natgillin/translations-raw huggingface dataset:
Conclusion on the peer review of the pesticide risk assessment of the active substance plant oils/clove oil.
Sklep o strokovnem pregledu ocene tveganja za pesticide za aktivno snov rastlinska olja/olje nageljnovih žbic.
[43 pp.] doi:10.2903/j.efsa.2012.2506.
[43 str.] doi:10.2903/j.efsa.2012.2506.
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 241 on the active substance plant oils/clove oil is replaced by the following:
V delu A Priloge k Izvedbeni uredbi (EU) št. 540/2011 se vrstica 241 o aktivni snovi rastlinska olja/olje nageljnovih žbic nadomesti z naslednjim:
CAS No 84961-50-2 (clove oil)
št. CAS 84961-50-2 (olje nageljnovih žbic)
97-53-0 (Eugenol — main component)
97-53-0 (evgenol – glavna sestavina)
CIPAC No 906
št. CIPAC 906
Relevant impurity: methyl eugenol maximum 0,1 % of the technical material
Relevantna nečistoča: metil evgenol največ 0,1 % tehničnega materiala
Only indoor uses as post-harvest fungicide and bactericide may be authorised.
Registrira se lahko samo kot fungicid in baktericid po spravilu pridelka v zaprtih prostorih.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.
V tej celoviti oceni so države članice zlasti pozorne na zaščito izvajalcev in delavcev ter zagotovijo, da je v pogojih uporabe po potrebi predpisana uporaba ustrezne zaščitne opreme.
The notifier shall submit confirmatory information as regards
Prijavitelj predloži potrditvene informacije o
the technical specification;
tehničnih specifikacijah;
data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product.
podatkih primerjave izpostavljenosti rastlinskim oljem/olju nageljnovih žbic, evgenolu in metil evgenolu v naravnem okolju ter izpostavljenosti rastlinskim oljem/olju nageljnovih žbic, ki se uporabljajo kot fitofarmacevtsko sredstvo.
This data shall cover human exposure.
Ti podatki vključujejo izpostavljenost ljudi.
The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.’
Prijavitelj Komisiji, državam članicam in Agenciji navedene informacije predloži do 30. aprila 2016.“
Commission Implementing Regulation (EU) No 142/2014
Izvedbena uredba Komisije (EU) št. 142/2014
Commission Implementing Regulation (EU) No 143/2014
Izvedbena uredba Komisije (EU) št. 143/2014
approving the active substance pyridalyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobritvi aktivne snovi piridalil v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet ter o spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 9 October 2006 an application from Sumitomo Chemical Agro Europe S.A.S. for the inclusion of the active substance pyridalyl in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Avstrija 9. oktobra 2006 prejela zahtevek podjetja Sumitomo Chemical Agro Europe S.A.S. za vključitev aktivne snovi piridalil v Prilogo I k Direktivi 91/414/EGS.
The designated rapporteur Member State submitted a draft assessment report on 8 January 2009.
Država članica, ki je bila imenovana za poročevalko, je 8. januarja 2009 predložila osnutek poročila o oceni.
The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance pyridalyl [4] on 24 May 2013.
Agencija je 24. maja 2013 Komisiji predložila sklep o oceni tveganja, ki ga predstavljajo pesticidi z aktivno snovjo piridalil [4].
The draft assessment 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 13 December 2013 in the format of the Commission review report for pyridalyl.
Osnutek poročila o oceni in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 13. decembra 2013 v obliki poročila Komisije o pregledu piridalila.
It has appeared from the various examinations made that plant protection products containing pyridalyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the use which was examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo piridalil, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) ter člena 5(3) Direktive 91/414/EGS, zlasti v zvezi z vrsto uporabe, ki je bila proučena in podrobno navedena v poročilu Komisije o pregledu.
It is therefore appropriate to approve pyridalyl.
Zato je primerno, da se piridalil odobri.
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing pyridalyl.
Državam članicam bi bilo treba omogočiti, da v šestih mesecih po odobritvi pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo piridalil.
The active substance pyridalyl, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov piridalil, kot je opredeljena v Prilogi I, je odobrena v skladu s pogoji iz navedene priloge.
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing pyridalyl as an active substance by 31 December 2014.
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 31. decembra 2014 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo piridalil kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
Do navedenega datuma zlasti preverijo, ali so pogoji iz Priloge I k tej uredbi izpolnjeni, razen pogojev iz dela B stolpca o posebnih določbah v navedeni prilogi, in ali ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k Direktivi 91/414/EGS v skladu s pogoji iz člena 13(1) do (4) navedene direktive ter člena 62 Uredbe (ES) št. 1107/2009.
By way of derogation from paragraph 1, for each authorised plant protection product containing pyridalyl as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation.
Z odstopanjem od odstavka 1 države članice najpozneje do 30. junija 2014 znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje piridalil kot edino aktivno snov ali kot eno od aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, po enotnih načelih iz člena 29(6) Uredbe (ES) št. 1107/2009 na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k Direktivi 91/414/EGS, in ob upoštevanju dela B stolpca o posebnih določbah iz Priloge I k tej uredbi.
in the case of a product containing pyridalyl as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or
če sredstvo vsebuje piridalil kot edino aktivno snov, najpozneje do 31. decembra 2015 po potrebi spremenijo ali prekličejo registracijo, ali
in the case of a product containing pyridalyl as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.
če sredstvo vsebuje piridalil kot eno od aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. decembra 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih aktih, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS oziroma s katerimi so bile zadevne snovi odobrene, pri čemer se upošteva poznejši datum.
Commission Decision 2007/669/EC of 15 October 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Adoxophyes orana granulovirus, amisulbrom, emamectin, pyridalil and Spodoptera littoralis nucleopolyhedrovirus in Annex I to Council Directive 91/414/EEC (OJ L 274, 18.10.2007, p. 15).
Odločba Komisije 2007/669/ES z dne 15. oktobra 2007 o načelnem priznavanju popolnosti dokumentacije, predložene v podroben pregled zaradi možne vključitve aktivnih snovi Adoxophyes orana granulovirus, amisulbrom, emamectin, piridalil in Spodoptera littoralis nukleopolihedrovirus v Prilogo I k Direktivi Sveta 91/414/EGS (UL L 274, 18.10.2007, str. 15).
Pyridalyl
piridalil
CAS No 179101-81-6
št. CAS 179101-81-6
CIPAC No 792
št. CIPAC 792
2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether
2,6-dikloro-4-(3,3-dikloroalliloksi)fenil 3-[5-(trifluorometil)-2-piridiloksi]propil eter
Only uses in greenhouses with permanent structure may be authorised.
Registrirajo se lahko samo uporabe v rastlinjakih s trajno strukturo.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu piridalila ter zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 13. decembra 2013.
the risk to re-entry workers;
tveganje za delavce pri ponovnem vstopu;
the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions;
tveganje za podtalnico, kadar se snov uporablja na območjih z občutljivimi tlemi in/ali neugodnimi podnebnimi razmerami;
the risk to birds, mammals and aquatic organisms.
tveganje za ptice, sesalce in vodne organizme.
the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23;
toksikološkem in ekotoksikološkem pomenu nečistoč 4, 13, 16, 22 in 23;
the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse;
pomenu metabolita HTFP in z njim povezano oceno tveganja za podtalnico v zvezi z vsemi uporabami na kmetijskih rastlinah v rastlinjakih;
the risk to aquatic invertebrates.
tveganju za vodne nevretenčarje.
The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016.
Vlagatelj Komisiji, državam članicam in Agenciji predloži ustrezne informacije o točki 1 do 31. Decembra 2014 ter informacije o točkah 2 in 3 do 30. junija 2016.
The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones, by 30 June 2016.
Vlagatelj Komisiji, državam članicam in Agenciji do 30. junija 2016 predloži program spremljanja za oceno možnosti onesnaženja podtalnice z metabolitom HTFP na občutljivih območjih.
The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.
Rezultati navedenega programa spremljanja se državi članici poročevalki, Komisiji in Agenciji do 30. junija 2018 predložijo kot poročilo o spremljanju.
The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016.
Vlagatelj Komisiji, državam članicam in Agenciji do 30. Junija 2016 predloži program spremljanja za oceno možnosti onesnaženja podtalnice z metabolitom HTFP na občutljivih območjih.
The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.’
Rezultati navedenega programa spremljanja se državi članici poročevalki, Komisiji in Agenciji do 30. junija 2018 predložijo kot poročilo o spremljanju.“
For pyridalyl the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC [3].
Z Odločbo Komisije 2007/669/ES [3] je bilo potrjeno, da piridalil izpolnjuje pogoje iz člena 80(1)(a) Uredbe (ES) št. 1107/2009.
Commission Implementing Regulation (EU) No 144/2014
Izvedbena uredba Komisije (EU) št. 144/2014
approving the active substance valifenalate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobritvi aktivne snovi valifenalat v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet ter o spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
In accordance with Article 6(2) of Directive 91/414/EEC Hungary received on 2 September 2005 an application from Isagro S.p.A.
V skladu s členom 6(2) Direktive 91/414/EGS je Madžarska 2. septembra 2005 prejela zahtevek podjetja Isagro S.p.A.
for the inclusion of the active substance valifenalate in Annex I to Directive 91/414/EEC.
za vključitev aktivne snovi valifenalat v Prilogo I k Direktivi 91/414/EGS.
For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant.
Za navedeno aktivno snov so bili v skladu z določbami člena 6(2) in (4) Direktive 91/414/EGS ocenjeni vplivi na zdravje ljudi in živali ter na okolje pri vrstah uporabe, ki jih je predlagal vlagatelj.
The designated rapporteur Member State submitted a draft assessment report on 19 February 2008.
Država članica poročevalka je 19. februarja 2008 predložila osnutek poročila o oceni.
In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 [5] additional information was requested from the applicant on 18 July 2011.
V skladu s členom 11(6) Uredbe Komisije (EU) št. 188/2011 [5] so se od vlagatelja 18. julija 2011 zahtevale dodatne informacije.
The evaluation of the additional data by Hungary was submitted in the format of an updated draft assessment report in April 2012.
Madžarska je aprila 2012 oceno dodatnih podatkov predložila v obliki posodobljenega osnutka poročila o oceni.
The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance valifenalate [6] on 31 May 2013.
Agencija je 31. maja 2013 Komisiji predložila sklep o oceni tveganja pesticidov z aktivno snovjo valifenalat [6].
The draft assessment 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 13 December 2013 in the format of the Commission review report for valifenalate.
Osnutek poročila o oceni in sklep Agencije so države članice in Komisija pregledale v Stalnem odboru za prehranjevalno verigo in zdravje živali ter končno različico pripravile 13. decembra 2013 v obliki poročila Komisije o pregledu valifenalata.
It has appeared from the various examinations made that plant protection products containing valifenalate may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) 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 se za fitofarmacevtska sredstva, ki vsebujejo valifenalat, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) ter člena 5(3) 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 approve valifenalate.
Zato je primerno, da se valifenalat odobri.
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing valifenalate.
Državam članicam bi bilo treba po odobritvi omogočiti šestmesečno obdobje, da pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo valifenalat.
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 [7] 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, ocenjenih na podlagi Uredbe Komisije (EGS) št. 3600/92 [7], 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 accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 [8] should be amended accordingly.
V skladu s členom 13(4) Uredbe (ES) št. 1107/2009 bi bilo treba ustrezno spremeniti Prilogo k Izvedbeni uredbi Komisije (EU) št. 540/2011 [8].
The active substance valifenalate, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov valifenalat, kot je opredeljena v Prilogi I, je odobrena v skladu s pogoji iz navedene priloge.
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing valifenalate as an active substance by 31 December 2014.
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 31. decembra 2014 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo valifenalat kot aktivno snov.
By way of derogation from paragraph 1, for each authorised plant protection product containing valifenalate as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation.
Z odstopanjem od odstavka 1 države članice najpozneje do 30. junija 2014 znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje valifenalat kot edino aktivno snov ali kot eno od aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, po enotnih načelih iz člena 29(6) Uredbe (ES) št. 1107/2009 na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k Direktivi 91/414/EGS, in ob upoštevanju stolpca o posebnih določbah iz Priloge I k tej uredbi.
in the case of a product containing valifenalate as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or
če sredstvo vsebuje valifenalat kot edino aktivno snov, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. decembra 2015; ali
in the case of a product containing valifenalate as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.
če sredstvo vsebuje valifenalat kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. decembra 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih aktih, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS oziroma s katerimi so bile zadevne snovi odobrene, pri čemer se upošteva poznejši datum.
Commission Decision 2006/586/EC of 25 August 2006 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of chromafenozide, halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic virus — weak strain in Annex I to Council Directive 91/414/EEC (OJ L 236, 31.8.2006, p. 31).
Odločba Komisije št. 2006/586/ES z dne 25. avgusta 2006 o načelnem priznavanju popolnosti dokumentacije, predložene v podroben pregled zaradi možne vključitve kromafenozida, halosulfurona, tembotriona, valifenala in Zucchini yellow mosaic virus – šibkega seva v Prilogo I k Direktivi Sveta 91/414/EGS (UL L 236, 31.8.2006, str. 31).
On 17 June 2013, Isagro S.p.A. informed the Commission that the ownership of the active substance was transferred to Belchim Crop Protection SA/NV.
Podjetje Isagro S.p.A. je 17. junija 2013 obvestilo Komisijo, da je bilo lastništvo aktivne snovi preneseno na podjetje Belchim Crop Protection SA/NV.
CAS No 283159-90-0
št. CAS 283159-90-0
CIPAC No 857
št. CIPAC 857
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu valifenalata ter zlasti dodatka I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 13. decembra 2013.
In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.
V tej celoviti oceni morajo biti države članice zlasti pozorne na tveganje za vodne organizme.
The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater.
Vložnik predloži potrditvene informacije o morebitni kontaminaciji podtalnice z metabolitom S5.
The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
Prijavitelj Komisiji, državam članicam in Agenciji ustrezne informacije predloži do 30. junija 2016.
The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.’
Prijavitelj Komisiji, državam članicam in Agenciji ustrezne informacije predloži do 30. junija 2016.“