natgillin/translations-raw huggingface dataset:
The person responsible for the placing on the market of a treated article treated with or incorporating penflufen shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Stavljanje tretiranih proizvoda na tržište podliježe sljedećem uvjetu:
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Osoba odgovorna za stavljanje na tržište tretiranog proizvoda koji je tretiran penflufenom ili koji ga sadržava mora osigurati da su na oznaci tog tretiranog proizvoda navedene informacije iz članka 58. stavka 3. drugog podstavka Uredbe (EU) br. 528/2012.
authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
o odobravanju promjene označivanja i posebnog zahtjeva za označivanje nove hrane sintetski zeaksantin u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.
Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
Natural zeaxanthin is a component of the normal human diet as it is found in many fruits and green vegetables as well as in egg yolk.
Komisija je na temelju članka 12.
It is also currently used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council.
Uredbe (EU) 2015/2283 dužna podnijeti nacrt provedbenog akta o stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
Commission Implementing Decision 2013/49/EU authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council, the placing on the market of synthetic zeaxanthin as a novel food ingredient in food supplements at the maximum intake of up to 2 mg per day.
Prirodni zeaksantin sastavni je dio uobičajene ljudske prehrane jer je prisutan u mnogim vrstama voća i zelenog povrća te u žumanjku jajeta.
The designation of synthetic zeaxanthin authorised by Implementing Decision 2013/49/EU on the labelling of the foodstuffs containing it is ‘synthetic zeaxanthin’.
Trenutačno se upotrebljava i u dodacima prehrani u smislu Direktive 2002/46/EZ Europskog parlamenta i Vijeća.
On 23 February 2018, the company DSM Nutritional Products Europe (‘the Applicant’) made a request to the Commission to authorise the amendment of the designation and of the specific labelling requirements for synthetic zeaxanthin within the meaning of Article 10(1) of Regulation (EU) 2015/2283.
Provedbenom odlukom Komisije 2013/49/EU odobreno je, u skladu s Uredbom (EZ) br. 258/97 Europskog parlamenta i Vijeća, stavljanje na tržište sintetskog zeaksantina kao novog sastojka hrane u dodacima prehrani pri najvećoj razini unosa do 2 mg dnevno.
The application requests the deletion of the term ‘synthetic’ from the designation of the novel food as listed in the Union list and from the labelling of foodstuffs containing it.
Pri označivanju hrane koja sadržava sintetski zeaksantin odobren Provedbenom odlukom 2013/49/EU navodi se „sintetski zeaksantin”.
The Applicant considers that the change of the designation and the labelling requirements of zeaxanthin is necessary to alleviate any potential negative economic impact that the use of the term ‘synthetic’ on the labelling of food supplements containing synthetic zeaxanthin may cause due to the negative connotation of the term ‘synthetic’.
Društvo DSM Nutritional Products Europe („podnositelj zahtjeva”) podnijelo je 23. veljače 2018. zahtjev Komisiji za odobrenje promjene označivanja i posebnih zahtjeva za označivanje sintetskog zeaksantina u smislu članka 10. stavka 1.
The Applicant also claims that such potential negative economic impact is most probably not experienced by economic operators placing on the market food supplements containing authorised synthetic novel foods which do not carry the term ‘synthetic’ on their labelling.
Uredbe (EU) 2015/2283.
There are a number of synthetic substances currently authorised and listed in the Union list of novel foods, of which the counterparts from natural origin exist, and both forms are used in food supplements.
U zahtjevu je zatraženo brisanje pojma „sintetski” iz označivanja te nove hrane kako je navedeno na popisu Unije te iz označivanja hrane koja sadržava taj pojam.
However those synthetic substances are not designated as synthetic in the Union list and are not labelled as such.
Podnositelj zahtjeva tvrdi da je promjena označivanja i zahtjeva za označivanje zeaksantina nužna kako bi se ublažio mogući negativan gospodarski učinak koji bi mogao nastati zbog uporabe pojma „sintetski” na oznakama dodataka prehrani koji sadržavaju sintetski zeaksantin, i to zbog negativne konotacije pojma „sintetski”.
The change in the designation and labelling of synthetic zeaxanthin will ensure consistency with the designation and labelling of those synthetic substances.
Podnositelj zahtjeva također tvrdi da gospodarski subjekti koji na tržište stavljaju dodatke prehrani koji sadržavaju odobrenu sintetsku novu hranu koja nije označena pojmom „sintetski”, najvjerojatnije nisu izloženi tom mogućem negativnom gospodarskom učinku.
