natgillin/translations-raw huggingface dataset:
Commission Implementing Decision (EU) 2016/2278 of 15 December 2016 on the equivalence of the regulatory framework for central counterparties in the United Arab Emirates in accordance with Regulation (EU) No 648/2012 of the European Parliament and of the Council (OJ L 342, 16.12.2016, p. 68).
Provedbena odluka Komisije (EU) 2016/2278 оd 15. prosinca 2016. o istovrijednosti regulatornog okvira za središnje druge ugovorne strane u Ujedinjenim Arapskim Emiratima u skladu s Uredbom (EU) br. 648/2012 Europskog parlamenta i Vijeća (SL L 342, 16.12.2016., str. 68.).
Commission Implementing Decision (EU) 2016/2274 of 15 December 2016 on the equivalence of the regulatory framework for central counterparties in New Zealand in accordance with Regulation (EU) No 648/2012 of the European Parliament and of the Council (OJ L 342, 16.12.2016, p. 54).
Provedbena odluka Komisije (EU) 2016/2274 оd 15. prosinca 2016. o istovrijednosti regulatornog okvira za središnje druge ugovorne strane na Novom Zelandu u skladu s Uredbom (EU) br. 648/2012 Europskog parlamenta i Vijeća (SL L 342, 16.12.2016., str. 54.).
In spite of these developments, the remaining third-country CCPs are still awaiting recognition and the recognition process will not be completed by 15 June 2017.
Unatoč tome, preostale središnje druge ugovorne strane iz trećih zemalja i dalje čekaju priznavanje, a postupak priznavanja neće biti dovršen do 15. lipnja 2017.
Commission Delegated Regulation (EU) 2017/959
Delegirana uredba Komisije (EU) 2017/959
on the classification of horizontal settlement and short-term water absorption performance for in situ formed loose fill cellulose (LFCI) thermal insulation products under EN 15101-1 pursuant to Regulation (EU) No 305/2011 of the European Parliament and of the Council
o klasifikaciji svojstava horizontalnog slijeganja i kratkoročne apsorpcije vode za na mjestu oblikovane toplinsko-izolacijske proizvode od celuloznog punila (LFCI) iz norme EN 15101-1 na temelju Uredbe (EU) br. 305/2011 Europskog parlamenta i Vijeća
Where the Commission has not established classes of performance in relation to the essential characteristics of construction products, according to Article 27(2) of Regulation (EU) No 305/2011 they may be established by the European standardisation bodies, but only on the basis of a revised mandate.
Ako Komisija nije utvrdila razrede svojstava u odnosu na bitne značajke građevnih proizvoda, u skladu s člankom 27. stavkom 2. Uredbe (EU) br. 305/2011 mogu ih utvrditi europska tijela za normizaciju, ali samo na temelju revidiranog ovlaštenja.
The European product standard EN 15101-1 on in situ formed loose fill cellulose (LFCI) thermal insulation products contains classifications of performance concerning two of their essential characteristics, settlement for horizontal applications, lofts and floors, as well as short-term water absorption.
Europska norma za proizvod EN 15101-1 o na mjestu oblikovanim toplinsko-izolacijskim proizvodima od celuloznog punila (LFCI) sadržava klasifikacije svojstava koje se odnose na dvije njezine ključne značajke, slijeganje za vodoravne primjene, potkrovlja i etaže, kao i kratkoročnu apsorpciju vode.
These classifications represent a step forward for the consolidation of the internal market for the products in question.
Te klasifikacije predstavljaju korak naprijed u jačanju unutarnjeg tržišta za predmetne proizvode.
For those new classifications, a revised mandate has not been issued.
Za te nove klasifikacije nije izdano revidirano ovlaštenje.
