natgillin/translations-raw huggingface dataset:
in the case of a product containing Candida oleophila strain O as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 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 Candida oleophila, sev O, kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. marca 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.
Collection number: MUCL40654
številka zbirke: MUCL40654
Nominal content: 3 × 1010 CFU/g dried product
Nominalna vsebnost: 3 × 1010 CFU/g suhega sredstva
Range: 6 × 109 – 1 × 1011 CFU/g dried product
Razpon: 6 × 109 – 1 × 1011 CFU/g suhega sredstva
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 Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 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 Candida oleophila, sev O, ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 15. marca 2013.
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 Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 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 Candida oleophila, sev O, ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 15. marca 2013.“
For Candida oleophila strain O the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/380/EC [3].
Z Odločbo Komisije 2007/380/ES [3] je bilo potrjeno, da Candida oleophila, sev O, izpolnjuje pogoje iz člena 80(1)(a) Uredbe (ES) št. 1107/2009.
Commission Implementing Regulation (EU) No 374/2013
Izvedbena uredba Komisije (EU) št. 374/2013
concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.)
o izdaji dovoljenja za pripravek iz Clostridium butyricum (FERM BP-2789) kot krmni dodatek za piščance za nesnice (imetnik dovoljenja Miyarisan Pharmaceutical Co. Ltd., ki ga zastopa Miyarisan Pharmaceutical Europe S.L.U.)
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of the preparation of Clostridium butyricum (FERM BP-2789) for chickens reared for laying, requesting that the additive be classified in the additive category ‘zootechnical additives’.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za novo uporabo pripravka iz Clostridium butyricum (FERM BP-2789) pri piščancih za nesnice in njegovo uvrstitev v kategorijo dodatkov „zootehnični dodatki“.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 December 2012 [4] that, under the proposed conditions of use, the preparation of Clostridium butyricum (FERM BP-2789) does not have an adverse effect on animal health, human health and the environment.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 11. decembra 2012 [4] navedla, da pripravek iz Clostridium butyricum (FERM BP-2789) pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ter na okolje.
It also concluded that the additive shows some potential to improve performance in chickens reared for laying.
Navedla je tudi, da bi lahko dodatek izboljšal proizvodne lastnosti piščancev za nesnice.
The assessment of the preparation of Clostridium butyricum (FERM BP-2789) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena pripravka iz Clostridium butyricum (FERM BP-2789) je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.
Miyarisan Pharmaceutical Co.Ltd., ki ga zastopa Miyarisan Pharmaceutical Europe S.L.U.
Preparation of Clostridium butyricum (FERM BP-2789) containing in solid form a minimum of 5 × 108 CFU/g additive.
Pripravek iz Clostridium butyricum (FERM BP-2789) z vsebnostjo najmanj 5 × 108 CFU/g dodatka v trdi obliki.
The use is allowed in feed containing the authorised coccidiostats: monensin sodium, diclazuril, salinomycin sodium or lasalocid sodium.
Uporaba je dovoljena v krmi, ki vsebuje dovoljene kokcidiostatike: natrijev monenzin, diklazuril, natrijev salinomicin ali lasalocid natrij.
For safety: breathing protection and safety glasses shall be used during the handling.
Zaradi varnosti je treba med ravnanjem uporabljati zaščito za dihala ter zaščitna očala in rokavice.
14 May 2023
14. maj 2023
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additives
Podrobnosti o analitskih metodah so na voljo na naslednjem naslovu referenčnega laboratorija Evropske unije: www.irmm.jrc.be/crl-feed-additives.
Commission Implementing Regulation (EU) No 375/2013
Izvedbena uredba Komisije (EU) št. 375/2013
approving the active substance spiromesifen, 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 spiromesifen v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet in spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 18 April 2002 an application from Bayer CropScience AG for the inclusion of the active substance spiromesifen in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Združeno kraljestvo 18. aprila 2002 prejelo zahtevek družbe Bayer CropScience AG za vključitev aktivne snovi spiromesifen v Prilogo I k Direktivi 91/414/EGS.