There are no changes in the proposed uses and use levels of zeaxanthin when used as an ingredient in food supplements, the safety considerations that supported the authorisation of synthetic zeaxanthin by Implementing Decision 2013/49/EU remain valid and therefore this change does not pose any safety concerns.
Trenutačno se na Unijinu popisu odobrene nove hrane nalaze brojne sintetske tvari koje imaju ekvivalente prirodnog podrijetla, a oba se oblika upotrebljavaju kao dodaci prehrani.
Taking into account these legitimate factors, the proposed changes comply with Article 12(1) of Regulation (EU) 2015/2283.
Međutim, te sintetske tvari na Unijinu popisu nisu navedene kao sintetske tvari niti su tako označene.
The implementation of the new labelling requirement in accordance with this Implementing Regulation might involve changes for the business operators who currently place synthetic zeaxanthin on the market.
Promjenom označivanja sintetskog zeaksantina osigurat će se dosljednost u označivanju tih sintetskih tvari.
Therefore, it is appropriate to provide for a transitional period.
Nema promjena u predloženim uporabama i razinama uporabe zeaksantina ako se upotrebljava kao sastojak u dodacima prehrani i razmatranja u pogledu sigurnosti na kojima se temeljilo odobrenje sintetskog zeaksantina Provedbenom odlukom 2013/49/EU i dalje su valjana, stoga ta promjena ne izaziva zabrinutost u pogledu sigurnosti.
Directive 2002/46/EC lays down requirements on food supplements.
Uzimajući te legitimne čimbenike u obzir, predložene promjene u skladu su s člankom 12. stavkom 1.
The change of designation and of specific labelling requirement for zeaxanthin should be authorised without prejudice to that Directive.
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,
Provedba novog zahtjeva za označivanje u skladu s tom provedbenom uredbom mogla bi uključivati promjene za subjekte koji trenutačno stavljaju sintetski zeaksantin na tržište.
HAS ADOPTED THIS REGULATION:
Stoga je primjereno predvidjeti prijelazno razdoblje.
Article 1
Direktivom 2002/46/EZ utvrđuju se zahtjevi o dodacima prehrani.
The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance zeaxanthin shall be amended as specified in the Annex to this Regulation.
Promjenu označivanja i posebnog zahtjeva za označivanje zeaksantina trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The entry in the Union list referred to in the first paragraph shall include conditions of use and the labelling requirements laid down in the Annex to this Regulation.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
DONIJELA JE OVU UREDBU:
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Unos na Unijin popis odobrene nove hrane kako je predviđeno člankom 8.
Article 3
Uredbe (EU) 2015/2283 koji se odnosi na tvar zeaksantin mijenja se kako je navedeno u Prilogu ovoj Uredbi.
Food supplements containing synthetic zeaxanthin and complying with Regulation (EU) 2015/2283 as applicable before the entry into force of this Regulation may be placed on the market until 3 September 2019 and may remain on the market until exhaustion of stocks.
Unos na popis Unije iz prvog stavka uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
Article 4
Odobrenjem iz ovog članka ne dovode se u pitanje odredbe Direktive 2002/46/EZ.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se u skladu s Prilogom ovoj Uredbi.
Done at Brussels, 13 August 2018.
Članak 3.
For the Commission
Dodaci prehrani koji sadržavaju sintetski zeaksantin i koji su u skladu s Uredbom (EU) 2015/2283 kako se primjenjivala prije stupanja na snagu ove Uredbe mogu se stavljati na tržište do 3. rujna 2019. i mogu ostati na tržištu do iscrpljenja zaliha.
OJ L 327, 11.12.2015, p. 1.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
Sastavljeno u Bruxellesu 13. kolovoza 2018.
Commission Implementing Decision 2013/49/EU of 22 January 2013 authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 21, 24.1.2013, p. 32).
Za Komisiju
Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel food and novel food ingredients (OJ L 43, 14.2.1997, p. 1).
Predsjednik
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for ‘Zeaxanthin’ is replaced by the following:
Provedbena uredba Komisije (EU) 2017/2470 оd 20. prosinca 2017. o utvrđivanju Unijina popisa nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća o novoj hrani (SL L 351, 30.12.2017., str. 72.).
Authorised novel food
Direktiva 2002/46/EZ Europskog parlamenta i Vijeća od 10. lipnja 2002. o usklađivanju zakona država članica u odnosu na dodatke prehrani (SL L 183, 12.7.2002., str. 51.).