New classification systems to be used for products covered by EN 15101-1 should therefore be established,
Stoga bi trebalo utvrditi novi klasifikacijski sustav koji treba upotrebljavati za proizvode obuhvaćene normom EN 15101-1,
The performance of in situ formed loose fill cellulose (LFCI) thermal insulation products, in relation to their essential characteristics, settlement for horizontal applications, lofts and floors, as well as short-term water absorption, shall be classified in accordance with the classification systems set out in the Annex.
Svojstva na mjestu oblikovanih toplinsko-izolacijskih proizvoda od celuloznog punila (LFCI) u odnosu na njihove bitne značajke slijeganja za vodoravne primjene, potkrovlja i etaže, kao i kratkoročne apsorpcije vode, razvrstavaju se u skladu s klasifikacijskim sustavima utvrđenima u Prilogu.
Classes for settlement for horizontal applications, lofts and floors
Razredi slijeganja za vodoravne primjene, potkrovlja i etaže
No measureable settlement (≤ 1 %)
Bez mjerljivog slijeganja (≤ 1 %)
Classes of short-term water absorption
Razredi kratkoročne apsorpcije vode
Commission Implementing Regulation (EU) 2017/960
Provedbena uredba Komisije (EU) 2017/960
A product in the form of a brownish, turbid extract of vanilla beans (which contains water and 35 % vol. alcohol as solvents), to which 5 % by weight of sugar has been added.
Proizvod u obliku smećkastog mutnog ekstrakta mahuna vanilije (koji kao otapala sadržava vodu i 35 % volumnog udjela alkohola) u koji je dodano 5 % masenog udjela šećera.
The product has an intense vanilla flavour and a distinctive taste of alcohol and sugar.
Proizvod ima intenzivnu aromu vanilije i prepoznatljiv okus alkohola i šećera.
It is put up for retail sale in 100 ml bottles and is used to improve the taste of dishes.
U maloprodaji se nalazi u bočicama od 100 ml i dodaje se jelima za poboljšavanje okusa.
Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and the wording of CN codes 2103, 210390 and 21039090.
Razvrstavanje se utvrđuje u skladu s općim pravilima 1 i 6 za tumačenje kombinirane nomenklature i nazivima oznaka KN 2103, 210390 i 21039090.
The product cannot be considered as a vegetable extract of heading 1302 as due to the addition of sugar it has the character of a food preparation (see also the Harmonized System Explanatory Notes (HSEN) to heading 1302, point (A), sixth paragraph).
Proizvod se ne može smatrati biljnim ekstraktom iz tarifnog broja 1302 jer su dodavanjem šećera dobivena obilježja prehrambenog proizvoda (vidjeti i Objašnjenja harmoniziranog sustava uz tarifni broj 1302, stavak 6. točka (A).
Preparations used to flavour certain dishes and made from various ingredients are to be classified under heading 2103 (see also the HSEN to heading 2103, point (A), first paragraph).
Pripravci za začinjanje jela dobiveni od različitih sastojaka razvrstavaju se u tarifni broj 2103 (vidjeti i Objašnjenja harmoniziranog sustava uz tarifni broj 2103, stavak 1. točka (A).
The product is therefore to be classified under CN code 21039090 as a mixed condiment or seasoning.
Proizvod se stoga razvrstava u oznaku KN 21039090 kao miješana začinska tvar ili začinsko sredstvo.
Commission Implementing Regulation (EU) 2017/961
Provedbena uredba Komisije (EU) 2017/961
concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No 887/2011 (holder of authorisation Evonik Nutrition & Care GmbH)
o odobrenju pripravka od Enterococcus faecium CECT 4515 kao dodatka hrani za odbijenu prasad i za novu uporabu u vodi za piće za odbijenu prasad i tovne piliće te o izmjeni Uredbe (EZ) br. 2036/2005 i Uredbe (EU) br. 887/2011 (nositelj odobrenja Evonik Nutrition & Care GmbH)
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 predviđena je ponovna procjena dodataka odobrenih u skladu s Direktivom Vijeća 70/524/EEZ [2].
The preparation of Enterococcus faecium CECT 4515 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for weaned piglets by Commission Regulation (EC) No 2036/2005 [3].
U skladu s Direktivom 70/524/EEZ pripravak od Enterococcus faecium CECT 4515 odobren je bez vremenskog ograničenja Uredbom Komisije (EZ) br. 2036/2005 [3] kao dodatak hrani za odbijenu prasad.
That preparation was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
Taj je pripravak nakon toga unesen u registar dodataka hrani za životinje kao postojeći proizvod u skladu s člankom 10. stavkom 1. točkom (b) Uredbe (EZ) br. 1831/2003.
That preparation has been authorised for chickens for fattening by Commission Implementing Regulation (EU) No 887/2011 [4].
Pripravak je Provedbenom uredbom Komisije (EU) br. 887/2011 [4] odobren za tovne piliće.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, applications were submitted for the re-evaluation of the preparation of Enterococcus faecium CECT 4515 as a feed additive in feed for weaned piglets and for a new use in water for drinking for weaned piglets and chickens for fattening.
U skladu s člankom 10. stavkom 2. Uredbe (EZ) br. 1831/2003 u vezi s njezinim člankom 7., podneseni su zahtjevi za ponovnu procjenu pripravka od Enterococcus faecium CECT 4515 kao dodatka hrani za odbijenu prasad i za novu uporabu u vodi za piće za odbijenu prasad i tovne piliće.
The applicant requested the additive to be classified in the additive category ‘zootechnical additives’.
Podnositelj zahtjeva zatražio je da se taj dodatak razvrsta u kategoriju dodataka „zootehnički dodaci”.
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 9 April 2014 [5], 29 April 2015 [6] and 8 September 2015 [7] that, under the proposed conditions of use, the preparation of Enterococcus faecium CECT 4515 does not have an adverse effect on animal health, human health or the environment.
Europska agencija za sigurnost hrane (dalje u tekstu: „Agencija”) u svojim je mišljenjima od 9. travnja 2014. [5], 29. travnja 2015. [6] i 8. rujna 2015. [7] zaključila da pripravak od Enterococcus faecium CECT 4515 u predloženim uvjetima uporabe nema negativan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš.
In its opinion of 29 April 2015, the Authority also concluded that the additive has the potential to improve the zootechnical performance of weaned piglets when used in feed.
Agencija je u svojem mišljenju od 29. travnja 2015. zaključila i da taj dodatak može poboljšati zootehnička obilježja odbijene prasadi kada se upotrebljava u hrani za životinje.
In its opinion of 8 September 2015, the Authority further concluded that the use of the preparation of Enterococcus faecium CECT 4515 in water for drinking for weaned piglets and chickens for fattening has the same efficacy as when it is used in feed.
Agencija je u svojem mišljenju od 8. rujna 2015. nadalje zaključila da je uporaba pripravka od Enterococcus faecium CECT 4515 u vodi za piće za odbijenu prasad i tovne piliće jednako učinkovita kao i kada se upotrebljava u hrani za životinje.
The assessment of the preparation of Enterococcus faecium CECT 4515 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Procjena pripravka od Enterococcus faecium CECT 4515 pokazala je da su ispunjeni uvjeti za odobrenje predviđeni člankom 5. Uredbe (EZ) br. 1831/2003.
Accordingly, the use of that preparation should be authorised as specified in the Annexes to this Regulation.
U skladu s tim trebalo bi odobriti uporabu tog pripravka kako je navedeno u prilozima ovoj Uredbi.
As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 2036/2005 should be amended accordingly.
S obzirom na izdavanje novog odobrenja u skladu s Uredbom (EZ) br. 1831/2003, trebalo bi na odgovarajući način izmijeniti Uredbu (EZ) br. 2036/2005.
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.
