natgillin/translations-raw huggingface dataset:
Therefore, it is considered that the conclusions on the safety of bovine milk basic whey protein isolate could not have been reached without the data from the report of this study.
S obzirom na prigovore koje su uložile ostale države članice Komisija je 11. prosinca 2017. zatražila od Europske agencije za sigurnost hrane („Agencija”) da provede dodatnu procjenu bazičnog izolata bjelančevine sirutke iz mlijeka goveda kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97.
Following 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 90-day oral toxicity in rats study report, and to clarify their claim to an exclusive right of reference to this study, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
U naknadnom zahtjevu podnesenom 3. siječnja 2018. podnositelj zahtjeva zatražio je od Komisije zaštitu vlasničkih podataka iz niza studija dostavljenih u potporu zahtjevu, i to dvije kliničke studije na ljudima provedene upotrebom bazičnog izolata bjelančevine sirutke iz mlijeka goveda, in vitro bakterijskog testa povratnih mutacija, in vitro mikronukleus testa na stanicama sisavaca, 90-dnevne studije oralne toksičnosti u štakora, šestotjedne studije razvojne toksičnosti u mladih štakora i elektroforezom bazičnog izolata bjelančevine sirutke iz mlijeka goveda.
The Applicant also declared to hold proprietary and exclusive rights of reference to the study under national law at the time the application was submitted, and that therefore third parties could not lawfully access or use this study.
Agencija je 27. lipnja 2018. donijela „Znanstveno mišljenje o sigurnosti bazičnog izolata bjelančevine sirutke iz mlijeka goveda kao nove hrane u skladu s Uredbom (EU) 2015/2283”.
The Commission has assessed all the information provided by the Applicant and considers that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.
To je mišljenje u skladu sa zahtjevima iz članka 11.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the 90-day oral toxicity study in rats 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.
Uredbe (EU) 2015/2283.
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.
U tom se mišljenju iznosi dovoljno informacija na temelju kojih se može utvrditi da je bazični izolat bjelančevine sirutke iz mlijeka goveda u predloženim uporabama i razinama uporabe, kada se upotrebljava kao sastojak u početnoj i prijelaznoj hrani za dojenčad, zamjeni za cjelodnevnu prehranu pri redukcijskoj dijeti, hrani za posebne medicinske potrebe i dodacima prehrani, u skladu s člankom 12. stavkom 1.
However, restricting the authorisation of this novel food and of the reference to the 90-day oral toxicity study in rats 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.
Uredbe (EU) 2015/2283.
As the source of the novel food comes from milk, 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, foods and food supplements containing bovine milk basic whey protein isolate should be appropriately labelled following the requirements of Article 21 of that Regulation.
Agencija je u svojem mišljenju o bazičnom izolatu bjelančevine sirutke iz mlijeka goveda navela da su podaci iz 90-dnevne studije oralne toksičnosti u štakora služili kao osnova za utvrđivanje referentne točke i ocjenu dostatne granice izloženosti u odnosu na predloženu najveću razinu unosa nove hrane kod ljudi.
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 bazičnog izolata bjelančevine sirutke iz mlijeka goveda ne bi mogli biti doneseni bez podataka iz izvješća o toj studiji.
The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Directive.
Nakon primitka mišljenja Agencije Komisija je zatražila od podnositelja zahtjeva da dodatno pojasni podneseno obrazloženje svojeg zahtjeva za zaštitu vlasničkih podataka iz izvješća o 90-dnevnoj studiji oralne toksičnosti u štakora 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.
Regulation (EU) No 609/2013 of the European Parliament and of the Council lays down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.
Podnositelj zahtjeva tvrdio je i da je u vrijeme podnošenja zahtjeva bio nositelj vlasničkih i isključivih prava upućivanja na studiju u skladu s nacionalnim pravom te da stoga treća strana nije mogla imati zakonit pristup toj studiji niti se koristiti njome.
The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Regulation.
Komisija je ocijenila sve podatke koje je dostavio podnositelj zahtjeva i smatra da je podnositelj zahtjeva dostatno obrazložio ispunjenje zahtjeva utvrđenih u članku 26. stavku 2.
HAS ADOPTED THIS REGULATION:
U skladu s tim, kako je predviđeno člankom 26. stavkom 2.
