natgillin/translations-raw huggingface dataset:
Identi-fication number of the additive
Ime imetnika dovoljenja
End of period of authorisation
Enote aktivnosti/kg popolne krmne mešanice z vsebnostjo vlage 12 %
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
Kategorija zootehničnih dodatkov.
Category of zootechnical additives.
Funkcionalna skupina: pospeševalci prebavljivosti
Functional group: digestibility enhancers
alfa-galaktozidaza
Alpha-galactosidase
endo-1,4-beta-glukanaza
Endo-1,4-beta-glucanase
Sestava dodatka
Additive composition
pripravek alfa-galaktozidaze (EC 3.2.1.22), ki jo proizvaja Saccharomyces cerevisiae (CBS 615.94), in endo-1,4-beta-glukanaze (EC 3.2.1.4), ki jo proizvaja Aspergillus niger (CBS 120604), z minimalno aktivnostjo:
Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) with a minium activiy of:
v trdni obliki:
Solid form:
1000 U [1] alfa-galaktozidaze/g,
1000 U [1] alpha-galactosidase/g
5700 U [2] endo-1,4-beta-glukanaze/g,
5700 U [2] endo-1,4- beta-glucanase/g
v tekoči obliki:
Liquid form:
500 U alfa-galaktozidaze/g,
500 U alpha-galactosidase/g
2850 U endo-1,4-beta-glukanaze/g.
2850 U endo-1,4- beta-glucanase/g.
Lastnosti aktivne snovi
Characterisation of the active substance
alfa-galaktozidaza, ki jo proizvaja Saccharomyces cerevisiae (CBS 615.94), endo-1,4-beta-glukanaza, ki jo proizvaja Aspergillus niger (CBS 120604).
Alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) Endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604).
Analitska metoda [3]Določitev:
Method of Analysis [3]Determination:
alfa-galaktozidaza: kolometrična metoda merjenja p-nitrofenola, ki se med delovanjem alfa-galaktozidaze sprosti iz substrata p-nitrofenil-alfa-galaktopiranozida,
Alpha-galactosidase: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate,
endo-1,4-beta-glukanaza: kolorimetrična metoda merjenja vodotopnega barvila, ki se med delovanjem endo-1,4-beta-glukanaze sprosti iz substrata ječmenovega glukana, navzkrižno vezanega z azurinom.
endo-1,4-beta-glucanase: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.
piščanci za pitanje
Chickens for fattening
50 U alfa-galaktozidaze
50 U alpha-galactosidase
285 U endo-1,4-beta-glukanaze
285 U endo-1,4-beta-glucanase
V navodilih za uporabo dodatka in premiksa je treba navesti temperaturo skladiščenja, rok trajanja in obstojnost pri peletiranju.
In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
Najvišji priporočeni odmerek:
Maximum recommended dose:
100 U alfa-galaktozidaze/kg,
100 U alpha-galactosidase/kg;
570 U endo-1,4-beta-glukanaze/kg.
570 U endo-1,4-beta-glucanase/kg.
Zaradi varnosti je treba pri ravnanju uporabljati zaščito za dihala, zaščitna očala in rokavice.
For safety: breathing protection glasses and gloves shall be used during handling.
9. april 2022
9 April 2022
1 U je količina encima, ki sprosti 1 μmol p-nitrofenola na minuto iz p-nitrofenil-alfa-galaktopiranozida (pNPG) pri pH 5,0 in temperaturi 37 °C.
1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.
1 U je količina encima, ki sprosti 1 mg reduktivnih sladkorjev (ekvivalentov glukoze) iz beta-glukana na minuto pri pH 5,0 in temperaturi 50 °C.
1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.
Podrobnosti o analitskih metodah so na voljo na naslovu referenčnega laboratorija: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports“
Commission Implementing Regulation (EU) 2015/1105
Izvedbena uredba Komisije (EU) 2015/1105
concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation Biomin GmbH)
o izdaji dovoljenja za pripravek iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913 kot krmni dodatek za piščance za nesnice in manjše vrste perutnine, razen nesnic, o izdaji dovoljenja za uporabo navedenega krmnega dodatka v vodi, ki jo pijejo piščanci za pitanje, ter o spremembi Izvedbene uredbe (EU) št. 544/2013, kar se tiče najvišje vsebnosti navedenega krmnega dodatka v popolni krmni mešanici in njegove združljivosti s kokcidiostatiki (imetnik dovoljenja Biomin GmbH)
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1] , and in particular Article 9(2) and Article 13(2) thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [1] in zlasti člena 9(2) in člena 13(2) Uredbe,
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and modifying such authorisation.
Uredba (ES) št. 1831/2003 določa izdajo dovoljenj za dodatke za uporabo v prehrani živali ter razloge in postopke za izdajo in spremembo takih dovoljenj.
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 and for an amendment of the terms of the current authorisation for chickens for fattening granted by Commission Implementing Regulation (EU) No 544/2013 [2].
V skladu s členom 7 Uredbe št. 1831/2003 je bil predložen zahtevek za novo uporabo pripravka iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913 ter za spremembo pogojev obstoječega dovoljenja za piščance za pitanje, izdanega na podlagi Izvedbene uredbe Komisije (EU) št. 544/2013 [2].
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support that amendment request.
V skladu s členom 7(3) Uredbe (ES) št. 1831/2003 so bili navedenemu zahtevku priloženi zahtevani podatki in dokumenti ter ustrezni podatki v podporo navedeni zahtevi za spremembo.
The application concerns the authorisation of a new use of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, to be classified in the additive category ‘zootechnical additives’, the authorisation of a new use of that preparation via water for drinking for chickens for fattening and the modification of the terms of the current authorisation for chickens for fattening to allow simultaneous use with the additional coccidiostats: decoquinate, narasin, nicarbazin or narasin/nicarbazin, and to remove the limit for the maximum content of that preparation in complete feedingstuff.
Zahtevek zadeva dovoljenje za novo uporabo pripravka iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913 kot krmni dodatek za piščance za nesnice in manjše vrste perutnine, razen nesnic, ki se uvrsti v kategorijo dodatkov „zootehnični dodatki“, dovoljenje za novo uporabo navedenega pripravka v vodi, ki jo pijejo piščanci za pitanje, ter spremembo pogojev obstoječega dovoljenja za piščance za pitanje, da se omogoči sočasna uporaba z dodatnimi kokcidiostatiki (dekokvinat, narazin, nikarbazin ali narazin/nikarbazin) in odpravijo omejitve za najvišjo vsebnost navedenega pripravka v popolni krmni mešanici.
The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 544/2013.
Uporaba navedenega pripravka je bila z Izvedbeno uredbo (EU) št. 544/2013 dovoljena za deset let za piščance za pitanje.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 December 2014 [3] that, under the proposed conditions of use, the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 does not have an adverse effect on animal health, human health and the environment and has the potential to be efficacious when used in chickens reared for laying and minor poultry species other than laying.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojem mnenju z dne 9. decembra 2014 [3] navedla, da pod predlaganimi pogoji uporabe pripravek iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913 nima škodljivega vpliva na zdravje živali in ljudi ali na okolje ter da je lahko učinkovit, če se uporablja za piščance za nesnice in manjše vrste perutnine, razen nesnic.
The Authority also concluded that delivery of the additive via water for drinking is as safe for chickens for fattening as delivery via feed and that there would be no safety implications if the current maximum dose for chickens for fattening were withdrawn.
Agencija je tudi ugotovila, da je dodatek za piščance za pitanje enako varen, če se doda v vodo, ki jo pijejo, ali v njihovo krmo, in da varnost ne bi bila ogrožena, če bi bil ukinjen sedanji največji odmerek za piščance.
The conclusions on safety for chickens for fattening, as regards delivery via water for drinking and maximum dose, would also apply to chickens reared for laying and minor avian species.
Sklepi o varnosti za piščance za pitanje glede dodajanja pripravka v vodo, ki jo piščanci pijejo, in najvišjega odmerka, bi veljali tudi za piščance za nesnice in manjše aviarne vrste.
The Authority further concluded that the additive is compatible with the coccidiostats decoquinate, narasin, nicarbazin or narasin/nicarbazin.
Agencija je prav tako ugotovila, da je dodatek združljiv s kokcidiostatiki dekokvinat, narazin, nikarbazin ali narazin/nikarbazin.
It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Preverila je tudi poročilo o metodi analize krmnega dodatka v krmi, ki jo je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The assessment of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena pripravka iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913 je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
In order to allow for the use of coccidiostats compatible with the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 also for chickens for fattening and to allow for the same content of that preparation in complete feedingstuff for chickens for fattening as for chickens reared for laying and minor poultry species it is appropriate to amend Regulation (EU) No 544/2013.
