natgillin/translations-raw huggingface dataset:
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.
Moguće je da iz dodatnih podataka o sigurnosti uporabe i učinkovitosti dodatka etoksikvin proizađu novi elementi koji bi omogućili ponovno razmatranje procjene provedene za taj dodatak.
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 tom pogledu podnositelj zahtjeva za odobrenje dodatka etoksikvin tvrdi da je moguće provesti nove studije kako bi se dokazala sigurnost i učinkovitost tog dodatka.
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.
Te će studije u suštini obuhvaćati ažuriranje karakteristika tog dodatka, osobito u pogledu relevantnih nečistoća i produkata razgradnje, toksikološke studije, osobito povezane sa genotoksičnošću tvari etoksikvin kinon imin, studije metabolizma i ostataka u ciljnim životinjskim vrstama (uključujući razine ostataka u tkivima i proizvodima životinjskog podrijetla), studije sigurnosti ciljnih životinja i procjenu rizika za okoliš.
The suspension measure should be reviewed after due assessment of those data by the Authority.
U skladu s člankom 13. stavkom 2.
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.
Uredbe (EZ) br. 1831/2003 odobrenje dodatka etoksikvin stoga bi trebalo suspendirati do dostavljanja i procjene dodatnih podataka.
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might cause a risk to human, animal health and the environment, the additive and feed containing it should be withdrawn from the market as soon as possible.
Mjeru suspenzije potrebno je preispitati nakon što Agencija provede odgovarajuću procjenu tih podataka.
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.
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.
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.
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.
Due to that high risk of oxidation, ethoxyquin is widely used to protect the feed materials concerned in an effective manner.
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.
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.
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.
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.
Zbog visokog rizika oksidacije, etoksikvin je u širokoj upotrebi kao sredstvo za učinkovitu zaštitu predmetnih krmiva.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
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.
HAS ADOPTED THIS REGULATION:
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.
Article 1
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Suspension of the authorisation
DONIJELA JE OVU UREDBU:
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.
Članak 1.
Article 2
Suspenzija odobrenja
Transitional measures
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.
Članak 2.
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.
Prijelazne mjere
Article 3
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.
Specific transitional measures for certain feed materials and related products
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.
By way of derogation from Article 2:
Članak 3.
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;
Posebne prijelazne mjere za određena krmiva i povezane proizvode
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;
Odstupajući od članka 2.:
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.
dodatak etoksikvin i premiksi koji ga sadržavaju, a namijenjeni su ugradnji u krmiva iz unosa 7.1.2. i poglavlja 10.
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.
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;
Article 4
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.;
Specific transitional measures for certain additives preparations and related products
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 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:
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.
preparations of vitamin A;
Članak 4.
preparations of vitamin D;
Posebne prijelazne mjere za određene pripravke koji se upotrebljavaju kao dodaci i povezane proizvode
preparations of vitamin E;
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 K;
pripravci vitamina A,
preparations of lutein;
pripravci vitamina D,
preparations of zeaxanthin;
pripravci vitamina E,
preparations of ethyl ester of beta-apo-8′-carotenoic acid;
pripravci vitamina K,
preparations of citranaxanthin;
pripravci luteina,
preparations of capsanthin;
pripravci zeaksantina,
preparations of astaxanthin;
pripravci etil ester beta-apo-8′-karotenske kiseline,
preparations of astaxanthin dimethyldisuccinate;
pripravci citranaksanatina,
preparations of canthaxanthin;
pripravci kapsanatina,
preparations of beta-carotene;
pripravci astaksantina,
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 astaksantin dimetil disuksinata,
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.
pripravci kantaksantina,
Article 5
pripravci betakarotena;
Review
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.;
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.
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.
Entry into force
Preispitivanje
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Članak 6.
Done at Brussels, 7 June 2017.
Stupanje na snagu
OJ L 268, 18.10.2003, p. 29.
Sastavljeno u Bruxellesu 7. lipnja 2017.
OJ L 270, 14.12.1970, p. 1.
Za Komisiju
EFSA Journal 2015; 13(11):4272.
Predsjednik
Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 29, 30.1.2013, p. 1).
SL L 268, 18.10.2003., str. 29.
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.
SL L 270, 14.12.1970., str. 1.
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.
EFSA Journal 2015.; 13(11):4272.
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].
That preparation 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.
Taj je pripravak nakon toga uvršten u registar dodataka hrani za životinje kao postojeći proizvod u skladu s člankom 10. stavkom 1.
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.
Uredbe (EZ) br. 1831/2003.
The applicant requested that additive to be classified in the additive category ‘zootechnical additives’.
U skladu s člankom 10. stavkom 2.