natgillin/translations-raw huggingface dataset:
Furthermore, the existing authorisation of the preparation of Enterococcus faecium CECT 4515 for chickens for fattening in Implementing Regulation (EU) No 887/2011 should be supplemented by a new use in water for drinking by way of an amendment to that Implementing Regulation.
Poleg tega bi bilo treba obstoječe dovoljenje za pripravek Enterococcus faecium CECT 4515 za piščance za pitanje iz Izvedbene uredbe (EU) št. 887/2011 dopolniti z novo uporabo v vodi za pitje s spremembo navedene izvedbene uredbe.
The preparation specified in Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Pripravek iz Priloge I, ki spada v kategorijo dodatkov „zootehnični dodatki“ in funkcionalno skupino „stabilizatorji mikroflore“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
Amendment to Regulation (EC) No 2036/2005
Sprememba Uredbe (ES) št. 2036/2005
In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
V Prilogi I k Uredbi (ES) št. 2036/2005 se črta vnos E 1713 za Enterococcus faecium CECT 4515.
Amendment to Regulation (EU) No 887/2011
Sprememba Uredbe (EU) št. 887/2011
The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
Priloga k Uredbi (EU) št. 887/2011 se nadomesti s Prilogo II k tej uredbi.
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 28 December 2017 in accordance with the rules applicable before 28 June 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
Pripravek iz Priloge in krma, ki vsebuje navedeni pripravek, proizvedena in označena pred 28. decembrom 2017 v skladu s pravili, ki se uporabljajo pred 28. junijem 2017, se lahko še naprej dajeta na trg in uporabljata do porabe obstoječih zalog.
Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (OJ L 328, 15.12.2005, p. 13).
Uredba Komisije (ES) št. 2036/2005 z dne 14. decembra 2005 o trajnih dovoljenjih za nekatere dodatke v krmnih mešanicah in začasnem dovoljenju za novo uporabo nekaterih že dovoljenih dodatkov v krmnih mešanicah (UL L 328, 15.12.2005, str. 13).
Commission Implementing Regulation (EU) No 887/2011 of 5 September 2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Evonik Nutrition & Care GmbH) (OJ L 229, 6.9.2011, p. 7).
Izvedbena uredba Komisije (EU) št. 887/2011 z dne 5. septembra 2011 o izdaji dovoljenja za pripravek Enterococcus faecium CECT 4515 kot krmni dodatek za piščance za pitanje (imetnik dovoljenja je družba Evonik Nutrition & Care GmbH) (UL L 229, 6.9.2011, str. 7).
Maximum content
CFU/kg popolne krmne mešanice z vsebnostjo vlage 12 %
Other provisions
CFU/l vode za pitje
End of period of authorisation
Kategorija: zootehnični dodatki.
CFU/kg of complete feedingstuff with a moisture content of 12 %
Funkcionalna skupina: stabilizatorji mikroflore
CFU/l of water for drinking
Sestava dodatka
Category of zootechnical additives.
pripravek iz Enterococcus faecium CECT 4515 z najnižjo vsebnostjo 1 × 109 CFU/g dodatka v trdni obliki
Functional group: gut flora stabilisers
Lastnosti aktivne snovi
Additive composition
Analitska metoda [1]Metoda štetja: metoda razmaza na plošči z uporabo žolčnega eskulin azidnega agarja (EN 15788)
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid form
Identifikacija: gelska elektroforeza v utripajočem polju (PFGE)
Characterisation of the active substance
odstavljeni pujski
Viable cells of Enterococcus faecium CECT 4515
Dodatek se lahko uporablja v vodi za pitje.
Analytical method [1]Enumeration: spread plate method using bile esculin azide agar (EN 15788)
V navodilih za uporabo dodatka in premiksov je treba navesti obstojnost v vodi za pitje.
Identification: Pulsed-Field Gel Electrophoresis (PFGE)
V navodilih za uporabo dodatka in premiksov je treba navesti pogoje skladiščenja in obstojnost pri toplotni obdelavi.
Weaned piglets
Pri uporabi dodatka v vodi za pitje je treba zagotoviti njegovo homogeno razpršenost.
The additive may be used in water for drinking.
Za uporabo pri odstavljenih pujskih do 35 kg telesne teže.