Conditions under which the novel food may be used
Provedbena odluka Komisije 2013/49/EU od 22. siječnja 2013. o odobravanju stavljanja na tržište sintetskog zeaksantina kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97 Europskog parlamenta i Vijeća (SL L 21, 24.1.2013., str. 32.).
Additional specific labelling requirements
Uredba (EZ) br. 258/97 Europskog parlamenta i Vijeća o novoj hrani i sastojcima nove hrane (SL L 43, 14.2.1997., str. 1.).
‘Zeaxanthin
PRILOG
Specified food category
U tablici 1.
Maximum levels
(Odobrena nova hrana) Priloga Provedbenoj uredbi (EU) 2017/2470 unos za „Zeaksantin” zamjenjuje se sljedećim:
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Zeaxanthin”.’
Odobrena nova hrana
Food Supplements as defined in Directive 2002/46/EC
Uvjeti pod kojima se nova hrana može upotrebljavati
2 mg/day
Dodatni posebni zahtjevi za označivanje proizvoda
authorising the placing on the market of dried aerial parts of Hoodia parviflora 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 osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.
Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
On 21 October 2014, the company Desert Labs, Ltd (‘the applicant’) made a request to the competent authority of Ireland to place dried aerial parts of Hoodia parviflora on the Union market as a novel food within the meaning of point (e) 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 dried aerial parts of Hoodia parviflora to be used in foods including beverages, biscuits, confectionary, savoury snacks, soups and broths, tea, coffee and water.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
It is also intended for use in food supplements.
Društvo Desert Labs, Ltd. („podnositelj zahtjeva”) podnijelo je 21. listopada 2014. nadležnom tijelu Irske zahtjev za stavljanje na tržište Unije osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane u smislu članka 1. stavka 2. točke (e) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
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 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.
Zahtjevom se tražilo odobrenje uporabe osušenih nadzemnih dijelova biljke Hoodia parviflora u hrani uključujući pića, kekse, slatkiše, pikantne grickalice, juhe i mesne juhe, čaj, kavu i vodu.
While the request for placing dried aerial parts of Hoodia parviflora 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.
Namijenjeni su i za uporabu u dodacima prehrani.
On 24 August 2015, 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 dried aerial parts of Hoodia parviflora meets the criteria for novel food set out in Article 3(1) 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 28 August 2015, the Commission forwarded the initial assessment report to the other Member States.
Uredbe (EZ) br. 258/97 i za koje nije donesena konačna odluka prije 1. siječnja 2018. tretiraju se kao zahtjevi podneseni u skladu s Uredbom (EU) 2015/2283.
Reasoned objections were raised by some Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to insufficient characterisation of the novel food, limited assessment of allergenicity, insufficient data to exclude the risk for children older than 12 years, insufficient information on the specifications, stability, intake assessment and on toxicological data.
Zahtjev za stavljanje na tržište Unije osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane podnesen je državi članici u skladu s člankom 4.
In view of the objections raised by some Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 25 January 2016, asking it to carry out an additional assessment for dried aerial parts of Hoodia parviflora as novel food in accordance with Regulation (EC) No 258/97.
Uredbe (EZ) br. 258/97, a ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
On 20 September 2017, the Authority adopted ‘Scientific Opinion on the safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97’.
Nadležno tijelo Irske izdalo je 24. kolovoza 2015. izvješće o početnoj procjeni.
That 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 osušeni nadzemni dijelovi biljke Hoodia parviflora ispunjuju kriterije za novu hranu utvrđene člankom 3. stavkom 1.
In its opinion, the Authority did not establish the safety of dried aerial parts of Hoodia parviflora in foods at the uses and use levels proposed by the applicant because the intake would exceed the level which is considered as safe (0,134 mg/kg bw).
Uredbe (EZ) br. 258/97.
However, the Authority concluded that dried aerial parts of Hoodia parviflora are safe for adults when added to food supplements at a maximum daily dose of 9,4 mg which corresponds to the safe level of intake for an adult with a default body weight of 70 kg.
Komisija je 28. kolovoza 2015. izvješće o početnoj procjeni proslijedila ostalim državama članicama.
That opinion gives sufficient grounds to establish that dried aerial parts of Hoodia parviflora in the proposed uses and use levels when used as an ingredient in food supplements, comply with Article 12(1) of Regulation (EU) 2015/2283.
