natgillin/translations-raw huggingface dataset:
it is not related to an exporter or producer subject to the measures imposed by that Regulation; and
nije povezana s izvoznicima ili proizvođačima na koje se primjenjuju mjere uvedene tom uredbom; i
it has either actually exported the goods concerned or has entered into an irrevocable contractual obligation to export a significant quantity to the Union after the end of the period of investigation.
doista je izvozila predmetne proizvode ili je preuzela neopozivu ugovornu obvezu izvoza znatne količine tih proizvoda u Uniju nakon razdoblja ispitnog postupka.
Following the publication of Implementing Regulation (EU) 2015/1518, an American company, Organic Technologies (‘the applicant’), came forward claiming that it met all three criteria set out in recital 6 and should be granted new exporting producer treatment.
Nakon objave Provedbene uredbe (EU) 2015/1518 američko društvo Organic Technologies („podnositelj zahtjeva”) javilo se s tvrdnjom da ispunjava sva tri kriterija iz uvodne izjave (6) te bi mu se stoga trebao odobriti tretman novog proizvođača izvoznika.
The applicant provided information and supporting evidence in response to a questionnaire from the Commission.
Kao odgovor na upitnik koji mu je poslala Komisija podnositelj zahtjeva dostavio je informacije i popratne dokaze.
After an initial analysis of the questionnaire response, the Commission sent the applicant a letter requesting further information.
Nakon početne analize odgovora na upitnik Komisija je podnositelju zahtjeva poslala dopis u kojem traži dodatne informacije.
The applicant responded.
Podnositelj zahtjeva odgovorio je na dopis.
As for criterion (a), the applicant claimed that it existed during the original investigation period.
U pogledu kriterija (a) podnositelj zahtjeva tvrdio je da je postojao tijekom razdoblja početnog ispitnog postupka.
It also claimed that it started to produce biodiesel in 2009, that is, after the original investigation period.
Tvrdio je i da je počeo proizvoditi biodizel 2009., tj. nakon razdoblja početnog ispitnog postupka.
The Commission verified the sales ledgers provided by the applicant.
Komisija je provjerila knjigu izlaznih računa koju je dostavio podnositelj zahtjeva.
Hence, the applicant complies with criterion (a).
Stoga podnositelj zahtjeva ispunjava kriterij (a).
With regard to the criterion (b), namely that the applicant is not related to an exporter or producer subject to anti-dumping measures imposed by Implementing Regulation (EU) 2015/1518, the Commission established, on the basis of the documents submitted by the applicant, that the applicant does not have any related companies which are subject to the measures.
U pogledu kriterija (b), odnosno uvjeta nepovezanosti podnositelja zahtjeva s izvoznicima ili proizvođačima na koje se primjenjuju antidampinške mjere uvedene Uredbom (EU) 2015/1518, Komisija je na temelju dokumenata koje je dostavio podnositelj zahtjeva utvrdila da potonji nije povezan ni s jednim društvom na koje se primjenjuju takve mjere.
Therefore, the applicant complies with criterion (b).
Stoga podnositelj zahtjeva ispunjava kriterij (b).
Therefore, the applicant complies with criterion (c).
Stoga podnositelj zahtjeva ispunjava kriterij (c).
Consequently, the Commission concluded that the applicant meets the three criteria to be considered as a new exporting producer.
Stoga je Komisija zaključila da podnositelj zahtjeva ispunjava tri kriterija koja je potrebno ispuniti kako bi ga se smatralo novim proizvođačem izvoznikom.
Therefore, its name should be added to the list of cooperating companies not included in the sample in Annex I to Implementing Regulation (EU) 2015/1518.
Stoga bi njegov naziv trebalo dodati na popis društava izvan uzorka koja surađuju iz Priloga I. Provedbenoj uredbi (EU) 2015/1518.
Therefore, Commission Implementing Regulation (EU) 2015/1518 should be amended accordingly.
Provedbenu uredbu Komisije (EU) 2015/1518 trebalo bi stoga na odgovarajući način izmijeniti.
