natgillin/translations-raw huggingface dataset:
OJ L 354, 31.12.2008, p. 1.
SL L 354, 31.12.2008., str. 34.
Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).
SL L 354, 31.12.2008., str. 1.
Commission Regulation (EU) No 873/2012 of 1 October 2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (OJ L 267, 2.10.2012, p. 162).
Provedbena uredba Komisije (EU) br. 872/2012 od 1. listopada 2012. o donošenju popisa aromatičnih tvari utvrđenih Uredbom (EZ) br. 2232/96 Europskog parlamenta i Vijeća, o njegovom unošenju u Prilog I. Uredbi (EZ) br. 1334/2008 Europskog parlamenta i Vijeća i o stavljanju izvan snage Uredbe Komisije (EZ) br. 1565/2000 i Odluke Komisije 1999/217/EZ (SL L 267, 2.10.2012., str. 1.).
EFSA Journal 2017;15(8):4897.
Uredba Komisije (EU) br. 873/2012 od 1. listopada 2012. o prijelaznim mjerama koje se odnose na Unijin popis aroma i sirovina utvrđen u Prilogu I. Uredbi (EZ) br. 1334/2008 Europskog parlamenta i Vijeća (SL L 267, 2.10.2012., str. 162.).
ANNEX
EFSA Journal 2017.;15(8):4897.
In Part E of Annex I to Regulation (EC) No 1334/2008 the following entry concerning pyroligneous distillate [FL no: 21.001] is added:
PRILOG
FL no.
U dijelu E Priloga I. Uredbi (EZ) br. 1334/2008 dodaje se sljedeći unos koji se odnosi na piroligninski destilat [FL br.: 21.001]:
Name
FL br.
CAS no
Naziv
JECFA No.
CAS br.
CoE No.
JECFA br.
Purity of the named flavouring
CoE br.
Restrictions of use
Čistoća navedene arome
Footnote
Ograničenja upotrebe
Reference
Bilješka
Pyroligneous distillate
Referentno tijelo
Complex mixture of substances, obtained by distillation of reaction products of pyroligneous acid and ethanol.
Piroligninski destilat
Liquid with rum-like tasting odour and taste.
Složena smjesa sastojaka dobivenih destilacijom produkata reakcije piroligninske kiseline i etanola.
Constituents:
Tekućina čiji miris i okus podsjećaju na rum.
Ethanol (determined by Gas Chromatography/Flame Ionization Detector): more than 40 % w/w)
Sastojci:
Ethyl acetate: less than 25 % w/w)
etanol (utvrđeno plinskom kromatografijom/ionizacijskim detektorom plamena): više od 40 % masenog udjela
Ethyl formate: less than 2 % w/w)
etil-acetat: manje od 25 % masenog udjela
Ethyl propionate: less than 4 % w/w)
etil-formijat: manje od 2 % masenog udjela
Ethyl butyrate: less than 1,5 % w/w)
etil-propionat: manje od 4 % masenog udjela
Methyl acetate: less than 3,5 % w/w)
etil-butirat: manje od 1,5 % masenog udjela
Furan equivalents (furan and 2 methyl furan) expressed as furan: less than 8 mg/l
metil-acetat: manje od 3,5 % masenog udjela
Methanol and methanol derivatives, expressed as methanol equivalents: less than 2 % (w/w)
ekvivalenti furana (furan i 2-metil-furan) izraženi kao furan: manje od 8 mg/l
Benzopyrene: less than 1 μg/l
metanol i derivati metanola, izraženi kao ekvivalenti metanola: manje od 2 % masenog udjela
Benz(a)anthra-cene: less than 2 μg/l
benzopiren: manje od 1 μg/l
acids (expressed as acetic acid): less than 1,00 g/l
benz(a)antracen: manje od 2 μg/l
In the following spirit drinks only:
kiseline (izražene kao octena kiselina): manje od 1,00 g/l
tuzemák and tuzemský falling under Regulation (EC) No 110/2008 when marketed in the final package intended only for the final consumer, 3800 mg/l.