Article 1
Uredbe (EU) 2015/2283, Agencija ne smije upotrijebiti 90-dnevnu studiju oralne toksičnosti u štakora, koja je dio dosjea podnositelja zahtjeva i bez koje Agencija ne može ocijeniti novu hranu, u korist budućeg podnositelja zahtjeva tijekom razdoblja od pet godina od dana stupanja na snagu ove Uredbe.
Bovine milk basic whey protein isolate 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.
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.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
Međutim, ograničenje odobrenja te nove hrane i upućivanje na 90-dnevnu studiju oralne toksičnosti u štakora 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 podacima kojima se podupire odobrenje u skladu s ovom Uredbom.
Company: Armor Protéines S.A.S.
Budući da je nova hrana proizvedena iz mlijeka, koje je u Prilogu II.
Address: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France
Uredbi (EU) br. 1169/2011 Europskog parlamenta i Vijeća navedeno među brojnim tvarima ili proizvodima koji uzrokuju alergije ili netolerancije, hrana i dodaci prehrani koji sadržavaju bazični izolat bjelančevine sirutke iz mlijeka goveda trebali bi biti na odgovarajući način označeni u skladu sa zahtjevima iz članka 21. te uredbe.
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 Armor Protéines S.A.S.
Direktivom 2002/46/EZ Europskog parlamenta i Vijeća utvrđuju se zahtjevi o dodacima prehrani.
The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
Uporabu bazičnog izolata bjelančevine sirutke iz mlijeka goveda trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 1169/2011, to the provisions of Directive 2002/46/EC, and to the provisions of Regulation (EU) No 609/2013.
Uredbom (EU) br. 609/2013 Europskog parlamenta i Vijeća utvrđeni su zahtjevi za hranu za dojenčad i malu djecu, hranu za posebne medicinske potrebe i zamjenu za cjelodnevnu prehranu pri redukcijskoj dijeti.
Article 2
Uporabu bazičnog izolata bjelančevine sirutke iz mlijeka goveda trebalo bi odobriti ne dovodeći u pitanje tu uredbu.
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 Armor Protéines S.A.S.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Article 4
Bazični izolat bjelančevine sirutke iz mlijeka goveda, kako je navedeno u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen Provedbenom uredbom (EU) 2017/2470.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
U razdoblju od pet godina od dana stupanja na snagu ove Uredbe odobrava se isključivo prvotnom podnositelju zahtjeva:
This Regulation shall be binding in its entirety and directly applicable in all Member States.
društvu: Armor Protéines S.A.S.,
Done at Brussels, 30 October 2018.
s adresom: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, Francuska
For the Commission
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 Armor Protéines S.A.S.
The President
Unos na popis Unije iz stavka 1. uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
OJ L 327, 11.12.2015, p. 1.
Odobrenjem iz ovog članka ne dovode se u pitanje odredbe Uredbe (EU) br. 1169/2011, odredbe Direktive 2002/46/EZ i odredbe Uredbe (EU) br.
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).
609/2013.
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).
Članak 2.
EFSA Journal 2018; 16(7):5360.
Studija iz dosjea podnositelja zahtjeva na temelju koje je Agencija provela ocjenu nove hrane iz članka 1., za koju podnositelj zahtjeva tvrdi da ispunjava zahtjeve utvrđene u članku 26. stavku 2.
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).
Uredbe (EU) 2015/2283, ne smije se upotrijebiti u korist budućih podnositelja zahtjeva u razdoblju od pet godina od dana stupanja na snagu ove Uredbe bez suglasnosti društva Armor Protéines S.A.S.
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).
Članak 3.
Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009, (OJ L 181, 29.6.2013, p. 35).
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se u skladu s Prilogom ovoj Uredbi.
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
the following last column is added in Table 1 (Authorised novel foods):
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
‘Data Protection’
Sastavljeno u Bruxellesu 30. listopada 2018.
the following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
Za Komisiju
Data Protection
EFSA Journal 2018.; 16(7):5360.
‘Bovine milk basic whey protein isolate
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.).
