natgillin/translations-raw huggingface dataset:
EFSA Journal 2018; 16(3):5219.
Izvedbena uredba Komisije (EU) 2016/897 z dne 8. junija 2016 o izdaji dovoljenja za pripravek iz Bacillus subtilis (C-3102) (DSM 15544) kot krmni dodatek za kokoši nesnice in okrasne ribe (imetnik dovoljenja Asahi Calpis Wellness Co. Ltd.) in o spremembi uredb (ES) št. 1444/2006, (EU) št. 333/2010 in (EU) št. 184/2011, kar se tiče imetnika dovoljenja (UL L 152, 9.6.2016, str. 7).
ANNEX
Izvedbena uredba Komisije (EU) 2017/2312 z dne 13. decembra 2017 o izdaji dovoljenja za novo uporabo pripravka iz Bacillus subtilis C-3102 (DSM 15544) kot krmnega dodatka za svinje, sesne pujske in pse (imetnik dovoljenja Asahi Calpis Wellness Co. Ltd, ki ga zastopa Asahi Calpis Wellness Co. Ltd Europe Representative Office) (UL L 331, 14.12.2017, str. 41).
Identification number of the additive
EFSA Journal 2018;16(3):5219.
Asahi Calpis Wellness Co.
Kategorija zootehničnih dodatkov.
Ltd, represented in the European Union by Asahi Calpis Wellness Co.
Funkcionalna skupina: stabilizatorji mikroflore.
Additive composition
Ltd., ki ga v Evropski uniji zastopa Asahi Calpis Wellness Co.
Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g
Ltd.
Solid form
Europe Representative Office
Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)
Bacillus subtilis C-3102 (DSM 15544) z najnižjo vsebnostjo 1,0 × 1010 CFU/g
Analytical method
v trdni obliki
Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)
Lastnosti aktivne snovi
Identification: pulsed-field gel electrophoresis (PFGE).
žive spore (CFU) Bacillus subtilis C-3102 (DSM 15544)
Pigs for fattening
Analizna metoda
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
Za štetje: metoda razmaza na plošči z uporabo sojinega agarja s triptonom v vseh ciljnih matricah (EN 15784:2009).
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of their use.
Za identifikacijo: gelska elektroforeza v utripajočem polju (PFGE).
Commission Implementing Regulation (EU) 2018/1090
Izvedbena uredba Komisije (EU) 2018/1090
of 31 July 2018
z dne 31. julija 2018
concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) (holder of the authorisation Kaesler Nutrition GmbH)
o izdaji dovoljenja za pripravek iz endo-1,4-beta-ksilanaze in endo-1,3(4)-beta-glukanaze, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469), kot krmni dodatek za pitovne piščance, piščance za nesnice, pitovne purane, vse aviarne vrste za nesnice ali za razplod, odstavljene pujske in manj pomembne vrste prašičev (odstavljenih) (imetnik dovoljenja Kaesler Nutrition GmbH)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469).
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za pripravek iz endo-1,4-beta-ksilanaze in endo-1,3(4)-beta-glukanaze, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469).
The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and all porcine species (weaned) to be classified in the additive category ‘zootechnical additives’.
Zahtevek zadeva dovoljenje za pripravek iz endo-1,4-beta-ksilanaze in endo-1,3(4)-beta-glukanaze, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469), kot krmni dodatek za pitovne piščance, piščance za nesnice, pitovne purane, vse aviarne vrste za nesnice ali za razplod, odstavljene pujske in vse vrste prašičev (odstavljenih) ter njegovo uvrstitev v kategorijo dodatkov „zootehnični dodatki“.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 November 2017 that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) does not have an adverse effect on animal health, human health or the environment.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 30. novembra 2017 navedla, da pripravek iz endo-1,4-beta-ksilanaze in endo-1,3(4)-beta-glukanaze, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469), pod predlaganimi pogoji uporabe nima škodljivega učinka na zdravje živali in ljudi ali na okolje.
It was concluded that the additive has a potential to improve zootechnical parameters in chickens for fattening, turkeys for fattening, and weaned piglets.
Prav tako je navedla, da dodatek lahko izboljša proizvodne lastnosti pri pitovnih piščancih, pitovnih puranih in odstavljenih pujskih.