Samo u sljedećim jakim alkoholnim pićima:
When reference is made in the labelling to the flavouring pyroligneous distillate [FL no: 21.001] in the spirit drinks tuzemák and tuzemský, the name or the FL number shall be used.
tuzemák i tuzemský na koje se primjenjuje Uredba (EZ) 110/2008 kad se stavljaju na tržište u konačnom pakiranju namijenjenom samo krajnjem potrošaču, 3800 mg/l.
Tuzemák and tuzemský to which pyroligneous distillate [FL no: 21.001] has been added shall not be used in the manufacture of other foodstuffs.
Kad se pri označivanju spominje aroma piroligninski destilat [FL br.: 21.001] u jakim alkoholnim pićima tuzemák i tuzemský, navodi se naziv ili FL broj.
In addition to the requirements of Article 15 of Regulation (EC) No 1334/2008, when this flavouring is marketed as such, it shall be indicated in the labelling that this flavouring may only be used for the manufacture of the spirit drinks tuzemák and tuzemský.
Tuzemák i tuzemský kojima je dodan piroligninski destilat [FL br.: 21.001] ne smiju se upotrebljavati se u proizvodnji druge hrane.
Member States shall require additional labelling, informing consumers about the specific risks linked to the presence of pyroligneous distillate [FL no. 21.001] in the spirit drinks tuzemák and tuzemský.
Uz zahtjeve iz članka 15.
EFSA’
Uredbe (EZ) br. 1334/2008, kad se ta aroma kao takva stavlja na tržište, pri označivanju se navodi da se ta aroma smije upotrebljavati samo za proizvodnju jakih alkoholnih pića tuzemák i tuzemský.
Regulation (EU) No 872/2012 also introduced Part B (‘Flavouring preparations’), Part C (‘Thermal process flavourings’), Part D (‘Flavour precursors’), Part E (‘Other flavourings’) and Part F (‘Source materials’) in Annex I to Regulation (EC) No 1334/2008.
Agencija je 24. kolovoza 2017. donijela „Znanstveno mišljenje o ocjeni skupine aroma 500 (FGE.500): „eter ruma” (Scientific Opinion of Flavouring Group Evaluation 500 (FGE.500): rum ether), koje se odnosi na ocjenu sigurnosti piroligninskog destilata [FL br. 21.001] kada se upotrebljava kao aroma pod kategorijom „ostale arome”.
Commission Delegated Regulation (EU) 2018/1253
Delegirana uredba Komisije (EU) 2018/1253
correcting Delegated Regulation (EU) 2016/2374 establishing a discard plan for certain demersal fisheries in South-Western waters
o izmjeni Delegirane uredbe (EU) 2016/2374 o uspostavi plana za odbačeni ulov za ribolov određenih pridnenih vrsta u jugozapadnim vodama
Having regard to Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC, and in particular Articles 15(6) and 18(1) and (3) thereof,
uzimajući u obzir Uredbu (EU) br. 1380/2013 Europskog parlamenta i Vijeća od 11. prosinca 2013. o zajedničkoj ribarstvenoj politici, izmjeni uredaba Vijeća (EZ) br. 1954/2003 i (EZ) br. 1224/2009 i stavljanju izvan snage uredaba Vijeća (EZ) br. 2371/2002 i (EZ) br. 639/2004 i Odluke Vijeća 2004/585/EZ, a posebno njezin članak 15. stavak 6. i članak 18. stavke 1. i 3.,
Regulation (EU) No 1380/2013 aims to progressively eliminate discards in all Union fisheries through the introduction of a landing obligation for catches of species subject to catch limits.
Uredba (EU) br. 1380/2013 za cilj ima postupno napuštanje prakse odbacivanja ulova u svim vrstama ribolova Unije uvođenjem obveze iskrcavanja ulova za vrste koje podliježu ograničenjima ulova.