Maximum levels
Uredba (EU) br. 609/2013 Europskog parlamenta i Vijeća od 12. lipnja 2013. o hrani za dojenčad i malu djecu, hrani za posebne medicinske potrebe i zamjeni za cjelodnevnu prehranu pri redukcijskoj dijeti te o stavljanju izvan snage Direktive Vijeća 92/52/EEZ, direktiva Komisije 96/8/EZ, 1999/21/EZ, 2006/125/EZ i 2006/141/EZ, Direktive 2009/39/EZ Europskog parlamenta i Vijeća i uredbi Komisije (EZ) br. 41/2009 i (EZ) br. 953/2009 (SL L 181, 29.6.2013., str. 35.).
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”.
PRILOG
Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se kako slijedi:
“This food supplement should not be consumed by children/adolescents under the age of three/eighteen (*) years”
Sljedeći zadnji stupac umeće se u tablicu 1.
Depending on the age group the food supplement is intended for.
(Odobrena nova hrana):
Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France
(Odobrena nova hrana):
During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S..
Odobrena nova hrana
End date of the data protection: 20 November 2023.’
Uvjeti pod kojima se nova hrana može upotrebljavati
Infant formulae as defined in Regulation (EU) No 609/2013
Dodatni posebni zahtjevi za označivanje proizvoda
30 mg/100 g (powder)
Ostali zahtjevi
3,9 mg/100 mL (reconstituted)
Zaštita podataka
Follow-on formulae as defined in Regulation (EU) No 609/2013
„Bazični izolat bjelančevine sirutke iz mlijeka goveda
4,2 mg/100 mL (reconstituted)
Određena kategorija hrane
Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013
Najveće dopuštene količine
300 mg/day
Pri označivanju hrane koja sadržava novu hranu navodi se ‚Izolat bjelančevine sirutke iz mlijeka’.
Foods for special medical purposes as defined in Regulation (EU) No 609/2013
Dodaci prehrani koji sadržavaju bazični izolat bjelančevine sirutke iz mlijeka goveda nose sljedeću izjavu:
58 mg/day for young children
‚Ovaj dodatak prehrani ne smiju konzumirati djeca/adolescenti mlađi od tri/osamnaest (*) godina.’
380 mg/day for children and adolescents from 3 to 18 years of age
Ovisno o dobnoj skupini kojoj je dodatak prehrani namijenjen.
610 mg/day for adults
Podnositelj zahtjeva: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, Francuska
Food Supplements as defined in Directive 2002/46/EC
Tijekom razdoblja zaštite podataka stavljanje na tržište Unije nove hrane bazični izolat bjelančevine sirutke iz mlijeka goveda odobrava se isključivo društvu Armor Protéines S.A.S., 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.
250 mg/day for children and adolescents from 3 to 18 years of age
Uredbe (EU) 2015/2283 ili uz suglasnost društva Armor Protéines S.A.S.
the following entry is inserted in Table 2 (Specifications) in alphabetical order:
Datum završetka zaštite podataka: 20. studenoga 2023.”
Authorised Novel Food
Početna hrana za dojenčad u smislu Uredbe (EU) br. 609/2013
Specification
30 mg/100 g (prah)
Description
3,9 mg/100 ml (rekonstituirana hrana)
Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.
Prijelazna hrana za dojenčad u smislu Uredbe (EU) br. 609/2013
Characteristics/Composition
4,2 mg/100 ml (rekonstituirana hrana)
Total protein (w/weight of product): ≥ 90 %
Zamjena za cjelodnevnu prehranu pri redukcijskoj dijeti kako je definirana Uredbom (EU) br. 609/2013
Lactoferrin (w/weight of product): 25-75 %
300 mg dnevno
Lactoperoxidase (w/weight of product): 10-40 %
Hrana za posebne medicinske potrebe u smislu Uredbe (EU) br. 609/2013
Other proteins (w/weight of product): ≤ 30 %
58 mg dnevno za malu djecu
TGF-β2: 12-18 mg/100 g
380 mg dnevno za djecu i adolescente u dobi od 3 do 18 godina
Moisture: ≤ 6,0 %
610 mg dnevno za odrasle
pH (5 % solution w/v): 5,5 – 7,6
Dodaci prehrani u smislu Direktive 2002/46/EZ
Lactose: ≤ 3,0 %
250 mg dnevno za djecu i adolescente u dobi od 3 do 18 godina
Fat: ≤ 4,5 %
Sljedeći unos umeće se abecednim redom u tablicu 2.
Ash: ≤ 3,5 %
(Specifikacije):
Iron: ≤ 25 mg/100 g
Odobrena nova hrana
Heavy Metals
Specifikacija
Lead: < 0,1 mg/kg
Opis
Cadmium: < 0,2 mg/kg
Bazični izolat bjelančevine sirutke iz mlijeka goveda je žućkastosivi prah, dobiven iz obranog mlijeka goveda nizom koraka za izolaciju i pročišćavanje.
Mercury: < 0,6 mg/kg
Svojstva/sastav
Arsenic: < 0,1 mg/kg
Ukupno bjelančevine (m/masa proizvoda): ≥ 90 %
Microbiological criteria:
Laktoferin (m/masa proizvoda): 25-75 %
Aerobic mesophilic count: ≤ 10000 CFU/g
Laktoperoksidaza (m/masa proizvoda): 10–40 %
Escherichia coli: Negative/g
Ostale bjelančevine (m/masa proizvoda): ≤ 30 %
Coagulase positive Staphylococci: Negative/g
TGF-β2: 12–18 mg/100 g
Salmonella: Negative/25 g
Vlaga: ≤ 6,0 %
Listeria: Negative/25 g
pH (5 % otopina m/v): 5,5–7,6
Cronobacter spp.: Negative/25 g
Laktoza: ≤ 3,0 %
Moulds: ≤ 50 CFU/g
Masti: ≤ 4,5 %
Yeasts: ≤ 50 CFU/g
Pepeo: ≤ 3,5 %
CFU : Colony Forming Units’
Željezo: ≤ 25 mg/100 g
Authorised on 20 November 2018.
Teški metali
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Olovo: < 0,1 mg/kg
On 27 June 2017, the competent authority of Ireland issued its initial assessment report.
Aerobni mezofili ukupno: ≤ 10000 CFU/g
In that report, it concluded that bovine milk basic whey protein isolate meets the criteria for a novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.
Escherichia coli: negativan nalaz/g
Spézia (2012).
Koagulaza-pozitivni stafilokoki: negativan nalaz/g
Armor Protéines (2013).
Salmonella: negativan nalaz/25 g
Schmitt & Mireaux (2008).
Listeria: negativan nalaz/25 g
Sire, G. (2012a).
Cronobacter spp.: negativan nalaz/25 g
Sire, G. (2012b).
Plijesni: ≤ 50 CFU/g
authorising the placing on the market of refined shrimp peptide concentrate 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 rafiniranog koncentrata peptida kozice kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, and in particular Article 12 thereof,
uzimajući u obzir Uredbu (EU) 2015/2283 Europskog parlamenta i Vijeća od 25. studenoga 2015. o novoj hrani, o izmjeni Uredbe (EU) br. 1169/2011 Europskog parlamenta i Vijeća i o stavljanju izvan snage Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća i Uredbe Komisije (EZ) br. 1852/2001, a posebno njezin članak 12.,
Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 establishing a Union list of authorised novel foods was adopted.
U skladu s člankom 8.
On 22 December 2016, the company Marealis AS (‘the Applicant’) made a request to the competent authority of Finland to place refined shrimp peptide concentrate produced from the enzymatic hydrolysis of Northern shrimp (Pandalus borealis) shells and heads, 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 seeks to have refined shrimp peptide concentrate used in food supplements for the general adult population.
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 Marealis AS („podnositelj zahtjeva”) podnijelo je 22. prosinca 2016. nadležnom tijelu Finske zahtjev za stavljanje na tržište Unije rafiniranog koncentrata peptida kozice dobivenog enzimskom hidrolizom ljuštura i glava sjeverne kozice (Pandalus borealis) 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 refined shrimp peptide concentrate 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 rafiniranog koncentrata peptida kozice u dodacima prehrani za opću odraslu populaciju.
On 8 March 2017, the competent authority of Finland issued its initial assessment report.
U skladu s člankom 35. stavkom 1.
In that report, it concluded that refined shrimp peptide concentrate 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 13 March 2017, 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 u skladu s Uredbom (EU) 2015/2283.