natgillin/translations-raw huggingface dataset:
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.
U skladu s člankom 13. stavkom 2. Uredbe (EZ) br. 1831/2003 odobrenje dodatka etoksikvin stoga bi trebalo suspendirati do dostavljanja i procjene dodatnih podataka.
The suspension measure should be reviewed after due assessment of those data by the Authority.
Mjeru suspenzije potrebno je preispitati nakon što Agencija provede odgovarajuću procjenu tih podataka.
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.
Preispitivanje mjere suspenzije trebalo bi se u svakom slučaju provesti ako tijekom procesa podnošenja i procjene dodatnih podataka Agencija donese nepovoljno mišljenje o sigurnosti ili učinkovitosti dodatka etoksikvin.
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might cause a risk to human, animal health and the environment, the additive and feed containing it should be withdrawn from the market as soon as possible.
Budući da bi dodatak etoksikvin mogao prouzročiti opasnost za zdravlje ljudi, zdravlje životinja i za okoliš, taj dodatak i hranu za životinje koja ga sadržava potrebno je povući s tržišta što je prije moguće.
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.
Međutim iz praktičnih razloga potrebno je omogućiti ograničeno prijelazno razdoblje za povlačenje predmetnih proizvoda s tržišta kako bi se gospodarskim subjektima omogućilo da propisno ispune obvezu povlačenja.
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.
Krmiva morskoga podrijetla koja sadržavaju visoke razine masnih kiselina vrlo su osjetljiva na oksidaciju i visoke temperature i potrebno ih je stabilizirati s pomoću antioksidanta, osobito u slučaju dugotrajnog prijevoza ili skladištenja.
Due to that high risk of oxidation, ethoxyquin is widely used to protect the feed materials concerned in an effective manner.
Zbog visokog rizika oksidacije, etoksikvin je u širokoj upotrebi kao sredstvo za učinkovitu zaštitu predmetnih krmiva.
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.
Ta krmiva, osobito riblje brašno i riblje ulje, imaju visoku nutritivnu vrijednost i sadržavaju znatnu koncentraciju lako probavljivih bjelančevina, koje su potrebne u prehrani životinja akvakulture i mladih životinja, ali se upotrebljavaju i za druge životinjske vrste, osobito za svinje i perad.
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.
Osim toga, ta krmiva imaju visok sadržaj višestruko nezasićenih masnih kiselina, koje se prenose u proizvode životinjskog podrijetla, i utvrđeno je da su korisne za zdravlje stoke i potrošača proizvoda životinjskog podrijetla.
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.
Zato bi trenutačno povlačenje etoksikvina s tržišta moglo imati negativne posljedice za zdravlje i dobrobit životinja i dovesti do nemogućnosti zadovoljavanja posebnih prehrambenih potreba životinja dok ne budu na raspolaganju adekvatne alternative.
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.
Etoksikvin je također u širokoj upotrebi kao sastojak određenih pripravaka koji se upotrebljavaju kao dodaci hrani za životinje, a sadržavaju aktivnu tvar koja je osobito osjetljiva na oksidaciju i toplinsku obradu te ju je potrebno stabilizirati s pomoću antioksidanta kako bi zadržala svoja svojstva.
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.
Ti dodaci hrani za životinje sastoje se od pripravaka određenih bitnih vitamina, karotenoida i bojila koji su topivi u mastima i potrebno ih je zaštititi tijekom postupka proizvodnje, skladištenja i prijevoza pripravaka i hrane za životinje koja ih sadržava, sve do davanja životinjama.
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.
Zbog široke upotrebe etoksikvina u tim pripravcima koji se upotrebljavaju kao dodaci hrani za životinje, trenutačno povlačenje etoksikvina s tržišta negativno bi utjecalo na zdravlje i dobrobit životinja jer bi za posljedicu imalo pomanjkanje bitnih mikronutrijenata u hrani za životinje za nekoliko životinjskih vrsta, od kojih neke služe, a neke ne služe za proizvodnju hrane.
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.
Osim toga, pomanjkanje predmetnih pripravaka koji se upotrebljavaju kao dodaci hrani za životinje moglo bi dovesti do smanjenja učinkovitosti hrane za životinje i niže proizvodnosti stoke, ali i do nemogućnosti zadovoljavanja tržišnih specifikacija za određene proizvode životinjskog podrijetla.
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.