In order to implement the landing obligation, Article 15(6) of Regulation (EU) No 1380/2013 empowers the Commission to adopt discard plans by means of a delegated act on the basis of joint recommendations developed by Member States in consultation with the relevant Advisory Councils.
U cilju provedbe obveze iskrcavanja Komisiji su člankom 15. stavkom 6.
Commission Delegated Regulation (EU) 2016/2374 established a discard plan for certain demersal fisheries in South-Western waters following a joint recommendation submitted by Belgium, France, the Netherlands, Portugal and Spain (The South Western Waters Group) in 2016.
Uredbe (EU) br. 1380/2013 dodijeljene ovlasti za donošenje planova za odbačeni ulov delegiranim aktom na temelju zajedničkih preporuka koje izrađuju države članice uz savjetovanje s relevantnim savjetodavnim vijećima.
On 2 June 2017 Belgium, France, the Netherlands, Portugal and Spain have submitted a new joint recommendation suggesting a number of amendments to the discard plan.
Na temelju zajedničke preporuke koju su 2016. dostavile Belgija, Francuska, Nizozemska, Portugal i Španjolska, i („Skupina jugozapadne vode”), Delegiranom uredbom Komisije (EU) 2016/2374 uspostavljen je plan za odbačeni ulov za ribolov određenih pridnenih vrsta u jugozapadnim vodama.
Based on that, the Commission adopted Delegated Regulation (EU) 2018/44 amending Delegated Regulation (EU) 2016/2374.
Belgija, Francuska, Nizozemska, Portugal i Španjolska dostavile su 2. lipnja 2017. novu zajedničku preporuku u kojoj predlažu niz izmjena plana za odbačeni ulov.
On 26 October 2017 the South Western Waters Group communicated to the Commission the existence of a textual error in the Annex to Delegated Regulation (EU) 2018/44 as regards the description of hake fisheries subject to the landing obligation.
Na temelju toga Komisija je donijela Delegiranu uredbu (EU) 2018/44 o izmjeni Delegirane uredbe (EU) 2016/2374.
According to the current version of that Annex, hake fisheries carried out in ICES (International Council for the Exploration of the Seas) divisions VIIIc and IXa with bottom trawls and seines are subject to the landing obligation if the total hake landings in the period 2014/2015 exceeded 5 % of all landed species and more than 5 metric tons.
Dana 26. listopada 2017. „Skupina jugozapadne vode” obavijestila je Komisiju o postojanju pogreške u tekstu u Prilogu Delegiranoj uredbi (EU) 2018/44 u opisu ribolova oslića koji podliježe obvezi iskrcavanja.
That condition however is no longer applicable.
Prema sadašnjoj verziji tog priloga ribolov oslića koji se provodi u zonama ICES-a (Međunarodno vijeće za istraživanje mora) VIII.c i IX.a pridnenim povlačnim mrežama (koćama) i mrežama potegačama podliježe obvezi iskrcavanja ako je ukupni iskrcani ulov oslića u razdoblju 2014.–2015. činio više od 5 % svih iskrcanih vrsta i više od 5 metričkih tona.
There is therefore a need to correct Delegated Regulation (EU) 2016/2374 as amended by Delegated Regulation (EU) 2018/44.
Taj uvjet međutim više nije primjenjiv.
Since the textual error in the Annex to Delegated Regulation (EU) 2016/2374 has been introduced by Delegated Regulation (EU) 2018/44, and in order to avoid any discontinuity and legal uncertainty in the application of the landing obligation, this Regulation should enter into force on the day following that of its publication and should apply retroactively from the date of application of Delegated Regulation (EU) 2018/44,
Delegiranu uredbu (EU) 2016/2374 kako je izmijenjena Delegiranom uredbom (EU) 2018/44 stoga je potrebno ispraviti.