Decision 2003/105/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Z Odločbo 2003/105/ES je bilo potrjeno, da je dokumentacija „popolna“ v smislu načelnega izpolnjevanja zahtev po podatkih in informacijah iz prilog II in III k Direktivi 91/414/EGS.
The designated rapporteur Member State submitted a draft assessment report on 9 March 2004.
Država članica poročevalka je 9. marca 2004 predložila osnutek poročila o oceni.
This draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’) and a final discussion took place on 26 April 2007.
Ta osnutek poročila o oceni so pregledale države članice in Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija), 26. aprila 2007 pa je potekala končna razprava.
The Authority presented to the Commission its conclusion [4] on the review of the pesticide risk assessment of the active substance spiromesifen on 13 June 2007.
Agencija je 13. junija 2007 Komisiji predložila sklep [4] o pregledu ocene tveganja pesticidov z aktivno snovjo spiromesifen.
The designated rapporteur Member State assessed all additional information and submitted an Addendum to the draft assessment report on 28 September 2009.
Država članica poročevalka je ocenila vse dodatne informacije in 28. septembra 2009 predložila dodatek k osnutku poročila o oceni.
The Addendum to the draft assessment report was reviewed by the Member States and the Authority.
Dodatek k osnutku poročila o oceni so pregledale države članice in Agencija.
The Authority presented to the Commission its second conclusion on the review of the pesticide risk assessment of the active substance spiromesifen [5] on 19 September 2012.
Agencija je 19. septembra 2012 Komisiji predložila drugi sklep o pregledu ocene tveganja pesticidov z aktivno snovjo spiromesifen [5].
The updated 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 the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for spiromesifen.
Posodobljeni 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 osnutka poročila o oceni pripravile 15. marca 2013 v obliki poročila Komisije o pregledu spiromesifena.
It has appeared from the various examinations made that plant protection products containing spiromesifen 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 spiromesifen, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) ter člena 5(3) Direktive 91/414/EGS, zlasti pri uporabah, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to approve spiromesifen.
Zato je primerno, da se spiromesifen odobri.
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing spiromesifen.
Državam članicam bi bilo treba omogočiti, da v šestih mesecih po odobritvi pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo spiromesifen.
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 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 [6] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje iz 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 [6], so pokazale, da se lahko pri razlagi obveznosti imetnikov veljavnih registracij glede dostopa do podatkov pojavijo težave.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances [7] 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 z dne 25. maja 2011 o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede seznama registriranih aktivnih snovi [7].
The active substance spiromesifen, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov spiromesifen, kot je opredeljena v Prilogi I, se odobri 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 spiromesifen as an active substance by 31 March 2014.
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 31. marca 2014 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo spiromesifen kot aktivno snov.
By way of derogation from paragraph 1, for each authorised plant protection product containing spiromesifen 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 September 2013 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 znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje spiromesifen kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, najpozneje do 30. septembra 2013 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 spiromesifen as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or
če sredstvo vsebuje spiromesifen kot edino aktivno snov, po potrebi spremenijo ali prekličejo registracijo najpozneje do 31. marca 2015, ali
in the case of a product containing spiromesifen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 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 spiromesifen kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. marca 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.
EFSA Scientific Report (2007) 105, 1-69.
Znanstveno poročilo EFSA (2007) 105, 1–69.
EFSA Journal 2012; 10(10):2873.
EFSA Journal (2012); 10(10):2873.
CAS No 283594-90-1
št. CAS 283594-90-1
CIPAC No 747
št. CIPAC 747
≥ 965 g/kg (racemic)
≥ 965 g/kg (racemičen)
The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.
Nečistoča N,N-dimetilacetamid je toksična in ne sme presegati 4 g/kg tehničnega materiala.
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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 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 spiromesifena ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 15. marca 2013.
the long-term risk to aquatic invertebrates,
dolgoročno tveganje za vodne nevretenčarje,
the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,
tveganje za kožekrilce opraševalce in neciljne členonožce, če izpostavljenost ni zanemarljiva,
the protection of workers and operators.
zaščito delavcev in izvajalcev.
The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.
Vlagatelj predloži potrditvene informacije o ponovnem izračunu predvidene koncentracije v podtalnici (PECGW) s FOCUS GW scenarijem, prilagojenim predvideni uporabi z vrednostjo Q10 v višini 2,58.