In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
Nosilci dejavnosti poslovanja s krmo zaradi morebitnih tveganj za uporabnike dodatka in premiksov pri ravnanju z njimi 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, vključno z zaščito za dihala in kožo.
For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.
28. junij 2027
For use in weaned piglets up to 35 kg of body weight.
Podrobnosti o analitskih metodah so na voljo na naslednjem naslovu referenčnega laboratorija za krmne dodatke: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use.
PRILOGA II
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, including breathing protection and skin protection.
PRILOGA
28 June 2027
pripravek iz Enterococcus faecium CECT 4515 z najnižjo vsebnostjo 1 × 109 CFU/g dodatka
Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
v trdni obliki
ANNEX II
Analitska metoda [1]Metoda štetja: metoda razmaza na plošči z uporabo žolčnega eskulin azidnega agarja (EN 15788)
ANNEX
piščanci za pitanje
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive
Uporaba je skladna v krmi, ki vsebuje enega od naslednjih odobrenih kokcidiostatikov: natrijev monenzin, diklazuril, nikarbazin, dekokvinat, robenidin hidroklorid, natrijev semduramicin, narazin, natrijev salinomicin, natrijev lasalocid A, narazin/nikarbazin ali amonijev maduramicin.
Solid forms
26. september 2021
Analytical method [1]Enumeration: spread plate method using bile esculin azide agar (EN 15788)
v trdni obliki
Chickens for fattening
Analitska metoda [2]Metoda štetja: metoda razmaza na plošči z uporabo žolčnega eskulin azidnega agarja (EN 15788)
The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.
Identifikacija: gelska elektroforeza v utripajočem polju (PFGE)
26 September 2021
Podrobnosti o analitskih metodah so na voljo na naslednjem naslovu referenčnega laboratorija za krmne dodatke: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
Commission Implementing Regulation (EU) 2017/962
Izvedbena uredba Komisije (EU) 2017/962
suspending the authorisation of ethoxyquin as a feed additive for all animal species and categories
o začasnem preklicu dovoljenja za etoksikvin kot krmni dodatek za vse živalske vrste in kategorije
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting, denying or suspending such authorisation.
Uredba (ES) št. 1831/2003 določa izdajo dovoljenj za dodatke, ki se uporabljajo v prehrani živali, ter razloge in postopke za izdajo, zavrnitev ali začasen preklic takih dovoljenj.
The additive ethoxyquin was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use for all animal species and categories.
Etoksikvin je bil v skladu z Direktivo 70/524/EGS dovoljen kot krmni dodatek za vse živalske vrste in kategorije brez časovne omejitve.
The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
Dodatek je bil naknadno vpisan v register krmnih dodatkov kot obstoječ proizvod v skladu s členom 10(1) Uredbe (ES) št. 1831/2003.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted on 21 September 2010 for the authorisation of ethoxyquin as a feed additive for all animal species, requesting the additive to be classified in the category ‘technological additives’.
V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in v povezavi s členom 7 navedene uredbe je bil 21. septembra 2010 vložen zahtevek za dovoljenje za etoksikvin kot krmni dodatek za vse živalske vrste in njegovo uvrstitev v kategorijo „tehnološki dodatki“.
The European Food Safety Authority (‘the Authority’) stated in its opinion of 21 October 2015 [3] that the assessment of the particulars and documents submitted by the applicant makes it impossible to conclude on the safety of the additive ethoxyquin for any target animals, for consumers and for the environment.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z 21. oktobra 2015 [3] navedla, da na podlagi ocene zahtevanih podatkov in dokumentov, ki jih je predložil vložnik, ni mogoče sklepati o varnosti etoksikvina za katere koli ciljne živali, potrošnike in okolje.
This is due to an overall lack of data submitted to assess the exposure and the safety of ethoxyquin for animals, consumers and the environment.
Razlog za to je splošno pomanjkanje predloženih podatkov, na podlagi katerih bi lahko ocenili izpostavljenost in varnost etoksikvina za živali, potrošnike in okolje.
In particular, no conclusion is possible on the absence of genotoxicity of one of the metabolites of the additive ethoxyquin, ethoxyquin quinone imine.
Zlasti ni mogoče sklepati o odsotnosti genotoksičnosti enega od metabolitov etoksikvina, in sicer etoksikvin kinon imina.
