadostovali za dokaz varne uporabe za izvajalce tretiranja, delavce, druge navzoče osebe in potrošnike.
Consequently, it was not possible to conclude, on the basis of the information made available at that stage, that paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 met the criteria for inclusion in Annex I to Directive 91/414/EEC.
Zato na podlagi podatkov, predloženih v tej fazi, ni bilo mogoče skleniti, da parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 izpolnjujejo pogoje za vključitev v Prilogo I k Direktivi 91/414/EGS.
The Commission invited the notifier to submit its comments on the results of the peer review and on its intention or not to further support the substances.
Komisija je prijavitelja pozvala, naj predloži pripombe o rezultatih strokovnega pregleda in sporoči, ali bo še naprej vztrajal pri vključitvi navedenih snovi na seznam.
However, despite the arguments put forward by the notifier, the Commission initially found that the concerns identified could not be completely eliminated.
Toda Komisija je kljub argumentom, ki jih je predložil prijavitelj, najprej ugotovila, da se navedenih pomislekov ne da popolnoma odpraviti.
However, in the light of the information before the Council it appears that the concerns are related to the lack of specifications and should be solved when the purity of the substances is demonstrated.
Glede na informacije, ki jih ima Svet, pa je videti, da se pomisleki nanašajo na pomanjkanje lastnosti in bi morali biti odpravljeni pri dokazovanju čistosti snovi.
In particular, as stated in the EFSA scientific report if it can be demonstrated that paraffin oils are of high purity (i.e. 100 %) no toxicological concern should be raised.
Kot je navedeno v znanstvenem poročilu EFSA, pomislekov s toksikološkega vidika ne bi smelo biti predvsem, če se lahko dokaže, da so parafinska olja zelo čista (npr. 100 %).
For paraffins, specifications are set by the European Pharmacopoeia.
Lastnosti parafinov so določene v Evropski farmakopeji.
It may be expected that, under the proposed conditions of use, plant protection products containing paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular where they meet such technical specifications.
Za fitofarmacevtska sredstva, ki vsebujejo parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3, se lahko pričakuje, da pod predvidenimi pogoji uporabe na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, predvsem, če izpolnjujejo zadevne tehnične lastnosti.
It is therefore appropriate to include paraffin oils in Annex I subject to the submission from the notifiers of confirmatory data to demonstrate the compliance of the substances with such specifications.
Zato je ustrezno, da se parafinska olja vključijo v Prilogo I, če prijavitelji predložijo potrdilne podatke, ki dokazujejo skladnost snovi s temi lastnostmi.
Therefore, it is appropriate as regards paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 to require that the notifier submits further information on technical specifications of the active substances.
Zato je primerno glede parafinskih olj št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 zahtevati, da prijavitelj predloži dodatne podatke o tehničnih lastnostih aktivnih snovi.
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 bi bilo treba določiti ustrezen rok, v katerem se države članice in zainteresirane strani lahko pripravijo na izpolnjevanje novih zahtev pri vključitvi.
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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 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, bi bilo treba državam članicam omogočiti, da v šestih mesecih po vključitvi snovi pregledajo sedanje registracije fitofarmacevtskih sredstev, ki vsebujejo parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3, in zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti člena 13 in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami iz Direktive 91/414/EGS sedanje registracije po potrebi spremenijo, nadomestijo ali prekličejo.
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 navedenega roka je treba določiti daljše obdobje za predložitev in oceno celotne dokumentacije iz Priloge III posameznega fitofarmacevtskega sredstva za vsako nameravano uporabo v skladu z enotnimi načeli iz Direktive 91/414/EGS.
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 nobenih novih obveznosti v primerjavi z doslej sprejetimi direktivami o spremembah Priloge I.
In the absence of an opinion of the Standing Committee on the Food Chain and Animal Health, the Commission has been unable to adopt the provisions it envisaged under the procedure laid down in Article 19 of Directive 91/414/EEC.
Stalni odbor za prehranjevalno verigo in zdravje živali še ni predložil mnenja, zato Komisija ni mogla sprejeti določb, ki jih je nameravala sprejeti v skladu s postopkom iz člena 19 Direktive 91/414/EGS.
They shall apply those provisions from 1 July 2010.
Uporabljajo se od 1. julija 2010.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 as active substances by 30 June 2010.
Države članice v skladu z Direktivo 91/414/EGS do 30. junija 2010 po potrebi spremenijo ali prekličejo sedanje registracije za fitofarmacevtska sredstva, ki kot aktivno snov vsebujejo parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 are met, with the exception of those identified in part B of the entry 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 navedenega datuma zlasti preverijo, ali so izpolnjeni pogoji iz Priloge I k navedeni direktivi v zvezi s parafinskimi olji št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3, razen tistih iz dela B besedila o navedenih aktivnih snoveh, 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 either as the only active substances or together with several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2009 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 kot edino aktivno snov ali skupaj z drugimi aktivnimi snovmi, ki so vključene v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. decembra 2009. Države članice znova 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 besedila o parafinskih oljih št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 iz Priloge I k navedeni direktivi.
in the case of a product containing paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 as the only active substances, where necessary, amend or withdraw the authorisation by 30 June 2014 at the latest; or
po potrebi najpozneje do 30. junija 2014 spremenijo ali prekličejo registracijo, če sredstvo vsebuje parafinska olja št. CAS 64742-46-7, CAS 72623-86-0 in CAS 97862-82-3 kot edino aktivno snov, ali