Da se omogoči uporaba kokcidiostatikov, združljivih s pripravkom iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913, tudi za piščance za pitanje ter dovoli enaka vsebnost navedenega pripravka v popolni krmni mešanici tako za piščance za pitanje kot za piščance za nesnice in manjše vrste perutnine, je primerno spremeniti Izvedbeno uredbo (EU) št. 544/2013.
The Annex to Regulation (EU) No 544/2013 is amended as follows:
Priloga k Izvedbeni uredbi (EU) št. 544/2013 se spremeni:
In the eighth column, ‘Maximum content’, the text ‘1 × 109’ is deleted.
V osmem stolpcu „Najvišja vsebnost“ se črta besedilo „1 × 109“.
In the ninth column, ‘Other provisions’, paragraph 2 is replaced by the following:
V devetem stolpcu „Druge določbe“ se odstavek 2 nadomesti z naslednjim:
The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.’
Uporaba je dovoljena v krmi, ki vsebuje dovoljene kokcidiostatike: amonijev maduramicin, diklazuril, robenidin hidroklorid, dekokvinat, narazin, nikarbazin ali narazin/nikarbazin.“
Commission Implementing Regulation (EU) No 544/2013 of 14 June 2013 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH) (OJ L 163, 15.6.2013, p. 13).
Izvedbena uredba Komisije (EU) št. 544/2013 z dne 14. junija 2013 o izdaji dovoljenja za pripravek iz Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913 kot krmni dodatek za piščance za pitanje (imetnik dovoljenja Biomin GmbH) (UL L 163, 15.6.2013, str. 13).
EFSA Journal 2015; 13(1):3966.
EFSA Journal 2015;13(1):3966.
CFU [1]/kg of complete feedingstuff with a moisture content of 12 %
CFU [1] /kg popolne krmne mešanice z vsebnostjo vlage 12 %
CFU [1] l of water for drinking
CFU [1]/l vode za pitje
Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913
Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913.
Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive
Pripravek iz Bifidobacterium animalis ssp. animalis DSM 16284, ki vsebuje najmanj 3 × 109 CFU/g dodatka,
Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive
Lactobacillus salivarius ssp. salivarius DSM 16351, ki vsebuje najmanj 1 × 109 CFU/g dodatka, in
Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive
Enterococcus faecium DSM 21913, ki vsebuje najmanj 6 × 109 CFU/g dodatka.
Solid preparation (ratio 3:1:6)
Trdni pripravek (razmerje 3: 1: 6).
Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913
Žive celice Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 in Enterococcus faecium DSM 21913.
Analytical method [2]For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)
Analitska metoda [2]Za štetje: Bifidobacterium animalis ssp. animalis DSM 16284: metoda razmaza na plošči EN 15785.
Chickens reared for laying, minor poultry species other than laying
Lactobacillus salivarius ssp. salivarius DSM 16351: metoda razmaza na plošči EN 15787.
5 × 107
Enterococcus faecium DSM 21913 metoda razmaza na plošči EN 15788.
In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
Za identifikacijo: gelska elektroforeza v utripajočem polju (PFGE).
The use is permitted in feed containing the following coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.
Piščanci za nesnice, manjše vrste perutnine, razen nesnic.
For safety: breathing protection, glasses and gloves shall be used during handling.
5 × 107
The additive may be used also via water for drinking.
V navodilih za uporabo dodatka in premiksa je treba navesti temperaturo skladiščenja, rok trajanja in obstojnost pri peletiranju.
For use of the additive in water for drinking the homogeneous dispersion of the additive shall be ensured.
Uporaba je dovoljena v krmi, ki vsebuje naslednje kokcidiostatike: amonijev maduramicin, diklazuril, robenidin hidroklorid, dekokvinat, narazin, nikarbazin ali narazin/nikarbazin.
The simultaneous use with antibiotic shall be avoided.
Zaradi varnosti je treba pri ravnanju uporabljati zaščito za dihala, zaščitna očala in rokavice.
29 July 2025
Dodatek se lahko uporablja tudi v vodi za pitje.
PART B
Pri uporabi dodatka v vodi za pitje je treba zagotoviti njegovo homogeno razpršenost.
CFU [3]/l of water for drinking
Prepreči se sočasna uporaba z antibiotiki.
Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive
29. julij 2025
Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive
DEL B
Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive
CFU [3]/l vode za pitje
Analytical method [4]For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)
Pripravek iz Bifidobacterium animalis ssp. animalis DSM 16284, ki vsebuje najmanj 3 × 109 CFU/g dodatka,
Chickens for fattening
Lactobacillus salivarius ssp. salivarius DSM 16351, ki vsebuje najmanj 1 × 109 CFU/g dodatka, in
The water for drinking containing the additive may be used simultaneously with feed containing the following permitted coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.