For spiromesifen the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/105/EC [3].
Z Odločbo Komisije 2003/105/ES [3] je bilo potrjeno, da spiromesifen izpolnjuje pogoje iz člena 80(1)(a) Uredbe (ES) št. 1107/2009.
In its conclusion, the Authority did not take into account all information submitted by the applicant before 26 April 2007.
Agencija v svojem sklepu ni upoštevala vseh informacij, ki jih je vlagatelj predložil do 26. aprila 2007.
The Commission requested the Authority to revise its conclusion and to take into account all information submitted.
Komisija je Agencijo zaprosila, naj pregleda svoj sklep in upošteva vse predložene informacije.
Commission Implementing Regulation (EU) No 376/2013
Izvedbena uredba Komisije (EU) št. 376/2013
Commission Implementing Regulation (EU) No 378/2013
Izvedbena uredba Komisije (EU) št. 378/2013
approving the active substance Paecilomyces fumosoroseus strain FE 9901, 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 Paecilomyces fumosoroseus, sev FE 9901, v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet in spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
In accordance with Article 6(2) of Directive 91/414/EEC Belgium received on 4 February 2004 an application from FuturEco S.L. for the inclusion of the active substance Paecilomyces fumosoroseus strain FE 9901 in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Belgija 4. februarja 2004 prejela zahtevek družbe FuturEco S.L. za vključitev aktivne snovi Paecilomyces fumosoroseus, sev FE 9901, v Prilogo I k Direktivi 91/414/EGS.
Decision 2008/565/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Z Odločbo 2008/565/ES je bilo potrjeno, da je dokumentacija „popolna“ v smislu načelnega izpolnjevanja zahtev po podatkih in informacijah iz prilog II in III k Direktivi 91/414/EGS.
The designated rapporteur Member State submitted a draft assessment report on 29 March 2007.
Država članica poročevalka je 29. marca 2007 predložila osnutek poročila o oceni.
The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance Paecilomyces fumosoroseus strain FE 9901 [4] on 20 August 2012.
Agencija je 20. avgusta 2012 Komisiji predložila sklep o pregledu ocene tveganja pesticidov z aktivno snovjo Paecilomyces fumosoroseus, sev FE 9901 [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 the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for Paecilomyces fumosoroseus strain FE 9901.
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 osnutka poročila o oceni pripravile 15. marca 2013 v obliki poročila Komisije o pregledu Paecilomyces fumosoroseus, sev FE 9901.
It has appeared from the various examinations made that plant protection products containing Paecilomyces fumosoroseus strain FE 9901 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 Paecilomyces fumosoroseus, sev FE 9901, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) ter člena 5(3) Direktive 91/414/EGS, zlasti pri uporabah, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to approve Paecilomyces fumosoroseus strain FE 9901.
Zato je primerno, da se Paecilomyces fumosoroseus, sev FE 9901, odobri.
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Paecilomyces fumosoroseus strain FE 9901.
Državam članicam bi bilo treba omogočiti, da v šestih mesecih po odobritvi pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo Paecilomyces fumosoroseus, sev FE 9901.
The active substance Paecilomyces fumosoroseus strain FE 9901, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov Paecilomyces fumosoroseus, sev FE 9901, kot je opredeljena v Prilogi I, se odobri 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 Paecilomyces fumosoroseus strain FE 9901 as an active substance by 31 March 2014.
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 31. marca 2014 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo Paecilomyces fumosoroseus, sev FE 9901, kot aktivno snov.
By way of derogation from paragraph 1, for each authorised plant protection product containing Paecilomyces fumosoroseus strain FE 9901 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 September 2013 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 znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje Paecilomyces fumosoroseus, sev FE 9901, kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, najpozneje do 30. septembra 2013 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 Paecilomyces fumosoroseus strain FE 9901 as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or
če sredstvo vsebuje Paecilomyces fumosoroseus, sev FE 9901, kot edino aktivno snov, po potrebi spremenijo ali prekličejo registracijo najpozneje do 31. marca 2015, ali