This conclusion can be extended to chickens reared for laying and turkeys reared for breeding.
Ta ugotovitev se lahko razširi na piščance za nesnice in purane za razplod.
The Authority also concluded that the effects of the additive on turkeys for fattening and on weaned piglets can be extrapolated respectively to all avian species up to the reared for laying and to weaned piglets of all porcine species.
Agencija je tudi navedla, da se učinki dodatka na pitovne purane in odstavljene pujske lahko ekstrapolirajo na vse aviarne vrste za nesnice in odstavljene pujske vseh vrst prašičev.
HAS ADOPTED THIS REGULATION:
Pripravek iz Priloge, ki spada v kategorijo dodatkov „zootehnični dodatki“ in funkcionalno skupino „pospeševalci prebavljivosti“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 31. julija 2018
Done at Brussels, 31 July 2018.
Predsednik
The President
EFSA Journal 2017;15(12):5097.
EFSA Journal 2017; 15(12):5097.
Identifikacijska številka dodatka
Name of the holder of authorisation
Sestava, kemijska formula, opis, analizna metoda
Category of zootechnical additives.
endo-1,4-beta-ksilanaza
Endo-1,3(4)-beta-glucanase
Pripravek iz endo-1,4-beta-ksilanaze in endo-1,3(4)-beta-glukanaze, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469), z najmanjšo aktivnostjo:
Additive composition
25000 LXU/g in 2200 LGU/g.
Preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) having a minimum activity of:
V trdni in tekoči obliki.
25000 LXU/g and 2200 LGU/g
Lastnosti aktivne snovi
Solid and liquid form.
endo-1,4-beta-ksilanaza in endo-1,3(4)-beta-glukanaza, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469)
endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469)
Za določanje ksilanaze v krmnem dodatku, premiksih in krmi:
Analytical method
kolorimetrična metoda, ki temelji na kvantitativnem določanju vodotopnih obarvanih delcev, ki nastanejo z delovanjem endo-1,4-β-ksilanaze na navzkrižno vezan arabinoksilan iz pšenice.
Determination in the feed additive, premixtures and feedingstuffs of xylanase
Za določanje endo-1,3(4)-beta-glukanaze v krmnem dodatku, premiksih in krmi:
colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan.
kolorimetrična metoda, ki temelji na kvantitativnem določanju vodotopnih obarvanih delcev, ki nastanejo z delovanjem endo-1,3(4)-beta-glukanaze na navzkrižno vezan azoglukan iz ječmena.
Determination in the feed additive, premixtures and feedingstuffs of endo-1,3(4)-beta-glucanase:
pitovni piščanci
colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,3(4)-beta-glucanase on cross-linked azo-barley-glucan.
piščanci za nesnice
4250 LXU
Nosilci dejavnosti poslovanja s krmo zaradi morebitnih tveganj, ki izhajajo iz uporabe dodatka in premiksov, za uporabnike določijo postopke varnega ravnanja in organizacijske ukrepe.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
Kadar navedenih tveganj s takimi postopki in ukrepi ni mogoče odpraviti ali čim bolj zmanjšati, se dodatek in premiksi uporabljajo z osebno zaščitno opremo.
For use in weaned piglets up to 35 kg of body weight.
pitovni purani
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks from their use.
vse aviarne vrste za nesnice ali za razplod, razen piščancev za nesnice
Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.
pujski (odstavljeni)
Turkeys for fattening
manj pomembne vrste prašičev (odstavljenih)
1400 LXU
1 LGU je količina encima, ki sprosti 1 mikromol reduktivnih sladkorjev (ekvivalentov glukoze) iz ječmenovega glukana na minuto pri pH 5,5 in 50 °C.
Piglets (weaned)
Podrobnosti o analiznih metodah so na voljo na naslovu referenčnega laboratorija: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
Minor porcine species (weaned)
Ocena pripravka iz endo-1,4-beta-ksilanaze in endo-1,3(4)-beta-glukanaze, ki ju proizvajata Komagataella pastoris (CBS 25376) in Komagataella pastoris (CBS 26469), kaže, da so pogoji za izdajo dovoljenja iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
1 LXU is the amount of enzyme which releases one micromole of reducing sugars equivalents (as xylose) from birch xylan per minute at pH 5,5 and 50 °C.