In addition, p-phenetidine, an impurity of the additive ethoxyquin, is recognised as a possible mutagen.
Poleg tega je p-fenetidin, nečistota etoksikvina, prepoznan kot možna mutagena snov.
The Authority considered the additive ethoxyquin as a potent antioxidant in feed but efficacy at the proposed use level, which has been reduced as compared with the currently authorised maximum content in feed, could not be confirmed by the submitted data.
Agencija je etoksikvin štela za močan antioksidant v krmi, vendar na podlagi predloženih podatkov ni mogla potrditi njegove učinkovitosti na predlagani ravni uporabe, ki je bila v primerjavi s trenutno dovoljeno največjo vsebnostjo v krmi zmanjšana.
The Authority 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.
Potrdila je tudi poročilo o analitski metodi krmnega dodatka, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
Consequently, it has not been established that the additive does not have an adverse effect on animal health, human health or the environment when used under the proposed conditions.
Zato ni bilo ugotovljeno, da navedeni dodatek pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali na okolje.
The existing authorisation of the additive ethoxyquin therefore no longer meets the conditions set out by Article 5 of Regulation (EC) No 1831/2003.
Obstoječe dovoljenje za etoksikvin zato ne izpolnjuje več pogojev iz člena 5 Uredbe (ES) št. 1831/2003.
It is possible that supplementary data concerning the safety of use and the efficacy of the additive ethoxyquin bring new elements that would allow a re-consideration of the assessment carried out for that additive.
Dodatni podatki v zvezi z varnostjo uporabe in učinkovitostjo etoksikvina bi lahko razkrili nove elemente, ki bi omogočili ponovno proučitev ocene navedenega dodatka.
In this respect, the applicant for the authorisation of the additive ethoxyquin argues that additional studies may be performed in order to demonstrate the safety and efficacy of the additive.
V zvezi s tem vložnik zahtevka za dovoljenje etoksikvina trdi, da bi se lahko opravile dodatne študije, ki bi dokazale varnost in učinkovitost dodatka.
The prioritisation in the process of the planned data generation is based on the level of importance of the issues identified in the Authority's opinion.
V skladu s členom 13(2) Uredbe (ES) št 1831/2003 bi bilo zato treba do predložitve in proučitve dodatnih podatkov dovoljenje za etoksikvin začasno preklicati.
In addition, as the presence in the additive ethoxyquin of the impurity p-phenetidine results from the manufacturing process of the additive, the applicant committed itself to take steps in order to reduce progressively the content of that impurity in the additive to the level of 2,5 ppm p-phenetidine in ethoxyquin by June 2017.
V vsakem primeru pa bi bilo treba opraviti pregled ukrepa začasnega preklica, če Agencija v postopku predložitve in proučitve dodatnih podatkov sprejme negativno mnenje glede varnosti ali učinkovitosti etoksikvina.
For that purpose, an appropriate method of analysis for the detection of p-phenetidine in the additive ethoxyquin and in feed containing the additive should be submitted by the applicant and accepted by the Authority on the basis of a report of the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Ker bi nadaljnja uporaba etoksikvina lahko povzročila tveganje za zdravje ljudi in živali ali za okolje, bi bilo treba dodatek in krmo, ki ga vsebuje, čimprej umakniti s trga.
In accordance with Article 13(2) of Regulation (EC) No 1831/2003, the authorisation of the additive ethoxyquin should therefore be suspended, pending the submission and assessment of the supplementary data.
Iz praktičnih razlogov bi moralo biti na voljo omejeno prehodno obdobje za umik zadevnih proizvodov s trga, da bi nosilci dejavnosti lahko ustrezno izpolnili obveznost umika.
The suspension measure should be reviewed after due assessment of those data by the Authority.
Posamična krmila morskega izvora, ki vsebujejo visoke ravni maščobnih kislin, so zelo občutljiva na oksidacijo in visoke temperature ter jih je treba stabilizirati z antioksidantom, zlasti če se dolgo časa prevažajo ali shranjujejo.
In any event, a review of the suspension measure should be adopted where, during the process of the submission and assessment of the supplementary data, the Authority adopts a non-favourable opinion on the safety or efficacy of the additive ethoxyquin.
