natgillin/translations-raw huggingface dataset:
it is not related to an exporter or producer subject to the measures imposed by that Regulation; and
Uredbe (EZ) br. 1225/2009 izvorne mjere produljene su za pet godina Provedbenom uredbom (EU) 2015/1518.
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.
Provedbena uredba (EU) 2015/1518 izmijenjena je Provedbenom uredbom Komisije (EU) 2017/1598 kako bi se uvrstio članak 1. stavak 6., kojim se proizvođačima izvoznicima omogućuje da zatraže tretman novog proizvođača izvoznika.
B. REQUESTS FOR NEW EXPORTING PRODUCER TREATMENT
U članku 1. stavku 6.
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.
Provedbene uredbe (EU) 2015/1518 navodi se da Komisija može izmijeniti Prilog I. kako bi dodijelila pristojbu koja se primjenjuje na proizvođače izvan uzorka koji surađuju, tj.
The applicant provided information and supporting evidence in response to a questionnaire from the Commission.
115,6 EUR po toni neto, svakoj strani iz SAD-a koja Komisiji dostavi dovoljno dokaza da:
After an initial analysis of the questionnaire response, the Commission sent the applicant a letter requesting further information.
nije izvozila biodizel podrijetlom iz SAD-a tijekom razdoblja ispitnog postupka (1. travnja 2007.–31. ožujka 2008.);
The applicant responded.
nije povezana s izvoznicima ili proizvođačima na koje se primjenjuju mjere uvedene tom uredbom; i
As for criterion (a), the applicant claimed that it existed during the original investigation period.
doista je izvozila predmetne proizvode ili je preuzela neopozivu ugovornu obvezu izvoza znatne količine tih proizvoda u Uniju nakon razdoblja ispitnog postupka.
It also claimed that it started to produce biodiesel in 2009, that is, after the original investigation period.
B. ZAHTJEVI ZA TRETMAN NOVOG PROIZVOĐAČA IZVOZNIKA
The Commission verified the sales ledgers provided by the applicant.
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.
Therefore, the Commission accepted that the applicant did not export biodiesel to the Union during the original investigation period.
Nakon početne analize odgovora na upitnik Komisija je podnositelju zahtjeva poslala dopis u kojem traži dodatne informacije.
Hence, the applicant complies with criterion (a).
Podnositelj zahtjeva odgovorio je na dopis.
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 (a) podnositelj zahtjeva tvrdio je da je postojao 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.
Komisija je provjerila knjigu izlaznih računa koju je dostavio podnositelj zahtjeva.
In that respect, the applicant provided a sales contract for the delivery of the product concerned in 2018, which satisfied this criterion.
Stoga podnositelj zahtjeva ispunjava kriterij (a).
Therefore, the applicant complies with criterion (c).
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.
Consequently, the Commission concluded that the applicant meets the three criteria to be considered as a new exporting producer.
Stoga podnositelj zahtjeva ispunjava kriterij (b).
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 podnositelj zahtjeva ispunjava kriterij (c).
Therefore, Commission Implementing Regulation (EU) 2015/1518 should be amended accordingly.
Stoga je Komisija zaključila da podnositelj zahtjeva ispunjava tri kriterija koja je potrebno ispuniti kako bi ga se smatralo novim proizvođačem izvoznikom.
The Commission informed the applicant and the Union industry of these findings and gave an opportunity to comment.
Stoga bi njegov naziv trebalo dodati na popis društava izvan uzorka koja surađuju iz Priloga I. Provedbenoj uredbi (EU) 2015/1518.
The Commission received no comments.
Provedbenu uredbu Komisije (EU) 2015/1518 trebalo bi stoga na odgovarajući način izmijeniti.
This Regulation is in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036,
Komisija je obavijestila podnositelja zahtjeva i industriju Unije o navedenim nalazima i dala im priliku da se očituju.
HAS ADOPTED THIS REGULATION:
Komisija nije zaprimila nikakve primjedbe.
Article 1
Ova je Uredba u skladu s mišljenjem Odbora uspostavljenog člankom 15. stavkom 1.