Zato bi bilo treba dovoliti uporabo navedenega pripravka, kakor je opredeljena v Prilogi k tej uredbi.
1 LGU is the amount of enzyme which releases one micromole of reducing sugars equivalents (as glucose) from barley glucan per minute at pH 5,5 and 50 °C.
ES 3.2.1.8
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
ES 3.2.1.6
Regulation (EU) 2018/1091 of the European Parliament and of the Council
Uredba (EU) 2018/1091 Evropskega parlamenta in Sveta
on integrated farm statistics and repealing Regulations (EC) No 1166/2008 and (EU) No 1337/2011
o integrirani statistiki na ravni kmetij ter razveljavitvi uredb (ES) št. 1166/2008 in (EU) št. 1337/2011
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 338 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 338 Pogodbe,
That Regulation should therefore be repealed.
Takšna baza znanja je potrebna tudi, da se oceni vpliv teh politik na žensko delovno silo na kmetijskih gospodarstvih.
The programme of European surveys on the structure of agricultural holdings, which has been carried out in the Union since 1966, should be continued in order to examine the trends in the structure of agricultural holdings at the Union level and to provide the statistical knowledge base necessary for the design, implementation, monitoring, evaluation and review of related policies, in particular the common agricultural policy (CAP), including rural development measures, as well as environmental, climate change adaptation and mitigation and land use policies of the Union and some Sustainable Development Goals (SDGs).
Cilj zbiranja statističnih podatkov, zlasti o strukturi kmetij, bi moral poleg drugih ciljev biti zagotavljanje posodobljenih podatkov za postopek odločanja glede na prihodnje reforme SKP.
Such a knowledge base is also required in order to estimate the impact of those policies on the female workforce on agricultural holdings.
Uredba (ES) št. 223/2009 Evropskega parlamenta in Sveta določa okvir za razvoj, pripravo in izkazovanje evropske statistike na podlagi skupnih statističnih načel.
An international evaluation of agricultural statistics led to setting up the Food and Agriculture Organization's (FAO) Global Strategy to Improve Agricultural and Rural Statistics that was endorsed by the United Nations Statistics Committee (UNSC) in 2010.
Za naslednje desetletje bi bilo treba vzpostaviti večnamenski statistični program za kmetijska gospodarstva, ki bo zagotovil okvir za harmonizirano, primerljivo in skladno statistiko.
European agricultural statistics should, where appropriate, follow the recommendations of the Global Strategy to Improve Agricultural and Rural Statistics, as well as those of the FAO World Programme for the Census of Agriculture 2020.
Ta statistika bi morala biti prilagojena potrebam politik.
Regulation (EC) No 223/2009 of the European Parliament and of the Council provides for a framework for the development, production and dissemination of European statistics, based on common statistical principles.
Strategija za kmetijsko statistiko za 2020 in pozneje, ki jo je novembra 2015 oblikoval Odbor za evropski statistični sistem (ESSC), predvideva sprejetje dveh okvirnih uredb, ki bi zajemali vse vidike kmetijske statistike, razen ekonomskih računov za kmetijstvo.
It establishes quality criteria, and refers to the need to minimise the response burden on survey respondents and to contribute to the more general objective of a reduction of administrative burdens.
Ena od teh okvirnih uredb je ta uredba.
A multipurpose statistical programme on agricultural holdings should be set up for the next decade to provide the framework for harmonised, comparable and coherent statistics.
Zaradi uskladitve in primerljivosti informacij o strukturi kmetijskih gospodarstev ter za izpolnitev sedanjih potreb enotne skupne ureditve trgov ter zlasti sektorja sadja in vina bi bilo treba Uredbo (EU) št. 1337/2011 Evropskega parlamenta in Sveta od leta 2023 naprej povezati s strukturnimi informacijami na ravni kmetijskih gospodarstev in jo nadomestiti s to uredbo.
Those statistics should be targeted towards policy needs.
Navedeno uredbo je zato treba razveljaviti.
The Strategy for Agricultural Statistics for 2020 and beyond, set up by the European Statistical System Committee (ESSC) in November 2015, envisages the adoption of two framework Regulations covering all aspects of agricultural statistics, with the exception of the Economic Accounts for Agriculture.
Primerljiva statistika iz vseh držav članic o strukturi kmetijskih gospodarstev je pomembna za določanje razvoja SKP.
This Regulation is one of those framework Regulations.
Zato bi bilo treba za spremenljivke v čim večji meri uporabiti standardne klasifikacije in skupne opredelitve.
For the purposes of harmonisation and comparability of information on the structure of agricultural holdings and in order to meet the current needs of the Single Common Market Organisation and in particular the fruit and wine sector, Regulation (EU) No 1337/2011 of the European Parliament and of the Council should be integrated with the structural information at the level of agricultural holdings from 2023 onwards and replaced by this Regulation.
Statistični podatki o kmetijskih gospodarstvih omogočajo navzkrižno tabeliranje osnovnih podatkov in podatkov o modulih, s čimer omogočajo pridobivanje informacij na osnovi spremenljivk, kot so spol upravitelja kmetijskega gospodarstva, njegova starost, lastniška struktura in velikost kmetijskega gospodarstva ter izvajanje okoljskih ukrepov.
It is therefore necessary to repeal that Regulation.
Razčlenitev rezultatov bo mogoča za merila, vključena v osnovnih podatkih, in za kombinacije meril.
Comparable statistics from all Member States on the structure of agricultural holdings are important to determine the development of the CAP.
Zbiranje podatkov o letu rojstva, o letu uvrstitve v kategorijo upravitelja kmetijskega gospodarstva in o spolu bi lahko zagotovilo podatke za pripravo ukrepov v zvezi z menjavo generacij in vidiki, povezanimi s spolom.
Therefore standard classifications and common definitions should be used insofar as possible for variables.
Za posodobitev osnovnih registrov kmetijskih gospodarstev in preostalih informacij, potrebnih za stratifikacijo vzorcev, in tudi zaradi drugih razlogov bi bilo treba v Uniji vsaj vsakih deset let opraviti popis kmetijskih gospodarstev.
The statistical data records relating to agricultural holdings enable core and module data to be cross-tabulated, therefore allowing for information to be retrieved based on variables such as the gender of the manager of the agricultural holding, that manager's age, the ownership structure and size of the agricultural holding and the uptake of environmental measures.
Zadnji popis je bil opravljen v letih 2009/2010.
A disaggregation of results will be possible for the criteria included in the core data and for combinations of criteria.
Države članice, v katerih se obdobja dela na terenu za referenčno leto raziskovanja 2020 prekrivajo z načrtovanim delom za 10-letni popis prebivalstva, bi morale imeti možnost, da raziskovanje v kmetijstvu izvedejo leto prej, da bi se izognile težkemu bremenu, ki bi ga predstavljalo izvajanje dveh obsežnih zbiranj podatkov hkrati.
The collection of information on year of birth, year when classified as manager of the agricultural holding and gender could provide data for the development of actions in respect of generational renewal and gender-related aspects.
Da bi preprečili nepotrebno obremenjevanje kmetijskih gospodarstev in nacionalnih uprav, bi bilo treba določiti pragove.
Amongst other reasons, for the purposes of updating the basic registers of agricultural holdings and the rest of the information required for the stratification of samples, a census of agricultural holdings should be carried out in the Union at least every 10 years.
Da bi lahko ustrezno analizirali strukturo evropskega kmetijstva, bi morali statistično zajeti 98 % kmetijske površine v uporabi in živine na kmetijah.
The most recent census took place in 2009/2010.
To pomeni, da so pragovi iz te uredbe v nekaterih državah članicah previsoki.
Member States in which the periods of fieldwork for the survey reference year 2020 overlap with the work planned for the 10-year population census should have the possibility to bring the farming survey forward a year so as to avoid the heavy burden of conducting two major data collections at the same time.
Vendar so kmetijska gospodarstva, ki ne dosegajo teh pragov, tako majhna, da je za oceno njihove strukture in učinka na proizvodnjo dovolj, da se vzorčno zbiranje podatkov izvede enkrat na desetletje, s čimer se zmanjšajo stroški in bremena, hkrati pa je še vedno mogoče zasnovati učinkovit ukrep politik za podporo in ohranjanje majhnih kmetijskih struktur.
In order to avoid placing an unnecessary burden on agricultural holdings and national administrations, thresholds should be established.