Neke države članice uložile su obrazložene prigovore u roku od 60 dana propisanom člankom 6. stavkom 4. prvim podstavkom Uredbe (EZ) br. 258/97 s obzirom na nedostatan opis svojstava nove hrane, ograničenu procjenu alergenosti, nedostatne podatke za isključivanje rizika za djecu stariju od 12 godina, nedostatne podatke o specifikacijama, stabilnost, procjenu unosa te toksikološke podatke.
On 24 January 2018, the applicant made a request to the Commission for protection of proprietary data for two studies submitted in support of the application namely, reports of the 14-day dose-finding oral toxicity study of dried aerial parts of Hoodia parviflora, and of the 90-day oral toxicity study, served as basis for the Bench Mark Dose (BMD) analysis and for deriving safe intake levels for human.
S obzirom na prigovore koje su uložile neke države članice, Komisija se 25. siječnja 2016. obratila Europskoj agenciji za sigurnost hrane („Agencija”) te od nje zatražila da provede dodatnu procjenu osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane u skladu s Uredbom (EZ) br. 258/97.
On 18 February 2018, the Authority considered that in elaborating its opinion on dried aerial parts of Hoodia parviflora as a novel food the data from the report of the 90-day oral toxicity study served as basis for the BMD analysis and for deriving safe intake levels for humans.
EFSA je 20. rujna 2017. donijela „Znanstveno mišljenje o sigurnosti osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane u skladu s Uredbom (EZ) br. 258/97”.
Therefore, it is considered that the conclusions on the safety of dried aerial parts of Hoodia parviflora, could not have been reached without the data from the report of that study.
Iako je Agencija to mišljenje izradila i donijela na temelju Uredbe (EZ) br. 258/97, ono je u skladu sa zahtjevima iz članka 11.
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, and their claim to an exclusive right of reference to that study, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283.
The applicant has also declared that, at the time the application was submitted, it held proprietary and exclusive rights of reference to the study under national law and that therefore third parties could not lawfully access or use that study.
Agencija u mišljenju nije utvrdila sigurnost osušenih nadzemnih dijelova biljke Hoodia parviflora u hrani pri uporabi i razinama uporabe koje je predložio podnositelj zahtjeva jer bi se tim unosom premašila razina koja se smatra sigurnom (0,134 mg/kg tjelesne mase).
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.
No, Agencija je ipak zaključila da su osušeni nadzemni dijelovi biljke Hoodia parviflora sigurni za odrasle osobe ako se dodaju dodacima prehrani u najvećoj dnevnoj dozi od 9,4 mg koja odgovara sigurnoj razini unosa kod odrasle osobe zadane tjelesne mase od 70 kg.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the 90-day oral toxicity study contained in the applicant's file should not be used by EFSA 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 su osušeni nadzemni dijelovi biljke Hoodia parviflora u okviru predloženih uporaba i razina uporabe, ako se upotrebljavaju kao sastojak u dodacima prehrani, u skladu s kriterijima utvrđenima 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 study 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.
Podnositelj zahtjeva Komisiji je 24. siječnja 2018. podnio zahtjev za zaštitu vlasničkih podataka povezanih s dvjema studijama provedenima u potporu zahtjevu, i to za izvješće o 14-dnevnoj studiji oralne toksičnosti za utvrđivanje doza osušenih nadzemnih dijelova biljke Hoodia parviflora te izvješće o 90-dnevnoj studiji oralne toksičnosti, koje je služilo kao osnova za analizu referentne doze (BMD) i za određivanje sigurnih razina unosa za ljude.
Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements.
Agencija je 18. veljače 2018. navela da su u obrazloženju njezina mišljenja o osušenim nadzemnim dijelovima biljke Hoodia parviflora kao nove hrane podaci iz izvješća o 90-dnevnoj studiji oralne toksičnosti služili kao osnova za analizu BMD-a i za određivanje sigurnih razina unosa za ljude.
The use of dried aerial parts of Hoodia parviflora should be authorised without prejudice to that Directive.
Stoga se smatra da zaključci o sigurnosti osušenih nadzemnih dijelova biljke Hoodia parviflora nisu mogli biti doneseni bez podataka iz izvješća o toj studiji.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Nakon primitka mišljenja Agencije Komisija je zatražila od podnositelja zahtjeva da dodatno pojasni podneseno obrazloženje u pogledu njegova zahtjeva za zaštitu vlasničkih podataka iz studije i zahtjeva za isključivo pravo upućivanja na tu studiju, kako je navedeno u članku 26. stavku 2. točkama (a) i (b) Uredbe (EU) 2015/2283.