The Commission informed the applicant and the Union industry of these findings and gave an opportunity to comment.
Komisija je obavijestila podnositelja zahtjeva i industriju Unije o navedenim nalazima i dala im priliku da se očituju.
The Commission received no comments.
Komisija nije zaprimila nikakve primjedbe.
In Annex I to Commission Implementing Regulation (EU) 2015/1518 the following company shall be added to the list of exporting producers from the United States of America:
Na popis proizvođača izvoznika iz Sjedinjenih Američkih Država u Prilogu I. Provedbenoj uredbi Komisije (EU) 2015/1518 dodaje se sljedeće društvo:
‘Organic Technologies
„Organic Technologies
Commission Implementing Regulation (EU) 2017/1598 of 22 September 2017 amending Commission Implementing Regulation (EU) 2015/1518 imposing a definitive anti-dumping duty on imports of biodiesel originating in the United States of America following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009 (OJ L 245, 23.9.2017, p. 1)
Provedbena uredba Komisije (EU) 2017/1598 оd 22. rujna 2017. o izmjeni Provedbene uredbe (EU) 2015/1518 o uvođenju konačne antidampinške pristojbe na uvoz biodizela podrijetlom iz Sjedinjenih Američkih Država nakon revizije zbog predstojećeg isteka mjera u skladu s člankom 11. stavkom 2. Uredbe Vijeća (EZ) br. 1225/2009 (SL L 245, 23.9.2017., str. 1.).
The applicant showed that it started production of biodiesel in 2009 and the first sales outside of the USA took place only in 2016.
Podnositelj zahtjeva dokazao je da je počeo proizvoditi biodizel 2009. i da je prva prodaja izvan SAD-a ostvarena tek 2016.
Therefore, the Commission accepted that the applicant did not export biodiesel to the Union during the original investigation period.
Stoga je Komisija prihvatila tvrdnju da podnositelj zahtjeva nije izvozio biodizel u Uniju tijekom razdoblja početnog ispitnog postupka.
With regard to the criterion (c), the Commission also established that the applicant had entered into an irrevocable contractual obligation to export a significant quantity of the product concerned to the Union in 2018.
U pogledu kriterija (c) Komisija je utvrdila da je podnositelj zahtjeva preuzeo neopozivu ugovornu obvezu izvoza znatne količine predmetnog proizvoda u Uniju u 2018.
In that respect, the applicant provided a sales contract for the delivery of the product concerned in 2018, which satisfied this criterion.
S tim u vezi podnositelj zahtjeva dostavio je ugovor o prodaji za isporuku predmetnog proizvoda u 2018., čime je ispunjen navedeni kriterij.
Commission Implementing Regulation (EU) 2018/1122
Provedbena uredba Komisije (EU) 2018/1122
authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
o odobravanju stavljanja na tržište dinatrijeve soli pirolokinolin kinona kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
Uredbom (EU) 2015/2283 predviđeno je da se samo nova hrana odobrena i uvrštena na Unijin popis smije stavljati na tržište u Uniji.
Pursuant to Article 8 of Regulation (EU) 2015/2283 the Commission Implementing Regulation (EU) 2017/2470 was adopted, which establishes a Union list of authorised novel foods.
Na temelju članka 8. Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.
Na temelju članka 12. Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
On 6 December 2012, the company Mitsubishi Gas Chemical Company, Inc. (‘the Applicant’) made a request to the competent authority of Ireland to place pyrroloquinoline quinone disodium salt produced from the bacterium Hyphomicrobium denitrificans, on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council.
Društvo Mitsubishi Gas Chemical Company, Inc. („podnositelj zahtjeva”) podnijelo je 6. prosinca 2012. nadležnom tijelu Irske zahtjev za stavljanje na tržište Unije dinatrijeve soli pirolokinolin kinona proizvedene od bakterije Hyphomicrobium denitrificans kao novog sastojka hrane u smislu članka 1. stavka 2. točke (c) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
The application requests for pyrroloquinoline quinone disodium salt to be used in food supplements for the general adult population, excluding pregnant and lactating women.
