natgillin/translations-raw huggingface dataset:
Provided that oryzalin becomes classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council [7] as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information confirming the relevance of the metabolites OR13 [8] and OR15 [9], and the corresponding groundwater risk assessment.
Če bo orizalin v Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta [7] razvrščen v kategorijo „sum povzročitve raka“, zadevne države članice zahtevajo predložitev dodatnih informacij, ki potrjujejo ustreznost metabolitov OR13 [8] in OR15 [9], ter ustrezno oceno tveganja za podtalnico.
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 oryzalin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki izhajajo iz vključitve aktivne snovi v Prilogo I, je državam članicam treba omogočiti, da v šestih mesecih po vključitvi snovi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo orizalin, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi 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 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [10] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje iz prejšnjih vključitev aktivnih snovi v Prilogo I k Direktivi 91/414/EGS, ocenjenih na podlagi Uredbe Komisije (EGS) št. 3600/92 z dne 11. decembra 1992 o podrobnih pravilih za izvajanje prve faze delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet [10], so pokazale, da se lahko pojavijo težave pri razlagi dolžnosti imetnikov obstoječih registracij v zvezi z dostopom do podatkov.
The line concerning oryzalin in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica, ki zadeva orizalin.
Member States shall adopt and publish by 30 November 2011 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 30. novembra 2011 .
They shall apply those provisions from 1 December 2011.
Navedene predpise uporabljajo od 1. decembra 2011 .
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing oryzalin as an active substance by 30 November 2011.
Države članice v skladu z Direktivo 91/414/EGS do 30. novembra 2011 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo orizalin kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to oryzalin are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
Do navedenega datuma zlasti preverijo, ali so pogoji iz Priloge I k navedeni direktivi v zvezi z orizalinom, z izjemo tistih iz dela B besedila o navedeni aktivni snovi, izpolnjeni 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 oryzalin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning oryzalin.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje orizalin kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. maja 2011 , 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 orizalinu iz Priloge I k navedeni direktivi.
in the case of a product containing oryzalin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje orizalin kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo, ali
in the case of a product containing oryzalin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
če sredstvo vsebuje orizalin kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih direktivah, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
Done at Brussels, 4 March 2011.
V Bruslju, 4. marca 2011
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance oryzalin.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo orizalin.
2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.
2-etil-7-nitro-1-propil-1H-benzimidazol-5-sulfonamid.
2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.
2-etil-7-nitro-1H-benzimidazol-5-sulfonamid.
CAS No: 19044-88-3
Št. CAS: 19044-88-3
CIPAC No: 537
Št. CIPAC: 537
N-nitrosodipropylamine:
N-nitrosodipropilamin:
For the implementation of the uniform principles of Annex VI the conclusions of the review report on oryzalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011, shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za orizalin ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 28. januarja 2011.
the operator safety and ensure that conditions of use include the application of adequate personal protective equipment;
varnost izvajalcev tretiranja in zagotoviti, da pogoji uporabe vključujejo uporabo ustrezne osebne zaščitne opreme;
the protection of aquatic organisms and non-target plants;
zaščito vodnih organizmov in neciljnih rastlin;
the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions;
zaščito podtalnice, kadar se aktivna snov uporablja v regijah z občutljivimi tlemi in/ali podnebnimi razmerami;
the risk to herbivorous birds and mammals;
tveganje za rastlinojede ptice in sesalce;
the risk to bees, in the flowering season.
tveganje za čebele v obdobju cvetenja.
The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolites OR13 (2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide) and OR15 (2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide) in vulnerable zones, where appropriate.
Zadevne države članice po potrebi izvedejo programe za spremljanje potencialnega onesnaženja podtalnice z metabolitoma OR13 (2-etil-7-nitro-1-propil-1H-benzimidazol-5-sulfonamid) in OR15 (2-etil-7-nitro-1H-benzimidazol-5-sulfonamid) na občutljivih območjih.
The Member States concerned shall request the submission of confirmatory information as regards:
Zadevne države članice zahtevajo predložitev informacij, ki potrjujejo:
the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12;
specifikacije tehničnega materiala v tržni proizvodnji z ustreznimi analitskimi podatki, vključno z informacijami o ustreznosti nečistot, ki se zaradi zaupnosti navajajo kot nečistote 2, 6, 7, 9, 10, 11, 12;
the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;
ustreznost testnega materiala, ki se uporablja v dokumentaciji o toksičnosti glede na specifikacije tehničnega materiala;
the risk assessment for aquatic organisms;
oceno tveganja za vodne organizme;
the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, provided that oryzalin becomes classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L 353, 31.12.2008, p. 1) as “suspected of causing cancer”.
ustreznost metabolitov OR13 in OR15 ter ustrezno oceno tveganja za podtalnico, če bo orizalin v Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta (UL L 353, 31.12.2008, str. 1) razvrščen v kategorijo ‚sum povzročitve raka‘.
Decision 2008/934/EC provides for the non-inclusion of oryzalin and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev orizalina in preklic registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning oryzalin in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico, ki zadeva orizalin.
The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points 1 and 2 by 1 December 2011, and the information set out in point 3 by 31 May 2013.
Zadevne države članice zagotovijo, da vlagatelj Komisiji predloži informacije iz točk 1 in 2 do 1. decembra 2011 in informacije iz točke 3 do 31. maja 2013.
The information set out in point 4 shall be submitted within 6 months of notification of a decision classifying oryzalin.’
Informacije iz točke 4 se predložijo v šestih mesecih od objave sklepa, ki razvršča orizalin.“
EFSA Journal 2010; 8(9):1707. [59 pp.]. doi:10.2903/j.efsa.2010.1707.