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:
Uredbe (EU) 2016/1036,
Company name
DONIJELA JE OVU UREDBU:
City
Članak 1.
TARIC additional code
Na popis proizvođača izvoznika iz Sjedinjenih Američkih Država u Prilogu I. Provedbenoj uredbi Komisije (EU) 2015/1518 dodaje se sljedeće društvo:
‘Organic Technologies
Naziv društva
Article 2
Grad
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Dodatna oznaka TARIC
This Regulation shall be binding in its entirety and directly applicable in all Member States.
„Organic Technologies
Done at Brussels, 10 August 2018.
Članak 2.
OJ L 176, 30.6.2016, p. 21.
Sastavljeno u Bruxellesu 10. kolovoza 2018.
Commission Implementing Regulation (EU) 2015/1518 of 14 September 2015 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 239, 15.9.2015, p. 69).
Za Komisiju
Council Regulation (EC) No 599/2009 of 7 July 2009 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of biodiesel originating in the United States of America (OJ L 179, 10.7.2009, p. 26).
Predsjednik
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)
SL L 176, 30.6.2016., str. 21.
The applicant showed that it started production of biodiesel in 2009 and the first sales outside of the USA took place only in 2016.
Provedbena uredba Komisije (EU) 2015/1518 od 14. rujna 2015. 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.
Therefore, the Commission accepted that the applicant did not export biodiesel to the Union during the original investigation period.
Uredbe Vijeća (EZ) br. 1225/2009 (SL L 239, 15.9.2015., str. 69.).
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.
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.
Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
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.
Na temelju članka 12.
The application requests for pyrroloquinoline quinone disodium salt to be used in food supplements for the general adult population, excluding pregnant and lactating women.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
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.
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.
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.
Zahtjevom se tražilo odobrenje uporabe dinatrijeve soli pirolokinolin kinona u dodacima prehrani za opću populaciju odraslih, osim trudnica i dojilja.
On 8 July 2016, the competent authority of Ireland issued its initial assessment report.
U skladu s člankom 35. stavkom 1.
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.
Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište Unije koji su podneseni državi članici u skladu s člankom 4.
On 2 August 2016, the Commission forwarded the initial assessment report to the other Member States.
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.
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.
Zahtjev za stavljanje na tržište Unije dinatrijeve soli pirolokinolin kinona kao nove hrane podnesen je državi članici u skladu s člankom 4.
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.
Uredbe (EZ) br. 258/97, a ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
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’.
Nadležno tijelo Irske izdalo je 8. srpnja 2016. izvješće o početnoj procjeni.
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.
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.
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.
Uredbe (EZ) br. 258/97.
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.
Komisija je 2. kolovoza 2016. izvješće o početnoj procjeni proslijedila ostalim državama članicama.
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).
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.
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.
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.
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.
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”.
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.
Iako je Agencija to mišljenje izradila i donijela na temelju Uredbe (EZ) br. 258/97, ono je u skladu sa zahtjevima iz članka 11.
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.
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 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.
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.
Uredbe (EU) 2015/2283.
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.
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.
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.
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).
Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements.
Stoga se smatra da zaključci o sigurnosti dinatrijeve soli pirolokinolin kinona nisu mogli biti doneseni bez podataka iz neobjavljenih izvješća o tim studijama.
The use of pyrroloquinoline quinone disodium salt should be authorised without prejudice to that Directive.
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 measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
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.
HAS ADOPTED THIS REGULATION:
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.
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.
U skladu s tim, kako je predviđeno člankom 26. stavkom 2.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
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.
Company: Mitsubishi Gas Chemical Company, Inc.
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.
Address: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
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.
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.
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 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.
Direktivom 2002/46/EZ Europskog parlamenta i Vijeća utvrđuju se zahtjevi o dodacima prehrani.
The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
Uporabu dinatrijeve soli pirolokinolin kinona trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
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.
DONIJELA JE OVU UREDBU:
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
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.
Article 4
U razdoblju od pet godina od dana stupanja na snagu ove Uredbe odobrava se isključivo podnositelju zahtjeva: