natgillin/translations-raw huggingface dataset:
Done at Brussels, 11 July 2018.
Uredbe (EZ) br. 854/2004 mijenja se kako bi se uklonili svi unosi za brazilske objekte iz kojih je dopušten uvoz u Uniju proizvoda ribarstva namijenjenih prehrani ljudi.
Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27).
Sastavljeno u Bruxellesu 11. srpnja 2018.
In reply to the recommendations made in the preliminary inspection report, the Brazilian authorities informed the Commission, in an official letter dated 22 December 2017, that they have suspended the issuance of health certificates for all fishery products intended for export to the Union as of 3 January 2018.
Za Komisiju
Commission Implementing Regulation (EU) 2018/982
Provedbena uredba Komisije (EU) 2018/982
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying.
U skladu s člankom 7.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Uredbe (EZ) br. 1831/2003 podnesen je zahtjev za odobrenje pripravka benzojeve kiseline, kalcijeva formata i fumarne kiseline kao dodatka hrani za piliće za tov, piliće uzgajane za nesenje te manje značajne ptičje vrste za tov i za nesenje.
That application concerns the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.
Uz navedeni zahtjev priloženi su podaci i dokumenti propisani člankom 7. stavkom 3.
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 December 2014 and 28 September 2017 that, under the proposed conditions of use, the preparation of benzoic acid, calcium formate and fumaric acid does not have an adverse effect on animal health, human health or the environment.
Uredbe (EZ) br. 1831/2003.
The Authority also concluded that it has the potential to improve the performance of chickens for fattening and this conclusion can be extended to chickens reared for laying.
Taj zahtjev odnosi se na odobrenje pripravka benzojeve kiseline, kalcijeva formata i fumarne kiseline kao dodatka hrani za piliće za tov, piliće uzgajane za nesenje i manje značajne ptičje vrste za tov i za nesenje te njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
However, since no conclusions can be drawn on the margin of safety of the additive for major target species, the conclusions on safety cannot be extrapolated to minor avian species for fattening and to minor avian species reared for laying.
Europska agencija za sigurnost hrane („Agencija”) u svojim je mišljenjima od 2. prosinca 2014. i 28. rujna 2017. zaključila da pripravak benzojeve kiseline, kalcijeva formata i fumarne kiseline u predloženim uvjetima uporabe nema štetan učinak na zdravlje životinja, zdravlje ljudi ili okoliš.
The Authority does not consider that there is a need for specific requirements of post-market monitoring.
Također je zaključila da se njime mogu poboljšati obilježja pilića za tov te da se taj zaključak može primijeniti i na piliće uzgajane za nesenje.
It 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.
Međutim, budući da se ne mogu izvući nikakvi zaključci o granici sigurne uporabe dodatka za glavne ciljane vrste, zaključci o sigurnosti ne mogu se primijeniti na manje zastupljene ptičje vrste za tov i manje zastupljene ptičje vrste za nesenje.
The assessment of the preparation of benzoic acid, calcium formate and fumaric acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Agencija smatra da ne postoji potreba za posebnim zahtjevima za praćenje nakon stavljanja na tržište.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Procjena pripravka benzojeve kiseline, kalcijeva formata i fumarne kiseline pokazala je da su ispunjeni uvjeti za odobrenje predviđeni člankom 5.
HAS ADOPTED THIS REGULATION:
Uredbe (EZ) br. 1831/2003.
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Pripravak naveden u Prilogu, koji pripada kategoriji dodataka „zootehnički dodaci” i funkcionalnoj skupini „ostali zootehnički dodaci”, odobrava se kao dodatak hrani za životinje podložno uvjetima utvrđenima u tom prilogu.
Done at Brussels, 11 July 2018.
Članak 2.
OJ L 268, 18.10.2003, p. 29.
Sastavljeno u Bruxellesu 11. srpnja 2018.
EFSA Journal 2015;13(5):3794.
Za Komisiju
EFSA Journal 2017;15(10):5025.
Predsjednik
ANNEX
SL L 268, 18.10.2003., str. 29.
Identification number of the additive
EFSA Journal 2015.; 13(5):3794.
Name of the holder of authorisation
EFSA Journal 2017.; 15(10):5025.
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
Najveća dopuštena količina
Functional group: other zootechnical additives (improving zootechnical performance)
Datum isteka valjanosti odobrenja
Preparation of benzoic acid, calcium formate and fumaric acid
mg dodatka/kg potpune krmne smjese s udjelom vlage od 12 %
Additive composition
Kategorija zootehničkih dodataka.
Preparation of benzoic acid, calcium formate and fumaric acid having a minimum content of:
Funkcionalna skupina: ostali zootehnički dodaci (poboljšanje zootehničkih obilježja)
Benzoic acid: 42,5-50 %
Pripravak benzojeve kiseline, kalcijeva formata i fumarne kiseline
Calcium formate: 2,5-3,5 %
Sastav dodatka
Fumaric acid: 0,8-1,2 %
Pripravak benzojeve kiseline, kalcijeva formata i fumarne kiseline s najmanjom dopuštenom količinom:
Granulated form
benzojeve kiseline: 42,5 %–50 %
Characterisation of the active substance
kalcijeva formata: 2,5 %–3,5 %
benzoic acid CAS number: 65-85-0 (≥ 99,0 % purity); C7H6O2
fumarne kiseline: 0,8 %–1,2 %
calcium formate: CAS number 544-17-2; C2H2O4Ca;
u obliku granula
fumaric acid (≥ 99,5 % purity): CAS number 110-17-8; C4H4O4.
Karakteristike aktivne tvari
Analytical method
benzojeva kiselina - CAS broj: 65-85-0 (faktor čistoće ≥ 99,0 %); C7H6O2
For the determination of benzoic acid, calcium formate and fumaric acid in the feed additive:
kalcijev format: CAS broj 544-17-2; C2H2O4Ca;
high performance liquid chromatography with UV detection (HPLC-UV)
fumarna kiselina (faktor čistoće ≥ 99,5 %): CAS broj 110-17-8;C4H4O4.
For the determination of total calcium in the feed additive:
Analitička metoda
atomic absorption spectrometry (AAS) – EN ISO 6869; or
Za određivanje benzojeve kiseline, kalcijeva formata i fumarne kiseline u dodatku hrani za životinje:
inductively coupled plasma atomic emission spectrometry (ICP-AES) – EN 15510
tekućinska kromatografija visoke djelotvornosti s UV detekcijom (HPLC-UV)
For the determination of benzoic acid in premixtures and feedingstuffs:
Za određivanje ukupnog sadržaja kalcija u dodatku hrani za životinje:
For the determination of calcium formate and fumaric acid in premixtures:
atomska apsorpcijska spektrometrija (AAS) – EN ISO 6869; ili
ion-exclusion high performance liquid chromatography with UV or refractive index detection (HPLC-UV/RI)
atomska emisijska spektrometrija s induktivno spregnutom plazmom (ICP-AES) – EN 15510
Chickens for fattening
Za određivanje benzojeve kiseline u premiksima i hrani za životinje:
Chickens reared for laying
Za određivanje kalcijeva formata i fumarne kiseline u premiksima:
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
tekućinska kromatografija visoke djelotvornosti ionskim isključenjem s UV detekcijom ili s detekcijom indeksa refrakcije (HPLC-UV/RI)
The additive shall not be used with other sources of benzoic acid or benzoates, calcium formate or formate and fumaric acid.
Pilići za tov
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use.
Pilići uzgajani za nesenje
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.
U uputama za uporabu dodatka hrani za životinje i premiksâ potrebno je navesti uvjete skladištenja i stabilnost pri toplinskoj obradi.
1 August 2028
Dodatak se ne smije upotrebljavati s drugim izvorima benzojeve kiseline ili benzoata, kalcijeva formata ili formata i fumarne kiseline.
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Za korisnike dodatka i premiksâ subjekti koji posluju s hranom za životinje dužni su utvrditi operativne postupke i organizacijske mjere za uklanjanje mogućih opasnosti u pogledu njihove uporabe.
Commission Implementing Regulation (EU) 2018/983
Provedbena uredba Komisije (EU) 2018/983
concerning the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.)
o odobrenju benzojeve kiseline kao dodatka hrani za manje značajne vrste svinja za tov i za rasplod (nositelj odobrenja DSM Nutritional Products Sp. z o. o.)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction.
U skladu s člankom 7.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Uredbe (EZ) br. 1831/2003 podnesen je zahtjev za odobrenje benzojeve kiseline kao dodatka hrani za manje značajne vrste svinja za tov i za rasplod.
That application concerns the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction, to be classified in the additive category ‘zootechnical additives’.
Uz navedeni zahtjev priloženi su podaci i dokumenti propisani člankom 7. stavkom 3.
That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006, in pigs for fattening by Commission Regulation (EC) No 1138/2007 and in sows by Commission Implementing Regulation (EU) 2016/900.
Uredbe (EZ) br. 1831/2003.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 that, under the proposed conditions of use, the benzoic acid does not have an adverse effect on human health or the environment, and that it has a potential to decrease urinary pH in minor porcine species.
Zahtjev se odnosi na odobrenje benzojeve kiseline kao dodatka hrani za manje značajne vrste svinja za tov i za rasplod te njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
However, due to the lack of margin of safety in weaned major piglets, the Authority could not extrapolate the conclusion on the safety to weaned minor porcine species.
Taj je dodatak već odobren kao dodatak hrani za životinje za odbijenu prasad Uredbom Komisije (EZ) br. 1730/2006, za svinje za tov Uredbom Komisije (EZ) br. 1138/2007 te za krmače Provedbenom uredbom Komisije (EU) 2016/900.
Therefore it was established the additive is safe for minor porcine species for fattening and for reproduction.
Europska agencija za sigurnost hrane („Agencija”) u svojem je mišljenju od 28. rujna 2017. zaključila da benzojeva kiselina u predloženim uvjetima uporabe nema negativan učinak na zdravlje životinja ili na okoliš te da može sniziti pH urina kod manje značajnih vrsta svinja.
The Authority does not consider that there is a need for specific requirements of post-market monitoring.
Međutim zbog nedostatka granice sigurne uporabe kod značajnih vrsta odbijene prasadi, Agencija nije mogla zaključak o sigurnosti primijeniti na odbijene manje značajne vrste svinja.
It 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.
Stoga je utvrđeno da je dodatak siguran za manje značajne vrste svinja za tov i za rasplod.
The assessment of the benzoic acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Agencija smatra da ne postoji potreba za posebnim zahtjevima za praćenje nakon stavljanja na tržište.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Procjena benzojeve kiseline pokazala je da su ispunjeni uvjeti za odobrenje predviđeni člankom 5.
The additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Dodatak hrani za životinje naveden u Prilogu, koji pripada kategoriji dodataka „zootehnički dodaci” i funkcionalnoj skupini „ostali zootehnički dodaci”, odobrava se kao dodatak hrani za životinje podložno uvjetima utvrđenima u tom prilogu.
Commission Regulation (EC) No 1730/2006 of 23 November 2006 concerning the authorisation of benzoic acid (VevoVitall) as a feed additive (OJ L 325, 24.11.2006, p. 9).
Za Komisiju
Commission Regulation (EC) No 1138/2007 of 1 October 2007 concerning the authorisation of a new use of benzoic acid (VevoVitall) as a feed additive (OJ L 256, 2.10.2007, p. 8).
Predsjednik
Commission Implementing Regulation (EU) 2016/900 of 8 June 2016 concerning the authorisation of benzoic acid as a feed additive for sows (holder of authorisation DSM Nutritional Products Ltd) (OJ L 152, 9.6.2016, p. 18).
SL L 268, 18.10.2003., str. 29.
EFSA Journal 2017;15(10):5026.
Uredba Komisije (EZ) br. 1730/2006 od 23. studenoga 2006. o odobrenju benzojeve kiseline (VevoVitall) kao dodatka hrani za životinje (SL L 325, 24.11.2006., str. 9.).
ANNEX
Uredba Komisije (EZ) br. 1138/2007 od 1. listopada 2007. o odobrenju novog korištenja benzoične kiseline (VevoVitall) kao dodatka hrani za životinje (SL L 256, 2.10.2007., str. 8.).
Identification number of the additive
Provedbena uredba Komisije (EU) 2016/900 od 8. lipnja 2016. o odobrenju benzojeve kiseline kao dodatka hrani za krmače (nositelj odobrenja DSM Nutritional products Ltd) (SL L 152, 9.6.2016., str. 18.).
Name of the holder of authorisation
EFSA Journal 2017.; 15(10):5026.
Species or category of animal
Naziv nositelja odobrenja
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Najveća dopuštena količina
Functional group: other zootechnical additives (urinary pH decrease).
Datum isteka valjanosti odobrenja
Benzoic acid
mg aktivne tvari po kg potpune krmne smjese s udjelom vlage od 12 %
Additive composition:
Kategorija zootehničkih dodataka.
Benzoic acid (≥ 99,9 %)
Funkcionalna skupina: ostali zootehnički dodaci (sniženje pH urina).
Characterisation of the active substance:
Benzojeva kiselina
Benzenecarboxylic acid, phenylcarboxylic acid,
Sastav dodatka:
CAS number 65-85-0
Benzojeva kiselina (≥ 99,9 %)
Maximum level of the impurities:
Karakteristike aktivne tvari:
Phthalic acid: ≤ 100 mg/kg
Benzenkarboksilna kiselina, fenilkarboksilna kiselina,
Biphenyl: ≤ 100 mg/kg
CAS broj 65-85-0
Analytical method
Najviša razina nečistoće:
For the quantification of benzoic acid in the feed additive:
Ftalna kiselina: ≤ 100 mg/kg
titration with sodium hydroxide (European Pharmacopoeia monograph 0066)
Bifenil: ≤ 100 mg/kg
For the quantification of the benzoic acid in the premixtures and feedingstuffs:
Analitička metoda
reversed phase liquid chromatography with UV detection (RP-HPLC/UV) — method based on ISO9231:2008
Za kvantifikaciju benzojeve kiseline u dodatku hrani za životinje:
Minor porcine species for fattening and for reproduction
titracija natrijevim hidroksidom (monografija Europske farmakopeje 0066)
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated..
Za kvantifikaciju benzojeve kiseline u premiksima i hrani za životinje:
The additive shall not be used with other sources of benzoic acid or benzoates.
tekućinska kromatografija s reverznom fazom i UV detekcijom (RP-HPLC/UV) – metoda temeljena na ISO9231:2008
The directions of use shall be indicated the following in complementary feed: ‘Complementary feedingstuffs containing benzoic acid shall not be fed to minor porcine species for fattening and for reproduction as such'.
Manje značajne vrste svinja za tov i za rasplod
Complementary feedingstuffs for sows shall be thoroughly mixed with other feed materials of the daily ration’.
U uputama za uporabu dodatka hrani za životinje i premiksâ potrebno je navesti uvjete skladištenja i stabilnost pri toplinskoj obradi.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use.
Dodatak se ne smije upotrebljavati s drugim izvorima benzojeve kiseline ili benzoata.
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 eyes and skin protection.
U uputama za uporabu dopunskih krmnih smjesa potrebno je navesti sljedeće: „Manje značajne vrste svinja za tov i za rasplod ne smiju se hraniti dopunskim krmnim smjesama koje sadržavaju benzojevu kiselinu.