Zaradi tega visokega tveganja oksidacije se etoksikvin na široko uporablja za učinkovito zaščito zadevnih posamičnih krmil.
Since further use of the additive ethoxyquin might cause a risk to human, animal health and the environment, the additive and feed containing it should be withdrawn from the market as soon as possible.
Navedena posamična krmila, zlasti ribja moka in ribje olje, imajo visoko prehransko vrednost in vsebujejo veliko koncentracijo lahko prebavljivih beljakovin, ki so potrebne v prehrani živali iz akvakulture in mladih živali, uporabljajo pa s tudi za druge živalske vrste, zlasti prašiče in perutnino.
For practical reasons, however, a limited transitional period should be allowed for the withdrawal from the market of the products concerned in order to enable operators to comply properly with the withdrawal obligation.
Poleg tega je prepoznano, da visoka vsebnost polinenasičenih maščobnih kislin v navedenih posamičnih krmilih, ki se prenesejo v proizvode živalskega izvora, prinaša koristi za zdravje živine in ljudi, ki uživajo proizvode živalskega izvora.
Feed materials from marine origin, which contain high levels of fatty acids, are very sensitive to oxidation and high temperature and need to be stabilised by an antioxidant, in particular where the feed materials are subject to a long shipping or storage period.
Zato bi takojšen umik etoksikvina s trga lahko imel negativne posledice na zdravje in dobrobit živali, poleg tega pa ne bi bilo mogoče zadostiti posebnim prehranskim zahtevam živali, dokler ne bi bili na voljo primerni nadomestki.
Due to that high risk of oxidation, ethoxyquin is widely used to protect the feed materials concerned in an effective manner.
Etoksikvin se na široko uporablja tudi kot sestavina nekaterih pripravkov krmnih dodatkov, ki vsebujejo aktivno snov, posebej občutljivo na oksidacijo in segrevanje, in jih je treba stabilizirati z antioksidantom, da ohranijo svoje lastnosti.
Those feed materials, in particular fish meal and fish oil, are of high nutritional value and contain an important concentration of easily digestible proteins, which are required in aquaculture animals' and in young animals' diet, but are also used for other animal species, especially for pigs and poultry.
Navedeni krmni dodatki se nahajajo v pripravkih nekaterih esencialnih vitaminov, karetonoidov in barvil, ki so lipidotopni in jih je treba med proizvodnim postopkom, shranjevanjem in prevozom pripravkov in krme, ki jih vsebujejo, zaščititi, dokler niso dostavljeni živalim.
In addition, the high content in those feed materials of poly-unsaturated fatty acids, which are transferred to animal products, is recognised to provide health benefits to livestock and to the consumers of animal products.
Zaradi široke uporabe etoksikvina v navedenih pripravkih krmnih dodatkov bi takojšnji umik etoksikvina s trga negativno vplival na zdravje in dobrobit živali, saj bi bilo v krmi za več živalskih vrst, tako tistih, ki so namenjene za proizvodnjo hrane, kot tistih, ki niso, premalo esencialnih mikrohranil.
Therefore, an immediate withdrawal from the market of ethoxyquin could lead to negative consequences for animal health and welfare and to an inability to meet the animals' specific nutritional requirements until suitable alternatives are in place.
Poleg tega bi pomanjkanje zadevnih pripravkov krmnih dodatkov v Uniji lahko vodilo do nižje učinkovitosti krme in slabše proizvodnosti živine, pa tudi do nezmožnosti izpolnjevanja tržnih specifikacij za nekatere proizvode živalskega izvora.
Ethoxyquin is also widely used as constituent of certain feed additives preparations containing an active substance which is particularly sensitive to oxidation and heat treatment and needs to be stabilised by an antioxidant in order to maintain its properties.
Zdi se, da etoksikvina ne bi bilo mogoče takoj nadomestiti z ustreznimi nadomestnimi antioksidanti, saj trenutno dovoljeni nadomestni antioksidanti, od katerih jih je več še vedno v postopku ponovne ocene v skladu z Uredbo (ES) št. 1831/2003, nimajo enakih lastnosti kot etoksikvin, zlasti v zvezi z učinkovitostjo in potrebno koncentracijo aktivne snovi, trajanjem delovanja, obnašanjem pri obdelavi, pa tudi v zvezi s proizvodnimi stroški.