Ne čini se da bi etoksikvin bilo moguće odmah nadomjestiti odgovarajućim alternativnim antioksidantima jer trenutačno odobreni alternativni antioksidanti (za nekoliko njih postupak ponovne procjene u skladu s Uredbom (EZ) br. 1831/2003 još je u tijeku) nemaju ista svojstva kao etoksikvin, osobito u pogledu učinkovitosti i koncentracije potrebne aktivne tvari, trajanja djelovanja, ponašanja tijekom procesa, a i u pogledu troškova proizvodnje.
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.
Stoga je potrebno određeno vrijeme kako bi se gospodarskim subjektima omogućilo da procijene i testiraju funkcionalnost alternativnih antioksidanata u novim formulacijama i da svoj proizvodni proces prilagode s obzirom na uvođenje tih potencijalno alternativnih tvari.
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.
Stoga je za povlačenje s tržišta proizvoda navedenih u uvodnim izjavama 11. i 12. potrebno omogućiti ograničeno prijelazno razdoblje kako bi se gospodarskim subjektima omogućilo da se prilagode novoj situaciji i propisno ispune obvezu povlačenja.
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.
Zbog specifičnog načina proizvodnje i skladištenja pripravaka koji se upotrebljavaju kao dodaci hrani za životinje navedenih u uvodnoj izjavi 12., alternativne antioksidativne tvari za te pripravke mogu se staviti na raspolaganje u kraćem roku nego krmiva navedena u uvodnoj izjavi 11., pa je za njih moguće odrediti kraće prijelazno razdoblje.
Suspension of the authorisation
Suspenzija odobrenja
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.
Odobrenje predviđeno Direktivom 70/524/EEZ i produljeno Uredbom (EZ) br. 1831/2003 za dodatak etoksikvin iz unosa E 324. registra dodataka hrani za životinje na koji se upućuje u članku 17. te Uredbe („dodatak etoksikvin”) suspendira se.
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.
Postojeće zalihe dodatka etoksikvin i premiksā koji ga sadržavaju mogu se nastaviti stavljati na tržište do 28. rujna 2017. i mogu se upotrebljavati do 28. prosinca 2017. u skladu s pravilima primjenjivima prije 28. lipnja 2017.
Feed materials and compound feed produced with the additive ethoxyquin or with premixtures containing it may continue to be placed on the market until 28 December 2017 and may be used until 28 March 2018 in accordance with the rules applicable before 28 June 2017.
Krmiva i krmne smjese proizvedeni s dodatkom etoksikvin ili premiksima koji ga sadržavaju mogu se nastaviti stavljati na tržište do 28. prosinca 2017. i mogu se upotrebljavati do 28. ožujka 2018. u skladu s pravilima primjenjivima prije 28. lipnja 2017.
Specific transitional measures for certain feed materials and related products
Posebne prijelazne mjere za određena krmiva i povezane proizvode
By way of derogation from Article 2:
Odstupajući od članka 2.:
the additive ethoxyquin and premixtures containing it, intended to be incorporated in the feed materials listed under entry 7.1.2 and under Chapter 10 of the Catalogue of feed materials established by Commission Regulation (EU) No 68/2013 [4], may continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 30 September 2019, provided that the label of the additive ethoxyquin or of premixtures containing it mentions the intended incorporation in those feed materials;
dodatak etoksikvin i premiksi koji ga sadržavaju, a namijenjeni su ugradnji u krmiva iz unosa 7.1.2. i poglavlja 10. Kataloga krmiva uspostavljenog Uredbom Komisije (EU) br. 68/2013 [4], mogu se nastaviti stavljati na tržište do 30. rujna 2019. u skladu s pravilima primjenjivima prije 28. lipnja 2017., uz uvjet da je na oznaci dodatka etoksikvin ili premiksā koji ga sadržavaju navedeno da su namijenjeni za ugradnju u ta krmiva;
feed materials referred to in point (a) produced with the additive ethoxyquin or with premixtures containing it may continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 31 December 2019;
krmiva navedna u točki (a) proizvedena s dodatkom etoksikvinom ili s premiksima koji ga sadržavaju mogu se nastaviti stavljati na tržište do 31. prosinca 2019. u skladu s pravilima primjenjivima prije 28. lipnja 2017.;
compound feed produced with the feed materials referred to in point (b) may continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 31 March 2020.
krmne smjese proizvedene s krmivima navedenima u točki (b) mogu se nastaviti stavljati na tržište do 31. ožujka 2020. u skladu s pravilima primjenjivima prije 28. lipnja 2017.;
The products referred to in points (a), (b) and (c) of paragraph 1 may be used in accordance with the rules applicable before 28 June 2017 until 3 months after the dates specified respectively in those points.