Integrirana statistika na ravni kmetij bi morala zajeti območja, ki se uporabljajo za kmetijsko proizvodnjo, vključno z zemljišči, ki jih uporabljata dve kmetijski gospodarstvi ali več, saj se zanje uporabljajo skupne pravice.
Properly analysing the structure of European agriculture requires that 98 % of the utilised agricultural area and the livestock on farms should be covered by the statistics.
Treba je pridobiti informacije o pripadnosti kmetijskega gospodarstva skupini podjetij, katere subjekti so pod nadzorom matičnega subjekta.
In some Member States, this means that the thresholds listed in this Regulation are too high.
Da bi zmanjšali breme za dajalce podatkov, bi morali imeti nacionalni statistični uradi in drugi nacionalni organi v skladu s členom 17a Uredbe (ES) št. 223/2009 dostop do administrativnih podatkov, če te podatke potrebujejo za razvoj, pripravo in izkazovanje evropske statistike.
However, the agricultural holdings below those thresholds are so small that a sample data collection to be carried out once per decade is sufficient to allow the estimation of their structure and the impact on production, resulting in the reduction of costs and burdens while still enabling the design of effective policy action to support and maintain small farming structures.
Države članice ali pristojni nacionalni organi bi si morali prizadevati za posodobitev načinov za zbiranje podatkov o kmetijskih gospodarstvih, kolikor je to mogoče.
The areas used for agricultural production should be covered by integrated farm statistics, including the land used by two or more agricultural holdings because common rights apply.
V zvezi s tem bi bilo treba spodbujati uporabo digitalnih rešitev.
It is necessary to receive information about the affiliation of an agricultural holding to a group of enterprises, the entities of which are controlled by a parent entity.
Zaradi prilagodljivosti evropskega statističnega sistema za kmetijstvo ter poenostavitve in posodobitve kmetijske statistike bi bilo treba spremenljivke, ki jih je treba zbrati, umestiti v različne zbirne skupine (osnovni podatki in moduli), ki se razlikujejo v pogostosti ali reprezentativnosti ali obeh vidikih.
In order to reduce the burden on respondents, the National Statistical Institutes (NSIs) and other national authorities should have access to administrative data, to the extent that those data are necessary for the development, production and dissemination of European statistics, in accordance with Article 17a of Regulation (EC) No 223/2009.
Breme in stroške poročanja je mogoče še zmanjšati, če se ponovno uporabijo podatki iz leta neposredno pred referenčnim letom ali takoj po njem.
Member States or responsible national authorities should endeavour to modernise data collection modes on agricultural holdings insofar as possible.
To zlasti velja glede vidikov, pri katerih od enega leta do drugega ni pričakovati velikih sprememb.
The use of digital solutions in that regard should be promoted.
Zaradi prožnosti in da bi zmanjšali breme za dajalce podatkov, nacionalnih statističnih uradov in drugih nacionalnih organov, lahko države članice uporabijo statistična raziskovanja, administrativne evidence in katere koli druge vire, metode ali inovativne pristope, vključno z znanstveno utemeljenimi in dobro dokumentiranimi metodami, kot so imputacija, ocena in modeliranje.
For the purposes of flexibility for the European agricultural statistical system, and for the simplification and modernisation of agricultural statistics, the variables to be collected should be allocated to different collection groups (core data and modules) varying in frequency or representativeness, or both.
Izboljšati bi bilo treba zbiranje informacij o uporabi hranilnih snovi in vode ter metodah kmetijske proizvodnje, ki se uporabljajo na kmetijskih gospodarstvih, da bi zagotovili dodatno statistiko za razvoj kmetijsko-okoljske politike in izboljšali kakovost kmetijsko-okoljskih kazalnikov.
The response burden and costs can be further reduced by reusing data from the year directly preceding or following the reference year.
Za geokodiranje kmetijskih gospodarstev bi bilo treba uporabiti temo statističnih okolišev v skladu s Prilogo III k Direktivi 2007/2/ES Evropskega parlamenta in Sveta.
This would be particularly relevant for aspects where no large changes are expected from one year to the next.
Komisija mora spoštovati zaupnost podatkov, poslanih v skladu z Uredbo (ES) št. 223/2009.