Zahtjevom se tražilo odobrenje uporabe dinatrijeve soli pirolokinolin kinona u dodacima prehrani za opću populaciju odraslih, osim trudnica i dojilja.
Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.
U skladu s člankom 35. stavkom 1. Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište Unije koji su podneseni državi članici u skladu s člankom 4. Uredbe (EZ) br. 258/97 o novoj hrani i sastojcima nove hrane i za koje nije donesena konačna odluka prije 1. siječnja 2018. tretiraju se kao zahtjevi podneseni u skladu s Uredbom (EU) 2015/2283.
While the request for placing pyrroloquinoline quinone disodium salt on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.
Zahtjev za stavljanje na tržište Unije dinatrijeve soli pirolokinolin kinona kao nove hrane podnesen je državi članici u skladu s člankom 4. Uredbe (EZ) br. 258/97, a ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
On 8 July 2016, the competent authority of Ireland issued its initial assessment report.
Nadležno tijelo Irske izdalo je 8. srpnja 2016. izvješće o početnoj procjeni.
In that report, it came to the conclusion that an additional assessment is required for pyrroloquinoline quinone disodium salt with regards to its safety following long-term consumption at the levels proposed in the application, in accordance with Article 6(3) of Regulation (EC) No 258/97.
U tom je izvješću zaključilo da je potrebna dodatna procjena dinatrijeve soli pirolokinolin kinona u pogledu njezine sigurnosti nakon dugotrajne konzumacije na razinama predloženima u zahtjevu, u skladu s člankom 6. stavkom 3. Uredbe (EZ) br. 258/97.
On 2 August 2016, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 2. kolovoza 2016. izvješće o početnoj procjeni proslijedila ostalim državama članicama.
The Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 agreed with the initial assessment report of Ireland.
Države članice su se u propisanom roku od 60 dana iz članka 6. stavka 4. prvog podstavka Uredbe (EZ) br. 258/97 složile s izvješćem o početnoj procjeni koje je izdala Irska.
In view of the initial assessment report conclusions issued by Ireland, to which the other Member States agreed, on 13 October 2016, the Commission consulted the European Food Safety Authority (‘the Authority’) asking it to carry out an additional assessment for pyrroloquinoline quinone disodium salt as a novel food ingredient in accordance with Regulation (EC) No 258/97.
S obzirom na zaključke početnog izvješća o procjeni koje je izdala Irska i s kojim su se druge države članice složile, Komisija je 13. listopada 2016. zatražila od Europske agencije za sigurnost hrane („Agencija”) da provede dodatnu procjenu dinatrijeve soli pirolokinolin kinona kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97.
On 24 October 2017, the Authority adopted ‘Scientific Opinion on the safety of pyrroloquinoline quinone disodium salt as a novel food pursuant to Regulation (EC) No 258/97’.
Agencija je 24. listopada 2017. donijela „Znanstveno mišljenje o sigurnosti dinatrijeve soli pirolokinolin kinona kao nove hrane u skladu s Uredbom (EZ) br. 258/97”.
This opinion, although elaborated and adopted by the Authority under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Iako je Agencija to mišljenje izradila i donijela na temelju Uredbe (EZ) br. 258/97, ono je u skladu sa zahtjevima iz članka 11. Uredbe (EU) 2015/2283.
That opinion gives sufficient grounds to establish that pyrroloquinoline quinone disodium salt in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.
U mišljenju se iznosi dovoljno informacija na temelju kojih se može utvrditi da je dinatrijeva sol pirolokinolin kinona u okviru predloženih uporaba i razina uporabe, ako se upotrebljava kao sastojak u dodacima prehrani, u skladu s člankom 12. stavkom 1. Uredbe (EU) 2015/2283.
On 24 January 2018, the Applicant made a request to the Commission for protection of proprietary data for a number of studies submitted in support of the application namely, a bacterial reverse mutation test study, an in vitro chromosomal aberration test in human blood lymphocytes study, an in vitro chromosomal aberration test in Chinese hamster lung fibroblasts study, an in vivo micronucleus test study, a 14-day oral toxicity and a 90-day oral toxicity studies, and a 28-day renal toxicity study.