Enterococcus faecium DSM 21913, ki vsebuje najmanj 6 × 109 CFU/g dodatka.
The homogeneous dispersion of the additive shall be ensured in the water for drinking.
Analitska metoda [4]Za štetje: Bifidobacterium animalis ssp. animalis DSM 16284: metoda razmaza na plošči EN 15785.
As total content of the mixture.
Lactobacillus salivarius ssp. salivarius DSM 16351: metoda razmaza na plošči EN 15787.
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Enterococcus faecium DSM 21913 metoda razmaza na plošči EN 15788.
Commission Implementing Regulation (EU) 2015/1106
Izvedbena uredba Komisije (EU) 2015/1106
amending Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 as regards the conditions of approval of the active substance isopyrazam
o spremembi izvedbenih uredb (EU) št. 540/2011 in (EU) št. 1037/2012 glede pogojev za odobritev aktivne snovi izopirazam
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular the second alternative of Article 21(3) thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS [1] ter zlasti druge alternative člena 21(3) Uredbe,
Commission Implementing Regulation (EU) No 1037/2012 [2] approved isopyrazam as active substance in accordance with Regulation (EC) No 1107/2009, provided that the applicant for approval, Syngenta Crop Protection AG (‘the applicant’), submits confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater, and listed it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 [3].
Z Izvedbeno uredbo Komisije (EU) št. 1037/2012 [2] je bil izopirazam v skladu z Uredbo (ES) št. 1107/2009 odobren kot aktivna snov pod pogojem, da vlagatelj vloge za odobritev Syngenta Crop Protection AG (v nadaljnjem besedilu: vlagatelj) predloži potrditvene informacije o vplivu metabolitov CSCD 459488 in CSCD 459489 na podtalnico, ter naveden na seznamu v delu B Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011 [3].
The confirmatory information was to be submitted to the Commission, the Member States and the European Food Safety Authority (‘the Authority’) by 31 March 2015.
Potrditvene informacije so bile Komisiji, državam članicam in Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) predložene do 31. marca 2015.
In February 2014, the applicant informed the Commission that it was expected that not all the confirmatory information required would be available by the deadline set out in Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012.
Vlagatelj je februarja 2014 obvestil Komisijo, da se pričakuje, da vse zahtevane potrditvene informacije ne bodo na voljo do roka iz izvedbenih uredb (EU) št. 540/2011 in (EU) št. 1037/2012.
The applicant stated that this delay was due to the need to develop appropriate testing protocols and submitted a working plan for the generation of that information.
Vlagatelj je navedel, da je ta zamuda nastala zaradi potrebe po pripravi ustreznih protokolov testiranja, in predložil delovni načrt za pridobitev navedenih informacij.
The United Kingdom as the rapporteur Member State for isopyrazam assessed the information submitted by the applicant and informed the Commission in September 2014 that it considered the request of the applicant to extend the deadline for the submission of confirmatory information to be reasoned and that the working plan submitted by the applicant is realistic and appropriate.
Združeno kraljestvo je kot država članica poročevalka za izopirazam ocenilo informacije, ki jih je predložil vlagatelj, ter septembra 2014 obvestilo Komisijo o svojem mnenju, da je prošnja vlagatelja za podaljšanje roka za predložitev potrditvenih informacij utemeljena, in o tem, da je delovni načrt, ki ga je predložil vlagatelj, uresničljiv in ustrezen.
Therefore, it appears that the request is justified in order to allow the applicant to generate the necessary data within a reasonable timeline.
Zato se zdi, da je prošnja upravičena iz razloga, da se vlagatelju omogoči pridobitev potrebnih podatkov v razumnem roku.
On 30 March 2015, the applicant submitted a summary document reporting the information generated so far and setting out a final working plan for the generation of the outstanding information.
Vlagatelj je 30. marca 2015 predložil dokument s povzetkom do takrat pridobljenih informacij in s končnim delovnim načrtom za pridobitev manjkajočih informacij.
It is therefore appropriate to amend the approval of isopyrazam and extend the deadline for the submission of confirmatory information until 31 July 2017.
Zato je primerno, da se odobritev izopirazama spremeni in da se rok za predložitev potrditvenih informacij podaljša do 31. julija 2017.
Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 should therefore be amended accordingly.
Izvedbeni uredbi (EU) št. 540/2011 in (EU) št. 1037/2012 bi bilo zato treba ustrezno spremeniti.