Nadalje, izmjenom te provedbene uredbe u postojeće bi odobrenje za pripravak od Enterococcus faecium CECT 4515 za tovne piliće u Provedbenoj uredbi (EU) br. 887/2011 trebalo dodati novu uporabu u vodi za piće.
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.
Pripravak naveden u Prilogu I., koji pripada kategoriji dodataka hrani za životinje „zootehnički dodaci” i funkcionalnoj skupini „stabilizatori crijevne flore”, odobrava se kao dodatak hrani za životinje u skladu s uvjetima utvrđenima u tom prilogu.
Amendment to Regulation (EC) No 2036/2005
Izmjena Uredbe (EZ) br. 2036/2005
In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
U Prilogu I. Uredbi (EZ) br. 2036/2005 briše se unos koji se odnosi na E 1713, Enterococcus faecium CECT 4515.
Amendment to Regulation (EU) No 887/2011
Izmjena Uredbe (EU) br. 887/2011
The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
Prilog Uredbi (EU) br. 887/2011 zamjenjuje se Prilogom II. ovoj 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.
Pripravak naveden u Prilogu i hrana za životinje koja taj pripravak sadržava, a koji su proizvedeni i označeni prije 28. prosinca 2017. u skladu s pravilima primjenjivima prije 28. lipnja 2017., mogu se nastaviti stavljati na tržište i upotrebljavati dok se ne potroše postojeće zalihe.
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 (EZ) br. 2036/2005 od 14. prosinca 2005. o trajnom odobrenju određenih dodataka hrani za životinje i privremenom odobrenju novog korištenja određenih već odobrenih dodataka hrani za životinje (SL 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).
Provedbena uredba Komisije (EU) br. 887/2011 od 5. rujna 2011. o odobrenju pripravka od Enterococcus faecium CECT 4515 kao dodatka hrani za tovne piliće (nositelj odobrenja Evonik Nutrition & Care GmbH) (SL L 229, 6.9.2011., str. 7.).
EFSA Journal 2014;12(5):3672.
EFSA Journal 2014.;12(5):3672.
EFSA Journal 2015;13(5):4111.
EFSA Journal 2015.;13(5):4111.
EFSA Journal 2015; 13(9):4232.
EFSA Journal 2015.; 13(9):4232.
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid form
Pripravak od Enterococcus faecium CECT 4515 koji sadržava najmanje 1 × 109 CFU/g dodatka u krutom obliku.
Viable cells of Enterococcus faecium CECT 4515
Žive stanice Enterococcus faecium CECT 4515
The additive may be used in water for drinking.
Dodatak se smije upotrebljavati u vodi za piće.
In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
U uputama za uporabu dodatka i premiksā navodi se stabilnost u vodi za piće.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
U uputama za uporabu dodatka i premiksā navode se uvjeti skladištenja i stabilnost pri zagrijavanju.
For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.
Za uporabu dodatka u vodi za piće mora se osigurati homogeno raspršenje dodatka.
For use in weaned piglets up to 35 kg of body weight.
Za odbijenu prasad do 35 kg tjelesne mase.
28 June 2027
28. lipnja 2027.
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive
Pripravak od Enterococcus faecium CECT 4515 koji sadržava najmanje 1 × 109 CFU/g dodatka.
Solid forms
Kruto stanje
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.
Dopuštena je uporaba u hrani za životinje koja sadržava jedan od sljedećih odobrenih kokcidiostatika: monenzin natrij, diklazuril, nikarbazin, dekokinat, robenidin hidroklorid, semduramicin natrij, narazin, salinomicin natrij, lazalocid A natrij, narazin/nikarbazin ili maduramicin amonij.
26 September 2021
26. rujna 2021.
Solid forms.
Kruto stanje.
Analytical method [2]Enumeration: spread plate method using bile esculin azide agar (EN 15788)
Analitička metoda [2]Određivanje brojnosti: metoda razmazivanja uporabom žučnog eskulina azidnog agara (EN 15788)
Commission Implementing Regulation (EU) 2017/962
Provedbena uredba Komisije (EU) 2017/962
suspending the authorisation of ethoxyquin as a feed additive for all animal species and categories
o suspenziji odobrenja za etoksikvin kao dodatak hrani za sve životinjske vrste i kategorije
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1], and in particular Article 13(2) thereof,
uzimajući u obzir Uredbu (EZ) br. 1831/2003 Europskog parlamenta i Vijeća od 22. rujna 2003. o dodacima za korištenje u hranidbi životinja [1], a posebno njezin članak 13. stavak 2.,
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.
Uredbom (EZ) br. 1831/2003 predviđeno je odobravanje dodataka hrani za životinje te osnove i postupci za izdavanje, odbijanje ili suspenziju takvog odobrenja.
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.
U skladu s Direktivom 70/524/EEZ dodatak etoksikvin odobren je bez vremenskog ograničenja kao dodatak hrani za sve životinjske vrste i kategorije.
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.
Stoga je taj dodatak unesen u registar dodataka hrani za životinje kao postojeći proizvod u skladu s člankom 10. stavkom 1. Uredbe (EZ) br. 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’.
U skladu s člankom 10. stavkom 2. Uredbe (EZ) br. 1831/2003 u vezi s njezinim člankom 7., dana 21. rujna 2010. podnesen je zahtjev za odobrenje etoksikvina kao dodatka hrani za sve životinjske vrste u kojem se traži da se taj dodatak razvrsta u kategoriju „tehnološki dodaci”.
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.
Europska agencija za sigurnost hrane („Agencija”) u svojem je mišljenju od 21. listopada 2015. [3] navela da na temelju ocjene pojedinosti i dokumenata koje je dostavio podnositelj nije moguće donijeti zaključak o sigurnosti dodatka etoksikvin za bilo koje ciljne životinje, za potrošače i za okoliš.
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 sveukupna je nedovoljnost dostavljenih podataka za procjenu izloženosti i sigurnosti etoksikvina za životinje, potrošače i okoliš.
In particular, no conclusion is possible on the absence of genotoxicity of one of the metabolites of the additive ethoxyquin, ethoxyquin quinone imine.
Zaključak nije moguće donijeti osobito o izostanku genotoksičnosti jednog od metabolita dodatka etoksikvin, tj. metabolita etoksikvin kvinon imin.
In addition, p-phenetidine, an impurity of the additive ethoxyquin, is recognised as a possible mutagen.
Osim toga, utvrđeno je da je p-fenetidin, koji je prisutan kao nečistoća u dodatku etoksikvin, mogući mutagen.
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 smatra da je dodatak etoksikvin snažan antioksidant u hrani za životinje, ali njegova učinkovitost na predloženoj razini uporabe, koja je smanjena u usporedbi s trenutačno odobrenom najvećom dopuštenom količinom u hrani za životinje, nije se mogla potvrditi na temelju dostavljenih podataka.
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.
Agencija je također potvrdila izvješće o metodi analize dodatka hrani za životinje koje je dostavio referentni laboratorij osnovan Uredbom (EZ) br. 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.
Stoga nije ustanovljeno da taj dodatak u predloženim uvjetima uporabe nema negativan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš.
The existing authorisation of the additive ethoxyquin therefore no longer meets the conditions set out by Article 5 of Regulation (EC) No 1831/2003.
Postojeće odobrenje dodatka etoksikvin stoga više ne ispunjava uvjete iz članka 5. Uredbe (EZ) br. 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.
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.
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.
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.
Those studies would consist essentially of an update of the additive's characterisation, in particular as regards relevant impurities and degradation products, of toxicological studies, in particular related to the genotoxicity of ethoxyquin quinone imine, of metabolism and residue studies in target animal species (including levels of residues in tissues and animal products), of target animals' safety studies and of an environmental risk assessment.
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.