EFSA Journal 2010; 8(9):1707 [59 pp]. doi:10.2903/j.efsa.2010.1707.
Commission Directive 2011/28/EU
Direktiva Komisije 2011/28/EU
amending Council Directive 91/414/EEC to include indolylbutyric acid as active substance and amending Commission Decision 2008/941/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve indolmaslene kisline kot aktivne snovi in o spremembi Odločbe Komisije 2008/941/ES
That list included indolylbutyric acid.
Navedeni seznam je vključeval indolmasleno kislino.
In accordance with Article 24e of Regulation (EC) No 2229/2004 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report.
V skladu s členom 24e Uredbe (ES) št. 2229/2004 je prijavitelj umaknil zahtevek za vključitev navedene aktivne snovi v Prilogo I k Direktivi 91/414/EGS v dveh mesecih od prejema osnutka poročila o oceni.
Consequently, Commission Decision 2008/941/EC of 8 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances [4] was adopted on the non-inclusion of indolylbutyric acid.
Zato je bila v zvezi z nevključitvijo indolmaslene kisline sprejeta Odločba Komisije 2008/941/ES z dne 8. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo navedene snovi [4].
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [5].
Prvotni prijavitelj (v nadaljnjem besedilu: vlagatelj) je v skladu s členom 6(2) Direktive 91/414/EGS vložil nov zahtevek za uporabo pospešenega postopka iz členov 14 do 19 Uredbe Komisije (ES) št. 33/2008 z dne 17. januarja 2008 o podrobnih pravilih za izvajanje Direktive Sveta 91/414/EGS glede rednega in pospešenega postopka za oceno aktivnih snovi, ki so bile del delovnega programa iz člena 8(2) navedene direktive, vendar niso bile vključene v Prilogo I [5].
The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004.
Zahtevek je bil predložen Franciji, ki je bila z Uredbo (ES) št. 2229/2004 imenovana za državo članico poročevalko.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 26 January 2010.
Navedeno poročilo je 26. januarja 2010 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on indolylbutyric acid to the Commission on 3 September 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 3. september 2010 predstavila svoje sklepe o indolmasleni kislini [6].
The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for indolylbutyric acid.
Osnutek poročila o oceni, dodatno poročilo in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 28. januarja 2011 v obliki poročila Komisije o pregledu glede indolmaslene kisline.
It has appeared from the various examinations made that plant protection products containing indolylbutyric acid may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo indolmasleno kislino, lahko pričakuje, da na splošno 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 indolylbutyric acid 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 indolmasleno kislino v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Therefore, it is appropriate to require that the applicant submit further information confirming: the absence of clastogenicity potential of indolylbutyric acid, the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study, and the natural background concentration of indolylbutyric acid in the soil.
Zato je primerno zahtevati, da vlagatelj predloži dodatne informacije, ki potrjujejo: odsotnost možnosti za pojav klastogenosti indolmaslene kisline, parni tlak indolmaslene kisline in zato študijo subkronične inhalacijske toksičnosti ter naravno koncentracijo indolmaslene kisline v tleh.
It is therefore appropriate to amend Decision 2008/941/EC accordingly.
Zato je primerno Direktivo 2008/941/EGS ustrezno spremeniti.
The line concerning indolylbutyric acid in the Annex to Decision 2008/941/EC is deleted.
V Prilogi k Odločbi 2008/941/ES se črta vrstica, ki zadeva indolmasleno kislino.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing indolylbutyric acid as an active substance by 30 November 2011.
Države članice v skladu z Direktivo 91/414/EGS do 30. novembra 2011 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo indolmasleno kislino kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to indolylbutyric acid are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
Do navedenega datuma zlasti preverijo, ali so pogoji iz Priloge I k navedeni direktivi v zvezi z indolmasleno kislino, z izjemo tistih iz dela B besedila o navedeni aktivni snovi, izpolnjeni 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 indolylbutyric acid as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning indolylbutyric acid.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje indolmasleno kislino kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. maja 2011, 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 indolmasleni kislini iz Priloge I k navedeni direktivi.
in the case of a product containing indolylbutyric acid as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje indolmasleno kislino kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo ali
in the case of a product containing indolylbutyric acid as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
če sredstvo vsebuje indolmasleno kislino kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih direktivah, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance indolylbutyric acid.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo indolmaslena kislina.
Indolylbutyric acid
Indolmaslena kislina
CAS No 133-32-4
Št. CAS: 133-32-4
CIPAC No 830
Št. CIPAC: 830
Only uses as plant growth regulator in ornamentals may be authorised.
Registrira se lahko samo kot regulator rasti za okrasne rastline.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za indolmasleno kislino ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 28. januarja 2011.
In this overall assessment Member States shall pay particular attention to the operators and workers safety.
V tej celoviti oceni morajo države članice zlasti zagotavljati varnost izvajalcev tretiranja in delavcev.
Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure.
Pogoji uporabe morajo vključevati uporabo ustrezne osebne zaščitne opreme in ukrepe za zmanjševanje tveganja, da se zmanjša izpostavljenost.
The Member States concerned shall request the submission of further information to confirm:
Zadevne države članice zahtevajo predložitev dodatnih informacij, ki potrjujejo:
the absence of clastogenicity potential of indolylbutyric acid;
odsotnost možnosti za pojav klastogenosti indolmaslene kisline;
the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study;
parni tlak indolmaslene kisline in zato študijo subkronične inhalacijske toksičnosti;
the natural background concentration of indolylbutyric acid in the soil.
naravno koncentracijo indolmaslene kisline v tleh.
The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.’
Zadevne države članice zagotovijo, da vlagatelj take potrditvene informacije predloži Komisiji do 31. maja 2013.“