Those feed additives consist in preparations of certain essential vitamins, carotenoids and colourants which are lipo-soluble and need to be protected during the manufacturing process, storage and transport of the preparations and of feed containing them, until the delivery to animals.
Zato je potreben določen čas, da nosilci dejavnosti lahko ocenijo in preskusijo funkcionalnost nadomestnih antioksidantov z novimi formulacijami in proizvodni proces prilagodijo glede na vključitev navedenih potencialnih nadomestnih snovi.
Due to the wide use of ethoxyquin in those feed additives preparations, an immediate withdrawal from the market of ethoxyquin would negatively impact animal health and welfare, as a result of a lack of essential micronutrients in the feed for several species of both food-producing and non-food producing animals.
Zato bi bilo treba določiti posebno omejeno prehodno obdobje za umik proizvodov iz uvodnih izjav 11 in 12 s trga, da bi se nosilci dejavnosti lahko prilagodili na nove razmere in tako ustrezno izpolnili obveznosti umika.
In addition, a shortage in the Union of the feed additives preparations concerned could lead to lower feed efficiency and lower livestock performance, but also to the inability to meet market specifications for certain animal products.
Zaradi posebnih metod proizvodnje in shranjevanja pripravkov krmnih dodatkov, navedenih v uvodni izjavi 12, bi bili nadomestni antioksidanti za te pripravke lahko na voljo prej kot za posamična krmila iz uvodne izjave 11, kar bi omogočilo določitev krajšega prehodnega obdobja.
It appears that a substitution of ethoxyquin by suitable alternative antioxidants could not be undertaken immediately, as the currently authorised alternative antioxidants — several of them being still under re-evaluation process in accordance with Regulation (EC) No 1831/2003 — do not possess the same characteristics as ethoxyquin, in particular as regards effectiveness and the concentration of active substance needed, duration of action, process behaviour but also in terms of production costs.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
Consequently, a certain time is needed in order to allow operators to evaluate and test the functionality of alternative antioxidants through new formulations and to adapt the production process to the inclusion of those potential alternative substances.
SPREJELA NASLEDNJO UREDBO:
A specific definite transition period should therefore be provided for the withdrawal from the market of the products referred to in recitals 11 and 12, in order to enable operators to adapt themselves to the new situation and thereby to comply properly with the withdrawal obligation.
Člen 1
Due to the specific method of production and storage of the feed additives preparations mentioned under recital 12, alternative antioxidant substances for those preparations may be made available in a shorter period than for the feed materials referred to in recital 11, allowing the provision of a shorter transitional period.
Začasni preklic dovoljenja
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Dovoljenje, določeno v Direktivi 70/524/EGS in podaljšano z Uredbo (ES) št 1831/2003, ki se nanaša na etoksikvin, ki je v register krmnih dodatkov iz člena 17 navedene uredbe vpisan pod oznako E 324, se začasno prekliče.
Article 1
Prehodni ukrepi
Suspension of the authorisation
Obstoječe zaloge etoksikvina in premiksov, ki ga vsebujejo, se lahko še naprej dajejo na trg do 28. septembra 2017 in se lahko uporabljajo do 28. decembra 2017 v skladu s pravili, veljavnimi pred 28. junijem 2017.
The authorisation provided by Directive 70/524/EEC and extended by Regulation (EC) No 1831/2003, concerning the additive ethoxyquin specified in entry E 324 of the Register of feed additives referred to in Article 17 of that Regulation (‘the additive ethoxyquin’), is suspended.
Posamična krmila in krmne mešanice, izdelane z etoksikvinom ali premiksi, ki ga vsebujejo, se lahko še naprej dajejo na trg do 28. decembra 2017 in se lahko uporabljajo do 28. marca 2018 v skladu s pravili, veljavnimi pred 28. junijem 2017.
Transitional measures
Posebni prehodni ukrepi za nekatera posamična krmila in povezane proizvode
Existing stocks of the additive ethoxyquin and of premixtures containing it may continue to be placed on the market until 28 September 2017 and may be used until 28 December 2017 in accordance with the rules applicable before 28 June 2017.
Z odstopanjem od člena 2: