natgillin/translations-raw huggingface dataset:
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.
Društvo Biova, LLC („podnositelj zahtjeva”) podnijelo je 5. kolovoza 2016. nadležnom tijelu Danske zahtjev za stavljanje na tržište Unije hidrolizata jajne ovojnice kao novog sastojka hrane u smislu članka 1. stavka 2. točke (e) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
While the request for placing egg membrane hydrolysate 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.
U zahtjevu se traži da se odobri upotreba hidrolizata jajne ovojnice u dodacima prehrani za opću odraslu populaciju.
On 7 June 2017, the competent authority of Denmark issued its initial assessment report.
U skladu s člankom 35. stavkom 1.
In that report, it concluded that egg membrane hydrolysate meets the criteria for a novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.
Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište u Uniji koji su podneseni državi članici u skladu s člankom 4.
On 12 June 2017, 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 u skladu s Uredbom (EU) 2015/2283.
Reasoned objections were raised by other 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 the manufacturing process, composition, toxicological data and potential drug interaction between the novel food and medication taken by people with joint pain.
Zahtjev za stavljanje na tržište u Uniji hidrolizata jajne ovojnice kao nove hrane podnesen je državi članici u skladu s člankom 4.
In a subsequent application submitted on 5 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 detailed manufacturing process description, the Generally Recognized as Safe (GRAS) Status of BiovaFlex.
Uredbe (EZ) br. 258/97 te ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
Expert Panel Report, an analysis of solubilized egg shell membrane using Radioallergosorbent Test Inhibition, quantitative egg allergen test results, an in vitro mammalian cell micronucleus assay in TK6 cells, an acute oral toxicity study, a bacterial reverse mutation assayST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); January 2009a (unpublished).
Nadležno tijelo Danske izdalo je 7. lipnja 2017. izvješće o početnoj ocjeni.
, a human clinical safety and efficacy pilot, guinea pig sensitization (Buehler) study, and a haematology and blood biochemistry data and study report.
U tom je izvješću zaključilo da hidrolizat jajne ovojnice ispunjava kriterije za novi sastojak hrane utvrđene u članku 3. stavku 1.
The Commission consulted the European Food Safety Authority (‘the Authority’) on 20 April 2018, asking it to carry out an additional assessment for egg membrane hydrolysate as a novel food in accordance with Regulation (EU) 2015/2283.
Uredbe (EZ) br. 258/97.
On 27 June 2018, the Authority adopted ‘Scientific Opinion on the safety of egg membrane hydrolysate as a novel food pursuant to Regulation (EU) 2015/2283’.
Komisija je 12. lipnja 2017. izvješće o početnoj ocjeni proslijedila ostalim državama članicama.
This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Ostale države članice uložile su obrazložene prigovore u roku od 60 dana propisanom u članku 6. stavku 4. prvom podstavku Uredbe (EZ) br. 258/97 u pogledu proizvodnog postupka, sastava, toksikoloških podataka i mogućih interakcija nove hrane s lijekovima koje uzimaju osobe koje pate od boli u zglobovima.
That opinion gives sufficient grounds to establish that egg membrane hydrolysate, 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 naknadnom zahtjevu podnesenom 5. siječnja 2018. podnositelj zahtjeva zatražio je od Komisije zaštitu vlasnički zaštićenih podataka za niz studija koje je dostavio u potporu zahtjevu, i to detaljan opis proizvodnog postupka, izvješće stručne skupine o GRAS statusu za BiovaFlex, analizu otopljene ovojnice ljuske jajeta s pomoću radioalergosorbent-testa inhibicije, rezultate kvantitativnog testa alergena jaja, in vitro mikronukleus-test na TK6 stanicama sisavaca, studiju akutne oralne toksičnosti, bakterijski test povratnih mutacijaST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); siječanj 2009.a (neobjavljeno).
In its opinion on egg membrane hydrolysate as a novel food, the Authority considered that the data on the manufacturing process served as a basis to assess the safety of egg membrane hydrolysate.
, kliničku pilot-studiju o sigurnosti i djelotvornosti za ljude, studiju senzibilizacije na zamorcima (Buehler) te podatke o hematološkim i biokemijskim pretragama krvi i izvješće o studiji.
Therefore, the Authority considers that the conclusions on the safety of egg membrane hydrolysate, could not have been arrived at without the data from the unpublished report of this process.
Komisija je 20. travnja 2018. zatražila od Europske agencije za sigurnost hrane („Agencija”) da provede dodatnu ocjenu hidrolizata jajne ovojnice kao nove hrane u skladu s Uredbom (EU) 2015/2283.
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 studies and to clarify their claim to an exclusive right of reference to those studies, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
Agencija je 27. lipnja 2018. donijela „Znanstveno mišljenje o sigurnosti hidrolizata jajne ovojnice kao nove hrane u skladu s Uredbom (EU) 2015/2283”.
The Applicant also declared to hold proprietary and exclusive rights to the studies under national law at the time the application was submitted, and that therefore third parties could not lawfully access or use those studies.
To je mišljenje u skladu sa zahtjevima članka 11.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the detailed manufacturing process description contained in the Applicant's file and without which the novel food could not have been assessed by the Authority 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 hidrolizat jajne ovojnice u skladu s člankom 12. stavkom 1.
However, restricting the authorisation of this novel food and of the reference to the detailed manufacturing process description 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.
U svojem mišljenju o hidrolizatu jajne ovojnice kao novoj hrani Agencija smatra da su podaci o proizvodnom postupku upotrijebljeni kao osnova za ocjenu sigurnosti hidrolizata jajne ovojnice.
As the source of the novel food comes from eggs, which is listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council as one of a number of substances or products which cause allergies or intolerances, food supplements containing egg membrane hydrolysate should be appropriately labelled following the requirements of Article 21 of that Regulation.
Stoga smatra da zaključci o sigurnosti hidrolizata jajne ovojnice ne bi mogli biti doneseni bez podataka iz neobjavljenog izvješća o tom postupku.
Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements.
Nakon primitka mišljenja Agencije Komisija je zatražila od podnositelja zahtjeva da dodatno pojasni dano obrazloženje u pogledu njegova zahtjeva za zaštitu vlasnički zaštićenih podataka iz studija 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 use of egg membrane hydrolysate should be authorised without prejudice to that Directive.
Podnositelj zahtjeva izjavio je i da je u trenutku podnošenja zahtjeva bio nositelj vlasničkih i isključivih prava na studije u skladu s nacionalnim pravom te da stoga treće osobe nisu mogle imati zakonit pristup tim studijama niti se koristiti njima.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Komisija je ocijenila sve informacije koje je dostavio podnositelj zahtjeva te zaključila da je podnositelj zahtjeva dostatno potkrijepio ispunjenje zahtjeva utvrđenih u članku 26. stavku 2.
Article 1
U skladu s tim, kako je predviđeno u članku 26. stavku 2.
Egg membrane hydrolysate 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.
Uredbe (EU) 2015/2283, Agencija detaljan opis proizvodnog postupka, koji je sadržan u dokumentaciji podnositelja zahtjeva i bez kojeg Agencija ne bi mogla ocijeniti novu hranu, ne bi smjela upotrijebiti u korist budućeg podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
Slijedom toga, stavljanje na tržište u Uniji nove hrane odobrene ovom Uredbom trebalo bi ograničiti na podnositelja zahtjeva tijekom razdoblja od pet godina.
Company: Biova, LLC
Međutim, ograničenje upotrebe odobrenja te nove hrane i upućivanja na detaljan opis proizvodnog postupka, koji je sadržan u dokumentaciji podnositelja zahtjeva, isključivo na podnositelja zahtjeva ne sprečava druge podnositelje zahtjeva da podnesu zahtjev za odobrenje stavljanja na tržište iste nove hrane pod uvjetom da se njihov zahtjev temelji na zakonito pribavljenim informacijama koje podupiru odobrenje u skladu s ovom Uredbom.
Address: 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA
Budući da se nova hrana dobiva od jaja, koja su u Prilogu II.
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 Biova, LLC.
Uredbi (EU) br. 1169/2011 Europskog parlamenta i Vijeća navedena među tvarima ili proizvodima koji uzrokuju alergije ili netolerancije, dodatke prehrani koji sadržavaju hidrolizat jajne ovojnice trebalo bi na odgovarajući način označiti u skladu sa zahtjevima članka 21. te uredbe.
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 utvrđeni su zahtjevi o dodacima prehrani.
The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
Upotrebu hidrolizata jajne ovojnice trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The study 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 fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, 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 Biova, LLC.
DONIJELA JE OVU UREDBU:
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Hidrolizat jajne ovojnice, kako je naveden u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen u Provedbenoj uredbi (EU) 2017/2470.
Article 4
Tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe isključivo je prvotnom podnositelju zahtjeva,
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
društvu: Biova, LLC
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Adresa: 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa SAD
Done at Brussels, 31 October 2018.
odobreno stavljati na tržište u Uniji novu hranu iz stavka 1., osim ako budući podnositelj zahtjeva dobije odobrenje za tu novu hranu bez upućivanja na podatke zaštićene u skladu s člankom 2. ove Uredbe ili uz suglasnost društva Biova, LLC.
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).
Studija iz dokumentacije podnositelja zahtjeva na temelju koje je Agencija ocijenila novu hranu iz članka 1., i za koju podnositelj zahtjeva tvrdi da ispunjava zahtjeve utvrđene u članku 26. stavku 2.
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).
Uredbe (EU) 2015/2283, ne smije se upotrebljavati u korist budućih podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe bez suglasnosti društva Biova, LLC.
Biova, LLC; February 2015 (unpublished).
Članak 3.
Food Allergy Research and Resource Program, University of Nebraska, Lincoln; April 2014 (unpublished).
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se u skladu s Prilogom ovoj Uredbi.
Food Allergy Research and Resource Program, University of Nebraska, Lincoln; February 2008b (unpublished).
Članak 4.
BioReliance Corporation, Rockville (MD) for NIS Labs, Klamath Falls (OR); January 2016 (unpublished).
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
ST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); January 2009a (unpublished).
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
ST&T Consultants, San Francisco (CA) for Biova LLC; July 2009c (unpublished).
Sastavljeno u Bruxellesu 31. listopada 2018.
ST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); February 2009a (unpublished).
Za Komisiju
ST&T Consultants, San Francisco (CA); July 2009c (unpublished).
Predsjednik
EFSA Journal 2018; 16(7):5363
SL L 327, 11.12.2015., str. 1.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).
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.).
ANNEX
Biova, LLC; veljača 2015. (neobjavljeno).
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
Food Allergy Research and Resource Program, University of Nebraska, Lincoln; travanj 2014. (neobjavljeno).
the following last column is added in Table 1 (Authorised novel foods):
Food Allergy Research and Resource Program, University of Nebraska, Lincoln; veljača 2008.b (neobjavljeno).
‘Data Protection’
BioReliance Corporation, Rockville (MD) for NIS Labs, Klamath Falls (OR); siječanj 2016. (neobjavljeno).
the following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
ST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); siječanj 2009.a (neobjavljeno).
Authorised novel food
ST&T Consultants, San Francisco (CA) for Biova LLC; srpanj 2009.c (neobjavljeno).
Conditions under which the novel food may be used
ST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); veljača 2009.a (neobjavljeno).
Additional specific labelling requirements
ST&T Consultants, San Francisco (CA); srpanj 2009.c (neobjavljeno).
Other requirements
EFSA Journal 2018.; 16(7):5363.
Data Protection
Uredba (EU) br. 1169/2011 Europskog parlamenta i Vijeća od 25. listopada 2011. o informiranju potrošača o hrani, izmjeni uredbi (EZ) br. 1924/2006 i (EZ) br. 1925/2006 Europskog parlamenta i Vijeća te o stavljanju izvan snage Direktive Komisije 87/250/EEZ, Direktive Vijeća 90/496/EEZ, Direktive Komisije 1999/10/EZ, Direktive 2000/13/EZ Europskog parlamenta i Vijeća, direktiva Komisije 2002/67/EZ i 2008/5/EZ i Uredbe Komisije (EZ) br. 608/2004 (SL L 304, 22.11.2011., str. 18.).
‘Egg membrane hydrolysate
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.).
Authorised on 25 November 2018.
(Odobrena nova hrana):
Applicant: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA
Sljedeći unos umeće se abecednim redom u tablicu 1.
During the period of data protection the novel food egg membrane hydrolysate is authorised for placing on the market within the Union only by Biova, LLC. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Biova, LLC.
(Odobrena nova hrana):
End date of the data protection: 25 November 2023’.
Odobrena nova hrana
Food Supplements as defined in Directive 2002/46/EC intended for the general adult population
Uvjeti pod kojima se nova hrana može upotrebljavati
450 mg/day
Dodatni posebni zahtjevi za označivanje proizvoda
Specification
„Hidrolizat jajne ovojnice
Description
Određena kategorija hrane
The egg membrane hydrolysate is derived from the eggshell membranes of chicken eggs.
Najveće dopuštene količine
The eggshells undergo hydro-mechanical separation in order to obtain the egg membranes, which are then further processed using a patented solubilisation method.
Pri označivanju hrane koja sadržava novu hranu navodi se „hidrolizat jajne ovojnice”.
Following the solubilisation process, the solution is filtered, concentrated, spray-dried and packaged.
Podnositelj zahtjeva: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa SAD
Characteristics/Composition
Tijekom razdoblja zaštite podataka stavljanje na tržište u Uniji nove hrane hidrolizat jajne ovojnice odobreno je isključivo podnositelju zahtjeva Biova, LLC., osim ako budući podnositelj zahtjeva dobije odobrenje za novu hranu bez upućivanja na vlasnički zaštićene znanstvene dokaze ili znanstvene podatke zaštićene u skladu s člankom 26.
Chemical parameters
Uredbe (EU) 2015/2283 ili uz suglasnost društva Biova, LLC.
Methods
Datum prestanka zaštite podataka: 25. studenoga 2023.”
Total nitrogen-containing compounds (% w/w): ≥ 88
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni općoj odrasloj populaciji
Collagen (% w/w): ≥ 15
Sljedeći unos umeće se abecednim redom u tablicu 2.
Elastin (% w/w): ≥ 20
Odobrena nova hrana
FastinTM Elastin Assay
Specifikacija
Total glycosaminoglycans (% w/w): ≥ 5
Opis
USP26 (chondroitin sulphate K0032 method)
Hidrolizat jajne ovojnice dobiva se od ovojnice ljuske kokošjih jaja.
Calcium: ≤ 1 %
Ljuske jajeta podvrgnu se hidromehaničkoj separaciji kako bi se dobile jajne ovojnice, koje se zatim dalje prerađuju putem patentirane metode otapanja.
Physical parameters
Nakon postupka otapanja otopina se filtrira, koncentrira, suši raspršivanjem i pakira.
pH: 6,5 – 7,6
Svojstva/sastav
Ash (% w/w): ≤ 8
Kemijski parametri
Moisture (% w/w): ≤ 9
Metode
Water activity: ≤ 0,3
Ukupno spojevi koji sadržavaju dušik (% m/m): ≥ 88
Solubility (in water): soluble
Izgaranje prema AOAC 990.03 i AOAC 992.15
Bulk density: ≥ 0,6 g/cc
Kolagen (% m/m): ≥ 15
Heavy metals
Elastin (% m/m): ≥ 20
Arsenic ≤ 0,5 mg/kg
Ukupni glikozaminoglikani (% m/m): ≥ 5
Microbiological criteria
USP26 (metoda K0032 s kondroitin sulfatom)
Aerobic plate count: ≤ 2500 CFU/g
Kalcij: ≤ 1 %
Salmonella: Negative (in 25 g)
Fizikalni parametri
Coliforms: ≤ 10 MPN/g
pH: 6,5–7,6
Mesophilic spore count: ≤ 25 CFU/g
Pepeo (% m/m): ≤ 8
Thermophilic spore count: ≤ 10 CFU/10 g
Vlaga (% m/m): ≤ 9
Yeast: ≤ 10 CFU/g
Aktivnost vode: ≤ 0,3
In a subsequent application submitted on 5 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 detailed manufacturing process description, the Generally Recognized as Safe (GRAS) Status of BiovaFlex.
Teški metali
Expert Panel Report, an analysis of solubilized egg shell membrane using Radioallergosorbent Test Inhibition, quantitative egg allergen test results, an in vitro mammalian cell micronucleus assay in TK6 cells, an acute oral toxicity study, a bacterial reverse mutation assayST&T Consultants, San Francisco (CA) for Biova LLC, Johnston (IA); January 2009a (unpublished).
Arsen ≤ 0,5 mg/kg
authorising the placing on the market of xylo-oligosaccharides 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 ksilo-oligosaharida kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
On 4 May 2016, the company Longlive Europe Food Division Ltd (‘the Applicant’) submitted a request to the competent authority of Hungary to place xylo-oligosaccharides on the Union market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council.
U skladu s člankom 12.
The application requests for xylo-oligosaccharides to be used in a number of food categories, namely, bakery and dairy products, fruit spreads, chocolate confectionery and soy-drinks for the general population.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije te 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, 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 Longlive Europe Food Division Ltd. („podnositelj zahtjeva”) podnijelo je 4. svibnja 2016. nadležnom tijelu Mađarske zahtjev za stavljanje na tržište Unije ksilo-oligosaharida kao novog sastojka hrane u smislu članka 1. stavka 2. točke (e) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
While the request for placing xylo-oligosaccharides 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.
U zahtjevu se traži da se odobri upotreba ksilo-oligosaharida u više kategorija hrane, i to u pekarskim i mliječnim proizvodima, voćnim namazima, čokoladnim slasticama i napicima od soje za opću populaciju.