HAS ADOPTED THIS REGULATION:
Budući da je pogreška u tekstu u Prilogu Delegiranoj uredbi (EU) 2016/2374 uvedena Delegiranom uredbom (EU) 2018/44 te kako bi se izbjegli diskontinuitet i pravna nesigurnost u primjeni obveze iskrcavanja, ova Uredba trebala bi stupiti na snagu sljedećeg dana od dana objave i trebala bi se primjenjivati retroaktivno od datuma primjene Delegirane uredbe (EU) 2018/44,
In the fourth column of the table ‘3.
Članak 1.
Hake (Merluccius merluccius) fisheries’ of the Annex to Delegated Regulation (EU) 2016/2374 the text:
U četvrtom stupcu tablice „3.
‘Vessels which fulfil the following cumulative criteria:
Ribolov oslića (Merluccius merluccius)” u Prilogu Delegiranoj uredbi (EU) 2016/2374, tekst:
Use mesh size larger or equal to 70 mm
„Plovila koja ispunjavaju sve sljedeće kriterije:
Total hake landings in the period 2014/2015 (1) consist of: more than 5 % of all landed species and more than 5 metric tons.’
Koriste se veličinom oka od 70 mm ili većom.
is replaced by the following:
Ukupni iskrcani ulov oslića u razdoblju 2014. – 2015.
‘Use mesh size larger or equal to 70 mm’.
čini: više od 5 % svih iskrcanih vrsta i više od 5 metričkih tona.”; zamjenjuje se sljedećim:
Article 2
„Koriste se veličinom oka od 70 mm ili većom.”
It shall apply from 1 January 2018.
Ova Uredba stupa na snagu sljedećeg dana od dana objave u Službenom listu Europske unije.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Primjenjuje se od 1. siječnja 2018.
Done at Brussels, 28 June 2018.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
For the Commission
Sastavljeno u Bruxellesu 28. lipnja 2018.
OJ L 354, 28.1.2013, p. 22.
Predsjednik
Commission Delegated Regulation (EU) 2016/2374 of 12 October 2016 establishing a discard plan for certain demersal fisheries in South-Western waters (OJ L 352, 23.12.2016, p. 33.)
SL L 354, 28.1.2013., str. 22.
concerning the denial of authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect
o uskraćivanju odobrenja riboflavina (80 %) dobivenog od Bacillus subtilis KCCM-10445 kao dodatka hrani za životinje koji pripada funkcionalnoj skupini vitamina, provitamina i kemijski točno definiranih tvari sličnog učinka
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisation.
Uredbom (EZ) br. 1831/2003 propisuje se odobravanje dodataka hrani za životinje te osnove i postupci za izdavanje ili uskraćivanje tog odobrenja.
That product 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 proizvod nakon toga unesen 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 thereof, an application was submitted for the authorisation of riboflavin, with a purity of minimum 80 %, produced by the genetically modified strain Bacillus subtilis KCCM-10445, as a feed additive for all animal species.
Uredbe (EZ) br. 1831/2003.
The applicant requested that the additive be classified in the additive category ‘nutritional additives’.
U skladu s člankom 10. stavkom 2.
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 u vezi s njezinim člankom 7., podnesen je zahtjev za odobrenje riboflavina minimalne čistoće od 80 %, dobivenog od genetski modificiranih sojeva Bacillus subtilis KCCM-10445, kao dodatka hrani za sve životinjske vrste.
In 2010, in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003 and Article 3 of Commission Regulation (EC) No 378/2005, the applicant sent samples of the feed additive, in a form in which the feed additive was intended to be placed on the market, to the Reference Laboratory under Regulation (EC) No 1831/2003 (‘the Reference Laboratory’).
Podnositelj zahtjeva zatražio je da se dodatak razvrsta u kategoriju dodataka „nutritivni dodaci”.
In 2013, in accordance with Article 3(3) of Regulation (EC) No 378/2005, the applicant supplied the Reference Laboratory with new samples to replace those expired.
Uz navedeni zahtjev priloženi su podaci i dokumenti propisani člankom 7. stavkom 3.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 December 2013 that neither the production strain nor its recombinant DNA (‘rDNA’) was detected in the final product having regard to the information provided by the applicant and that therefore, the final product did not raise any safety concern with regard to the genetic modification of the production strain.
Uredbe (EZ) br. 1831/2003.
It was also concluded that the additive did not have an adverse effect on animal health, human health or the environment.
Godine 2010., u skladu s člankom 7. stavkom 3. točkom (f) Uredbe (EZ) br. 1831/2003 i člankom 3.
However, the Commission was informed by the Reference Laboratory that, in the context of an official control performed by a national competent authority, the presence of viable cells and of rDNA from the production strain was detected in some reference samples of the additive by a national laboratory competent for official controls.
Uredbe Komisije (EZ) br. 378/2005, podnositelj zahtjeva poslao je referentnom laboratoriju iz Uredbe (EZ) br. 1831/2003 („referentni laboratorij”) uzorke dodatka hrani za životinje u obliku u kojem se namjeravao staviti na tržište.
Such detection resulted from the use of a polymerase chain reaction (‘PCR’) analysis method developed by a national laboratory competent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004 of the European Parliament and of the Council.
Uredbe (EZ) br. 378/2005, podnositelj zahtjeva dostavio je referentnom laboratoriju nove uzorke kao zamjenu za one kojima je istekao rok.
The Commission and the Reference Laboratory informed the applicant on those findings and gave him the opportunity to provide a suitable method of analysis both for the detection of rDNA and for the presence of viable cells from the production strain in order to proceed to further analysis of various samples of the additive.
Europska agencija za sigurnost hrane („Agencija”) u svojem je mišljenju od 4. prosinca 2013. zaključila da proizvodni soj i njegova rekombinantna DNK („rDNK”) nisu otkriveni u konačnom proizvodu s obzirom na informacije koje je dostavio podnositelj zahtjeva i da stoga za konačni proizvod nije utvrđen razlog za zabrinutost u vezi s genetskom modifikacijom proizvodnog soja.
For that purpose, the applicant requested several laboratories, established both in China and in a Member State, to perform new analyses of the samples.
Također je zaključeno da dodatak nema štetan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš.
The results of those analyses were negative as regards the detection of both rDNA and viable cells from the specific production strain.
Međutim, referentni laboratorij obavijestio je Komisiju da je, u kontekstu službene kontrole koju provodi nacionalno nadležno tijelo, nacionalni laboratorij nadležan za službene kontrole otkrio prisutnost živih stanica i rDNK iz proizvodnog soja u nekim referentnim uzorcima dodatka.
However, it appeared that the new analyses carried out by the applicant did not concern the samples submitted in 2010 to the Reference Laboratory.
Komisija i referentni laboratorij obavijestili su podnositelja zahtjeva o tim nalazima i dali mu mogućnost da osigura prikladnu metodu analize za otkrivanje rDNK i prisutnosti živih stanica iz proizvodnog soja kako bi se nastavilo s daljnjom analizom različitih uzoraka dodatka.
In parallel, at the request of the Commission and the Reference Laboratory, further analyses of the samples of the additive were carried out by a national laboratory competent for official controls.
U tu je svrhu podnositelj zahtjeva zatražio od nekoliko laboratorija, osnovanih u Kini i u državi članici, provedbu novih analiza uzoraka.
That laboratory sent samples to another national laboratory competent for official controls for further analysis, which confirmed the presence of rDNA from the production strain in the samples of 2010 and 2013.
Međutim, činilo se da se nove analize koje je provodio podnositelj zahtjeva nisu odnosile na uzorke koji su 2010. dostavljeni referentnom laboratoriju.
Those results were obtained through the use of a PCR analysis method developed by a national laboratory competent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004.
Istodobno su na zahtjev Komisije i referentnog laboratorija daljnje analize uzoraka dodatka proveli nacionalni laboratoriji nadležni za službene kontrole.
In 2015, in order to resolve the divergence of results, it was agreed between the Commission and the Reference Laboratory on one hand and the applicant on the other hand that each of them would request an independent laboratory accredited for a PCR method to perform further analysis of the additive.
Na temelju toga je zaključeno da su žive stanice iz proizvodnog soja bile prisutne u uzorcima iz 2010. i da je rDNK iz proizvodnog soja bio prisutan u uzorcima iz 2010. i 2013.
It was agreed that both the analytical methods used by the applicant and by the national laboratories competent for official controls would be shared and used.
U tu svrhu koristili bi se uzorci iz 2010. i 2013., a podnositelj zahtjeva bio je pozvan da, među ostalim, dostavi uzorke u obliku u kojem je dodatak bio stavljen na tržište u to vrijeme.
However, the applicant subsequently refused to have the samples submitted in 2010 and 2013 analysed and to provide samples corresponding to the additive placed on the market in 2015.
Dogovoreno je da će se dijeliti i upotrijebiti obje analitičke metode koje je koristio podnositelj zahtjeva i nacionalni laboratoriji nadležan za službene kontrole.
The applicant refused to further cooperate with the Commission and the Reference Laboratory as long as a ‘unified analysis standard’ method for the detection of rDNA in riboflavin was not established under Union legislation.
Na temelju Uredbe (EZ) br. 1831/2003, podnositelj zahtjeva na odgovarajući način i u dovoljnoj mjeri mora dokazati da dodatak ispunjava uvjete za odobrenje utvrđene u toj Uredbi, njezinim provedbenim mjerama i odgovarajućim smjernicama Agencije, osobito podnošenjem odgovarajućih uzoraka dodatka, svih informacija u vezi s genetskom modifikacijom proizvodnog soja, upotrijebljenom metodom koja se temelji na PCR-u, protokolom za ekstrakciju DNK i ostalih relevantnih podataka koji Agenciji omogućuju da utvrdi nepostojanje rDNK ili živih stanica iz proizvodnog soja.
Under Regulation (EC) No 1831/2003, the burden is on the applicant to adequately and sufficiently demonstrate that the additive satisfies the conditions for authorisation laid down in that Regulation, its implementing measures and applicable Authority's guidance, in particular through the submission of relevant samples of the additive, all information related to the genetic modification of the production strain, the PCR-based method used, the protocol for extraction of the DNA and other relevant data allowing the Authority to determine the absence of rDNA or viable cells from the production strain.
Na temelju tih podataka koji ukazuju na prisutnost živih stanica i rDNK iz proizvodnog soja u dodatku, Komisija je u kolovozu 2016. zatražila od Agencije da dostavi novo mišljenje o sigurnosti riboflavina (80 %) dobivenog iz genetski modificiranog soja Bacillus subtilis KCCM-10445 kao dodatka hrani za sve životinjske vrste.
On the basis of those data indicating the presence of viable cells and rDNA from the production strain in the additive, in August 2016 the Commission requested the Authority to deliver a new opinion on the safety of riboflavin (80 %) produced by the genetically modified strain Bacillus subtilis KCCM-10445 as a feed additive for all animal species.
Kako bi provela svoju procjenu, Agencija je od podnositelja zahtjeva zatražila dostavu dodatnih informacija i podataka koji se posebno odnose na metodu analize za otkrivanje prisutnosti živih stanica proizvodnog soja u tom dodatku.
In order to undertake its assessment, the Authority requested the applicant to provide supplementary information and data, related in particular to the method of analysis for the detection of the presence of viable cells of the production strain in the additive.
Podnositelj zahtjeva dostavio je takve dodatne informacije i podatke.
Such supplementary information and data was submitted by the applicant.
Agencija je od referentnog laboratorija zatražila i dostavu dodatnih informacija i podataka koji se odnose na analize koje su proveli nacionalni laboratoriji nadležni za službene kontrole, koji su isto tako dostavljeni.