Proizvodi navedeni u stavku 1. točkama (a), (b) i (c) mogu se upotrebljavati do 3 mjeseca nakon datuma navedenog u točki (a) odnosno točki (b) odnosno točki (c) u skladu s pravilima primjenjivima prije 28. lipnja 2017.
Specific transitional measures for certain additives preparations and related products
Posebne prijelazne mjere za određene pripravke koji se upotrebljavaju kao dodaci i povezane proizvode
the additive ethoxyquin intended to be incorporated in the following additives preparations which have been authorised in accordance with Regulation (EC) No 1831/2003, may continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 31 March 2018, provided that the label of the additive ethoxyquin mentions the intended incorporation in those additives preparations:
dodatak etoksikvin namijenjen za ugradnju u sljedeće pripravke koji se upotrebljavaju kao dodaci odobrene u skladu s Uredbom (EZ) br. 1831/2003 mogu se nastaviti stavljati na tržište do 31. ožujka 2018. u skladu s pravilima primjenjivima prije 28. lipnja 2017., uz uvjet da je na oznaci dodatka etoksikvin navedeno da je namijenjen za ugradnju u te pripravke koji se upotrebljavaju kao dodaci:
preparations of vitamin A;
pripravci vitamina A,
preparations of vitamin D;
pripravci vitamina D,
preparations of vitamin E;
pripravci vitamina E,
preparations of vitamin K;
pripravci vitamina K,
preparations of lutein;
pripravci luteina,
preparations of zeaxanthin;
pripravci zeaksantina,
preparations of ethyl ester of beta-apo-8′-carotenoic acid;
pripravci etil ester beta-apo-8′-karotenske kiseline,
preparations of citranaxanthin;
pripravci citranaksanatina,
preparations of capsanthin;
pripravci kapsanatina,
preparations of astaxanthin;
pripravci astaksantina,
preparations of astaxanthin dimethyldisuccinate;
pripravci astaksantin dimetil disuksinata,
preparations of canthaxanthin;
pripravci kantaksantina,
preparations of beta-carotene;
pripravci betakarotena;
the additives preparations referred to in point (a) which contain the additive ethoxyquin and premixtures containing those additives preparations may continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 30 June 2018;
pripravci koji se upotrebljavaju kao dodaci navedeni u točki (a) koji sadržavaju dodatak etoksikvin i premiksi koji sadržavaju te pripravke mogu se nastaviti stavljati na tržište do 30. lipnja 2018. u skladu s pravilima primjenjivima prije 28. lipnja 2017.;
feed materials and compound feed containing the products referred to in point (b) may continue to be placed on the market in accordance with the rules applicable before 28 June 2017 until 30 September 2018.
krmiva i krmne smjese koji sadržavaju proizvode navedene u točki (b) mogu se nastaviti stavljati na tržište do 30. rujna 2018. u skladu s pravilima primjenjivima prije 28. lipnja 2017.
This Regulation shall be reviewed by 31 December 2020 at the latest and in any event after the adoption by the Authority of a non-favourable opinion on the safety or efficacy of the additive ethoxyquin.
Ova Uredba preispitat će se najkasnije do 31. prosinca 2020. i u svakom slučaju ako Agencija donese nepovoljno mišljenje o sigurnosti ili učinkovitosti dodatka etoksikvin.
EFSA Journal 2015; 13(11):4272.
EFSA Journal 2015.; 13(11):4272.
To this end, the applicant committed itself to produce supplementary data according to a time schedule listing in order of priority the studies to be carried out successively and planning that the outcome of the last of them would be available by July 2018.
U tu svrhu podnositelj se obavezao dostavljati dodatne podatke prema određenom vremenskom rasporedu u skladu s redoslijedom prioriteta studija koje će se sukcesivno provesti, a planira da će rezultati posljednje od tih studija biti dostupni u srpnju 2018.
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.
U postupku planiranog generiranja podataka određivanje prioriteta temelji se na razini važnosti pojedinih pitanja utvrđenih u mišljenju Agencije.
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.
Usto, budući da je prisutnost nečistoće p-fenetidin u dodatku etoksikvin rezultat postupka proizvodnje tog dodatka, podnositelj se obavezao poduzeti korake kako bi se do lipnja 2017. postupno smanjio sadržaj te nečistoće u dodatku do razine od 2,5 ppm p-fenetidina u etoksikvinu.
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.