Dana 24. siječnja 2018. podnositelj zahtjeva Komisiji je podnio zahtjev za zaštitu vlasničkih podataka povezanih s nizom studija provedenih u potporu zahtjevu, i to studijom o bakterijskom testu povratnih mutacija, studijom o in vitro ispitivanju kromosomskih aberacija limfocita u ljudskoj krvi, studijom o in vitro ispitivanju kromosomskih aberacija fibroblasta pluća kineskog hrčka, studijom o mikronukleus testu in vivo, 14-dnevnom i 90-dnevnom studijom oralne toksičnosti te 28-dnevnom studijom renalne toksičnosti.
On 18 February 2018, the Authority considered that in elaborating its opinion on pyrroloquinoline quinone disodium salt as a novel food, the data from the bacterial reverse mutation test and from the in vivo micronucleus test studies served as basis to alleviate concerns with respect to the potential genotoxity of pyrroloquinoline quinone disodium salt, and the 14-day oral, the 28-day renal toxicity, and the 90-day oral toxicity studies served as a basis to assess the toxicity profile of pyrroloquinoline quinone disodium salt and to establish the related No Observed Adverse Effect Level (NOAEL).
Agencija je 18. veljače 2018. navela da su u obrazloženju njezina mišljenja o dinatrijevoj soli pirolokinolin kinona kao novoj hrani podaci iz studije o bakterijskom testu povratnih mutacija i studije o mikronukleus testu in vivo služili kao osnova za ublažavanje zabrinutosti u pogledu potencijalne genotoksičnosti dinatrijeve soli pirolokinolin kinona, te da su podaci iz 14-dnevne studije oralne toksičnosti, 28-dnevne studije renalne toksičnosti i 90-dnevne studije oralne toksičnosti služili kao osnova za procjenu profila toksičnosti dinatrijeve soli pirolokinolin kinona i utvrđivanje povezane razine bez opaženog štetnog učinka (NOAEL).
Therefore, it is considered that the conclusions on the safety of pyrroloquinoline quinone disodium salt, could not have been reached without the data from the unpublished reports of these studies.
Stoga se smatra da zaključci o sigurnosti dinatrijeve soli pirolokinolin kinona nisu mogli biti doneseni bez podataka iz neobjavljenih izvješća o tim studijama.
Following the receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the study reports, which were unpublished at the time the application was made, and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(a)(b) of Regulation (EU) 2015/2283.
Nakon primitka mišljenja Agencije Komisija je zatražila od podnositelja zahtjeva da dodatno pojasni obrazloženje s obzirom na njegov zahtjev za zaštitu vlasničkih podataka iz izvješća o studijama, koje u trenutku podnošenja zahtjeva nisu bile objavljene, kao i da pojasni zahtjev za isključivo pravo upućivanja na te studije, kako je navedeno u članku 26. stavku 2. točkama (a) i (b) Uredbe (EU) 2015/2283.
The Applicant has also declared that, at the time the application was submitted, they held proprietary or exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies.
Podnositelj zahtjeva tvrdio je i da je u vrijeme podnošenja zahtjeva bio nositelj vlasničkih i isključivih prava upućivanja na studije u skladu s nacionalnim pravom te da stoga treća strana nije mogla imati zakonit pristup tim studijama niti se koristiti njima.
The Commission assessed all the information provided by the Applicant and considered that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.
Komisija je ocijenila sve podatke koje je dostavio podnositelj zahtjeva te zaključila da je podnositelj zahtjeva dostatno obrazložio ispunjavanje zahtjeva utvrđenih u članku 26. stavku 2. Uredbe (EU) 2015/2283.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the bacterial reverse mutation test, the in vivo micronucleus test studies, the 14-day oral toxicity, the 28-day renal toxicity, and the 90-day oral toxicity studies contained in the Applicant's file should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation.
