natgillin/translations-raw huggingface dataset:
In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 11 December 2017, asking it to carry out an additional assessment for bovine milk basic whey protein isolate as a novel food ingredient in accordance with Regulation (EC) No 258/97.
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.
In a subsequent application submitted on 3 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 two human clinical studies with a bovine milk basic whey protein isolate, an in vitro bacterial reverse mutation assay, an in vitro mammalian cell micronucleus test, a 90-day oral toxicity study in rats, a 6-week developmental toxicity study in juvenile rats, and the electrophoresis analysis of bovine milk basic whey protein isolate.
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.
On 27 June 2018, the Authority adopted ‘Scientific Opinion on the safety of bovine milk basic whey protein isolate as a novel food pursuant to Regulation (EU) 2015/2283’.
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”.
That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
To je mišljenje u skladu sa zahtjevima iz članka 11. Uredbe (EU) 2015/2283.
That opinion gives sufficient grounds to establish that bovine milk basic whey protein isolate, in the proposed uses and use levels when used as an ingredient in infant and follow-on formulae, in total diet replacement foods for weight control, in foods for special medical purposes, and in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.
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. Uredbe (EU) 2015/2283.
In its opinion on bovine milk basic whey protein isolate, the Authority considered that the data from the 90-day oral toxicity study in rats served as a basis to establish a reference point and to assess whether the margin of exposure in relation to the proposed maximum intake of the novel food by humans is sufficient.
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.
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.
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.
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.
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.
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.
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 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.
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. Uredbe (EU) 2015/2283.
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.
U skladu s tim, kako je predviđeno člankom 26. stavkom 2. 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.
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.
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.
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.
Budući da je nova hrana proizvedena iz mlijeka, koje je u Prilogu II. 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.
The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Directive.
Uporabu bazičnog izolata bjelančevine sirutke iz mlijeka goveda trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Regulation.
Uporabu bazičnog izolata bjelančevine sirutke iz mlijeka goveda trebalo bi odobriti ne dovodeći u pitanje tu uredbu.
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.
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.
Company: Armor Protéines S.A.S.
društvu: Armor Protéines S.A.S.,
Address: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France
s adresom: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, Francuska
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.
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 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.
Unos na popis Unije iz stavka 1. uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
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.
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. 609/2013.
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.
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. 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.
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).
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.).
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).
Uredba (EZ) br. 258/97 Europskog parlamenta i Vijeća od 27. siječnja 1997. o novoj hrani i sastojcima nove hrane (SL L 43, 14.2.1997., str. 1.).
EFSA Journal 2018; 16(7):5360.
EFSA Journal 2018.; 16(7):5360.
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).
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.).
‘Bovine milk basic whey protein isolate
„Bazični izolat bjelančevine sirutke iz mlijeka goveda
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”.
Pri označivanju hrane koja sadržava novu hranu navodi se ‚Izolat bjelančevine sirutke iz mlijeka’.
Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:
Dodaci prehrani koji sadržavaju bazični izolat bjelančevine sirutke iz mlijeka goveda nose sljedeću izjavu:
“This food supplement should not be consumed by children/adolescents under the age of three/eighteen (*) years”
‚Ovaj dodatak prehrani ne smiju konzumirati djeca/adolescenti mlađi od tri/osamnaest (*) godina.’
Depending on the age group the food supplement is intended for.
Ovisno o dobnoj skupini kojoj je dodatak prehrani namijenjen.
Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France
Podnositelj zahtjeva: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, Francuska
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..
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. Uredbe (EU) 2015/2283 ili uz suglasnost društva Armor Protéines S.A.S.
End date of the data protection: 20 November 2023.’
Datum završetka zaštite podataka: 20. studenoga 2023.”
Infant formulae as defined in Regulation (EU) No 609/2013
Početna hrana za dojenčad u smislu Uredbe (EU) br. 609/2013
30 mg/100 g (powder)
30 mg/100 g (prah)
3,9 mg/100 mL (reconstituted)
3,9 mg/100 ml (rekonstituirana hrana)
Follow-on formulae as defined in Regulation (EU) No 609/2013
Prijelazna hrana za dojenčad u smislu Uredbe (EU) br. 609/2013
4,2 mg/100 mL (reconstituted)
4,2 mg/100 ml (rekonstituirana hrana)
58 mg/day for young children
58 mg dnevno za malu djecu
380 mg/day for children and adolescents from 3 to 18 years of age
380 mg dnevno za djecu i adolescente u dobi od 3 do 18 godina
610 mg/day for adults
610 mg dnevno za odrasle
250 mg/day for children and adolescents from 3 to 18 years of age
250 mg dnevno za djecu i adolescente u dobi od 3 do 18 godina
Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.
Bazični izolat bjelančevine sirutke iz mlijeka goveda je žućkastosivi prah, dobiven iz obranog mlijeka goveda nizom koraka za izolaciju i pročišćavanje.
Total protein (w/weight of product): ≥ 90 %
Ukupno bjelančevine (m/masa proizvoda): ≥ 90 %
Lactoferrin (w/weight of product): 25-75 %
Laktoferin (m/masa proizvoda): 25-75 %
Lactoperoxidase (w/weight of product): 10-40 %
Laktoperoksidaza (m/masa proizvoda): 10–40 %
Other proteins (w/weight of product): ≤ 30 %
Ostale bjelančevine (m/masa proizvoda): ≤ 30 %
TGF-β2: 12-18 mg/100 g
TGF-β2: 12–18 mg/100 g
Moisture: ≤ 6,0 %
Vlaga: ≤ 6,0 %
pH (5 % solution w/v): 5,5 – 7,6
pH (5 % otopina m/v): 5,5–7,6
Lactose: ≤ 3,0 %
Laktoza: ≤ 3,0 %
Fat: ≤ 4,5 %
Masti: ≤ 4,5 %
Ash: ≤ 3,5 %
Pepeo: ≤ 3,5 %
Iron: ≤ 25 mg/100 g
Željezo: ≤ 25 mg/100 g
Cadmium: < 0,2 mg/kg
Kadmij: < 0,2 mg/kg
Mercury: < 0,6 mg/kg
Živa: < 0,6 mg/kg
Arsenic: < 0,1 mg/kg
Arsen: < 0,1 mg/kg
Aerobic mesophilic count: ≤ 10000 CFU/g
Aerobni mezofili ukupno: ≤ 10000 CFU/g
Escherichia coli: Negative/g
Escherichia coli: negativan nalaz/g
Coagulase positive Staphylococci: Negative/g
Koagulaza-pozitivni stafilokoki: negativan nalaz/g
Salmonella: Negative/25 g
Salmonella: negativan nalaz/25 g
Listeria: Negative/25 g
Listeria: negativan nalaz/25 g
Cronobacter spp.: Negative/25 g
Cronobacter spp.: negativan nalaz/25 g
Moulds: ≤ 50 CFU/g
Plijesni: ≤ 50 CFU/g
Yeasts: ≤ 50 CFU/g
Kvasci: ≤ 50 CFU/g
CFU : Colony Forming Units’
CFU : jedinice koje tvore kolonije”
Enterobacteriaceae: ≤ 10 CFU/g
Enterobakterije: ≤ 10 CFU/g
Spézia (2012).
Spézia (2012.).
Armor Protéines (2013).
Armor Protéines (2013.).
Schmitt & Mireaux (2008).
Schmitt & Mireaux (2008.).
Sire, G. (2012a).
Sire, G. (2012.a).
Sire, G. (2012b).
Sire, G. (2012.b).
Silvano (2012).
Silvano (2012.).
Armor Protéines (2017).
Armor Protéines (2017.).
Commission Implementing Regulation (EU) 2018/1633
Provedbena uredba Komisije (EU) 2018/1633
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
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. Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.
U skladu s člankom 12. Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
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.
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.
The application seeks to have refined shrimp peptide concentrate used in food supplements for the general adult population.
U zahtjevu se traži da se odobri upotreba rafiniranog koncentrata peptida kozice u dodacima prehrani za opću odraslu populaciju.
Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients, and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.
U skladu s člankom 35. stavkom 1. Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište u Uniji koji su podneseni državi članici u skladu s člankom 4. Uredbe (EZ) br. 258/97 o novoj hrani i sastojcima nove hrane i za koje nije donesena konačna odluka prije 1. siječnja 2018. tretiraju se kao zahtjevi u skladu s Uredbom (EU) 2015/2283.
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.
Zahtjev za stavljanje na tržište u Uniji rafiniranog koncentrata peptida kozice kao nove hrane podnesen je državi članici u skladu s člankom 4. Uredbe (EZ) br. 258/97 te ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
On 8 March 2017, the competent authority of Finland issued its initial assessment report.
Nadležno tijelo Finske izdalo je 8. ožujka 2017. izvješće o početnoj ocjeni.
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.
U tom je izvješću zaključilo da rafinirani koncentrat peptida kozice ispunjava kriterije za novi sastojak hrane utvrđene u članku 3. stavku 1. Uredbe (EZ) br. 258/97.
On 13 March 2017, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 13. ožujka 2017. izvješće o početnoj ocjeni proslijedila ostalim državama članicama.
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 safety of refined shrimp peptide concentrate for hypo-, normo-, and hyper-tensive consumers due to its putative antihypertensive effects, its potential side effects related to its postulated inhibition of the angiotensin converting enzyme (ACE) and potential cardiac effects, and its potential interactions with medicines used in the treatment of blood pressure disorders.
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 sigurnosti rafiniranog koncentrata peptida kozice za potrošače s hipotenzijom, normotenzijom i hipertenzijom zbog njegovih navodnih antihipertenzijskih učinaka, mogućih nuspojava povezanih s pretpostavljenom inhibicijom angiotenzin-konvertirajućeg enzima (ACE) i mogućih učinaka na srce te mogućih interakcija s lijekovima koji se upotrebljavaju u liječenju poremećaja krvnog tlaka.
In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 21 September 2017, asking it to carry out an additional assessment for refined shrimp peptide concentrate as novel food ingredient in accordance with Regulation (EC) No 258/97.
S obzirom na prigovore koje su uložile ostale države članice, Komisija je 21. rujna 2017. zatražila od Europske agencije za sigurnost hrane („Agencija”) da provede dodatnu ocjenu rafiniranog koncentrata peptida kozice kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97.