U tu svrhu, podnositelj zahtjeva trebao bi dostaviti prikladnu metodu analize za otkrivanje p-fenetidina u dodatku etoksikvin i u hrani koja sadržava taj dodatak, a Agencija bi tu metodu trebala potvrditi na temelju izvješća referentnog laboratorija osnovanog Uredbom (EZ) br. 1831/2003.
Commission Implementing Regulation (EU) 2017/963
Provedbena uredba komisije (EU) 2017/963
concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for all avian species and weaned piglets and amending Regulations (EC) No 358/2005 and (EU) No 1270/2009 (holder of the authorisation Kemin Europa NV)
o odobrenju pripravka endo-1,3(4)-beta-glukanaze proizvedenoga od Aspergillus aculeatinus (prethodno klasificiran kao Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glukanaze proizvedenoga od Trichoderma reesei (prethodno klasificirana kao Trichoderma longibrachiatum) (CBS 592.94), alfa-amilaze proizvedenoga od Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-ksilanaze proizvedenoga od Trichoderma viride (NIBH FERM BP4842) i bacilolizina proizvedenoga od Bacillus amyloliquefaciens (DSM 9554) kao dodatka hrani za sve ptičje vrste i odbijenu prasad te o izmjeni uredbi (EZ) br. 358/2005 i (EU) br. 1270/2009 (vlasnik odobrenja Kemin Europa NV)
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 Articles 9(2) thereof,
uzimajući u obzir Uredbu (EZ) br. 1831/2003 Europskog parlamenta i Vijeća od 22. rujna 2003. o dodacima hrani za životinje [1], a posebno njezin članak 9. stavak 2.,
Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC [2].
Člankom 10. te uredbe propisuje se ponovna ocjena dodataka odobrenih u skladu s Direktivom Vijeća 70/524/EEZ [2].
The preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 358/2005 [3], for turkeys for fattening and weaned piglets by Commission Regulation (EU) No 1270/2009 [4].
U skladu s Direktivom 70/524/EEZ pripravak endo-1,3(4)-beta-glukanaze proizveden od Aspergillus aculeatinus (prethodno klasificiran kao Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glukanaze proizveden od Trichoderma reesei (prethodno klasificirana kao Trichoderma longibrachiatum) (CBS 592.94), alfa-amilaze proizveden od Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-ksilanaze proizveden od Trichoderma viride (NIBH FERM BP4842) i bacilolizina proizveden od Bacillus amyloliquefaciens odobren je bez vremenskog ograničenja kao dodatak hrani za piliće za tov Uredbom Komisije (EZ) br. 358/2005 [3], za purane za tov i odbijenu prasad Uredbom Komisije (EU) br. 1270/2009 [4].
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for chickens for fattening, turkeys for fattening and for weaned piglets and, in accordance with Article 7 of that Regulation, for a new authorisation as a feed additive for all avian species.
U skladu s člankom 10. stavkom 2. Uredbe (EZ) br. 1831/2003 u vezi s njezinim člankom 7., podnesen je zahtjev za ponovnu ocjenu pripravka endo-1,3(4)-beta-glukanaze proizvedenoga od Aspergillus aculeatinus (prethodno klasificiran kao Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glukanaze proizvedenoga od Trichoderma reesei (prethodno klasificirana kao Trichoderma longibrachiatum) (CBS 592.94), alfa-amilaze proizvedenoga od Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-ksilanaze proizvedenoga od Trichoderma viride (NIBH FERM BP4842) i bacilolizina proizvedenoga od Bacillus amyloliquefaciens (DSM 9554) kao dodatka hrani za piliće za tov, purane za tov i za odbijenu prasad te, u skladu s člankom 7. te uredbe, za novo odobravanje kao dodatka hrani za sve ptičje vrste.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Uz navedeni zahtjev priložene su pojedinosti i dokumenti propisani člankom 7. stavkom 3. Uredbe (EZ) br. 1831/2003.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 September 2015 [5] that, under the proposed conditions of use, it does not have an adverse effect on animal health, human health or the environment.
Europska agencija za sigurnost hrane (dalje u tekstu „Agencija”) u svojem je mišljenju od 9. rujna 2015. [5] zaključila da pripravak u predloženim uvjetima upotrebe nema nepovoljan učinak na zdravlje životinja, zdravlje ljudi ni na okoliš.
The Authority also concluded that the use of that preparation has the potential to be efficacious in chickens for fattening, turkeys for fattening and in laying hens [6].
Agencija je zaključila i da bi upotreba tog pripravka mogla biti učinkovita za piliće za tov, purane za tov i kokoši nesilice [6].