U skladu s tim, kako je predviđeno člankom 26. stavkom 2. Uredbe (EU) 2015/2283, Agencija ne bi smjela upotrijebiti bakterijski test povratnih mutacija, studiju o mikronukleus testu in vivo, 14-dnevnu studiju oralne toksičnosti, 28-dnevnu studiju renalne toksičnosti i 90-dnevnu studiju oralne toksičnosti iz dosjea podnositelja zahtjeva u korist budućeg podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe.
As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.
Slijedom toga, stavljanje na tržište Unije nove hrane odobrene u skladu s ovom Uredbom trebalo bi ograničiti na podnositelja zahtjeva na razdoblje od pet godina.
However, restricting the authorisation of this novel food and of the reference to the studies contained in the Applicant's file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation.
Međutim, ograničenje odobrenja te nove hrane i upućivanje na studije iz dosjea podnositelja zahtjeva isključivo za potrebe podnositelja zahtjeva ne sprečava ostale podnositelje zahtjeva da zatraže odobrenje za stavljanje na tržište te iste nove hrane, uz uvjet da se njihov zahtjev temelji na zakonito pribavljenim informacijama kojima se podupire odobrenje u skladu s ovom Uredbom.
Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing pyrroloquinoline quinone disodium salt should be appropriately labelled.
Uzimajući u obzir predviđenu uporabu u dodacima prehrani za opću populaciju odraslih i činjenicu da zahtjev za odobrenje isključuje trudnice i dojilje, dodatke prehrani koji sadržavaju dinatrijevu sol pirolokinolin kinona trebalo bi u tom pogledu na odgovarajući način označiti.
The use of pyrroloquinoline quinone disodium salt should be authorised without prejudice to that Directive.
Uporabu dinatrijeve soli pirolokinolin kinona trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
Pyrroloquinoline quinone disodium salt as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
Dinatrijeva sol pirolokinolin kinona, kako je navedeno u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen Provedbenom uredbom (EU) 2017/2470.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
U razdoblju od pet godina od dana stupanja na snagu ove Uredbe odobrava se isključivo podnositelju zahtjeva:
Company: Mitsubishi Gas Chemical Company, Inc.
društvu: Mitsubishi Gas Chemical Company, Inc.
Address: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
adresa: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan ;
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Mitsubishi Gas Chemical Company, Inc.
stavljanje na tržište Unije nove hrane iz stavka 1., osim ako budući podnositelj zahtjeva dobije odobrenje za novu hranu bez upućivanja na podatke zaštićene u skladu s člankom 2. ove Uredbe ili uz suglasnost društva Mitsubishi Gas Chemical Company, Inc.
The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
Unos na popis Unije iz prvog stavka uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the data protection could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Mitsubishi Gas Chemical Company, Inc.
Studije iz dosjea podnositelja zahtjeva na temelju kojih je Agencija provela ocjenu nove hrane iz članka 1., na koju podnositelj zahtjeva polaže vlasnička prava i bez kojih zaštita podataka ne bi bila odobrena, ne smiju se upotrijebiti u korist budućih podnositelja zahtjeva u razdoblju od pet godina od datuma stupanja na snagu ove Uredbe bez suglasnosti društva Mitsubishi Gas Chemical Company, Inc.
EFSA Journal 2017; 15(11):5058.
EFSA Journal 2017.; 15(11):5058.
Mitsubishi Gas Chemical Company Inc., 2005b (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2005b (neobjavljeno izvješće).
Mitsubishi Gas Chemical Company Inc., 2008b (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2008b (neobjavljeno izvješće).
Mitsubishi Gas Chemical Company Inc., 2006d (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2006d (neobjavljeno izvješće).
Mitsubishi Gas Chemical Company Inc., 2006c (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2006c (neobjavljeno izvješće).
Mitsubishi Gas Chemical Company Inc., 2005a (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2005a (neobjavljeno izvješće).
Mitsubishi Gas Chemical Company Inc., 2006b (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2006b (neobjavljeno izvješće).