1 August 2028
Dopunske krmne smjese za krmače potrebno je temeljito pomiješati s drugim krmivima u okviru dnevnog obroka”.
of 12 February 2018
оd 12. veljače 2018.
supplementing Regulation (EU) No 167/2013 of the European Parliament and of the Council as regards environmental and propulsion unit performance requirements for agricultural and forestry vehicles and their engines and repealing Commission Delegated Regulation (EU) 2015/96
o dopuni Uredbe (EU) br. 167/2013 Europskog parlamenta i Vijeća s obzirom na zahtjeve u pogledu učinka na okoliš i učinkovitosti pogonskih jedinica vozila za poljoprivredu i šumarstvo i njihovih motora te o stavljanju izvan snage Delegirane uredbe Komisije (EU) 2015/96
Having regard to Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles, and in particular Articles 19(6) and 20(8), 28(6) and 53(12), thereof,
uzimajući u obzir Uredbu (EU) br. 167/2013 Europskog parlamenta i Vijeća od 5. veljače 2013. o homologaciji i nadzoru tržišta traktora za poljoprivredu i šumarstvo, a posebno njezin članak 19. stavak 6., članak 20. stavak 8., članak 28. stavak 6. i članak 53. stavak 12.,
Given the application of the provisions of Regulation (EU) 2016/1628 of the European Parliament and of the Council — on engine categories, exhaust emission limits, test cycles, emission durability periods, exhaust emission requirements, the monitoring of emissions of in-service engines and the conduct of measurements and tests, as well as the transitional provisions and provisions allowing the early EU type-approval and the placing on the market of Stage V engines — to the environmental performance of agricultural and forestry vehicles, the provisions of this Regulation covering the remaining aspects of such approval should be closely modelled on those contained in Regulation (EU) 2016/1628.
S obzirom na to da se odredbe Uredbe (EU) 2016/1628 Europskog parlamenta i Vijeća primjenjuju na kategorije motora, granične vrijednosti emisija ispušnih plinova, ispitne cikluse, razdoblja trajnosti emisija, zahtjeve u vezi s emisijama ispušnih plinova, praćenje emisija motora u uporabi i provedbu mjerenja i ispitivanja, kao i s obzirom na to da se prijelazne odredbe i odredbe kojima se omogućuje rana EU homologacija tipa i stavljanje na tržište motora stupnja V. primjenjuju na učinak na okoliš vozila za poljoprivredu i šumarstvo, odredbe ove Uredbe koje obuhvaćaju preostale aspekte takve homologacije trebale bi biti oblikovane slično odredbama sadržanima u Uredbi (EU) 2016/1628.
For the purposes of the engine pollutant emission stage for agricultural and forestry vehicle engines, referred to as ‘Stage V’, that will succeed the one laid down in Commission Delegated Regulation (EU) 2015/96, ambitious gaseous and particulate matter pollutant emission limits should be set while aligning with international standards in order to reduce emissions of particulate matter and ozone precursors such as nitrogen oxides and hydrocarbons.
Za potrebe stupnja emisija onečišćujućih tvari iz motora vozila za poljoprivredu i šumarstvo („stupanj V.”), koji će zamijeniti onaj utvrđen Delegiranom uredbom Komisije (EU) 2015/96, trebalo bi utvrditi ambiciozne granične vrijednosti plinovitih i krutih onečišćujućih tvari te ih istodobno uskladiti s međunarodnim normama kako bi se smanjile emisije krutih tvari i prekursora ozona, poput dušikovih oksida i ugljikovodika.
Technical progress and high-level environmental protection require prescribing technical requirements for the introduction of Stage V in relation to agricultural and forestry vehicles, replacing the previous engine pollutant emission stages laid down in Delegated Regulation (EU) 2015/96.
Kako bi se popratio tehnički napredak i u visokoj mjeri zaštitilo okoliš, potrebno je propisati tehničke zahtjeve za uvođenje stupnja V. s obzirom na vozila za poljoprivredu i šumarstvo, zamjenjujući prethodne stupnjeve emisija onečišćujućih tvari iz motora utvrđene Delegiranom uredbom (EU) 2015/96.
The necessary technical requirements concerning in particular engine categories, limit values and implementation dates in this Regulation, should be aligned to the ones in Regulation (EU) 2016/1628.
Potrebni tehnički zahtjevi koji se posebice odnose na kategorije motora, granične vrijednosti i datume provedbe u ovoj Uredbi trebali bi biti usklađeni s onima iz Uredbe (EU) 2016/1628.
That possibility is provided for in Regulation (EU) No 167/2013.
Ta je mogućnost predviđena Uredbom (EU) br. 167/2013.