natgillin/translations-raw huggingface dataset:
On 27 June 2018, the Authority considered that in elaborating its opinion on cranberry extract powder as a novel food, the compositional information (Table IX.b-1, original application, dated June 2011, page 24) and the intake estimate on cranberry beverage consumption (File: ‘Ocean Spray's response to Member States' objections’, dated November 2015) were needed for the characterisation and setting of specifications of the novel food, as well as for hazard identification, and for the assessment whether the potential intake of proanthocyanidins (PAC) from the novel food is comparable to the PAC intake from the consumption of cranberry juice products.
Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište u Uniji koji su podneseni državi članici u skladu s člankom 4.
Therefore, it is considered that the conclusions on the safety of cranberry extract powder could not have been reached without the aforementioned data.
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.
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 data, and their claim to an exclusive right of reference to that data, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
Zahtjev ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
The applicant declared that, at the time the application was submitted, it held proprietary and exclusive rights of reference to the evidence and data under national law and that therefore third parties could not lawfully access or use that scientific evidence or scientific data.
U mišljenju Agencije iznosi se dovoljno informacija na temelju kojih se može utvrditi da je ekstrakt brusnice u prahu u skladu s člankom 12. stavkom 1.
The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283 kada se upotrebljava u dodacima prehrani za opću odraslu populaciju.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the compositional data and the intake estimate 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 for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation.
Podnositelj zahtjeva Komisiji je 2. svibnja 2018. podnio zahtjev za zaštitu vlasnički zaštićenih podataka za tri studije koje je dostavio u potporu zahtjevu, i to studiju o desetotjednom kliničkom ispitivanju na zdravim odraslim osobama, studiju o dvanaestotjednom kliničkom ispitivanju na odraslim osobama s malim do umjerenim rizikom od kardiovaskularnih bolesti i izvješće o utjecaju na sistemske funkcije imunološkog sustava, urinarne i sistemske biomarkere zdravstvenog stanja i značajke stolice kod ljudi tijekom desetotjedne primjene.
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.
Podnositelj zahtjeva Komisiji je podnio i zahtjev za zaštitu vlasnički zaštićenih podataka u vezi s informacijama o konzumaciji za njegov koktel soka od brusnice u Europi te informacijama o konzumaciji koje se odnose na djecu.
However, restricting the authorisation of this novel food and of the reference to the scientific evidence or scientific data 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.
Zahtjev Komisiji podnesen je i za zaštitu vlasnički zaštićenih podataka o sastavu i procjeni unosa pri konzumaciji napitka od brusnice.
Directive 2002/46/EC lays down requirements on food supplements.
Agencija je 27. lipnja 2018. zaključila da su pri izradi njezina mišljenja o ekstraktu brusnice u prahu kao novoj hrani informacije o sastavu (tablica IX.b–1., izvorni zahtjev, lipanj 2011., stranica 24.) i procjena unosa pri konzumaciji napitka od brusnica (dokumentacija: Odgovor društva Ocean Spray na prigovore država članica, studeni 2015.) bile potrebne za opis svojstava i utvrđivanje specifikacija nove hrane, za identifikaciju opasnosti te za ocjenu je li mogući unos proantocijanidina (PAC) iz nove hrane usporediv s unosom PAC-a pri konzumaciji proizvoda od soka brusnice.
The use of cranberry extract powder should be authorised without prejudice to the requirements of that Directive.
Stoga se smatra da zaključci o sigurnosti ekstrakta brusnice u prahu ne bi mogli biti doneseni bez prethodno navedenih podataka.
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 dano obrazloženje u pogledu njegova zahtjeva za zaštitu vlasnički zaštićenih podataka i zahtjev za isključivo pravo upućivanja na te podatke, kako je navedeno u članku 26. stavku 2. točkama (a) i (b) Uredbe (EU) 2015/2283.
HAS ADOPTED THIS REGULATION:
Podnositelj zahtjeva izjavio je da je u trenutku podnošenja zahtjeva bio nositelj vlasničkih i isključivih prava upućivanja na dokaze i podatke u skladu s nacionalnim pravom te da stoga treće osobe nisu mogle imati zakonit pristup tim znanstvenim dokazima i podacima niti se koristiti njima.
Article 1
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.
Cranberry extract powder 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.
For a period of five years from the date of entry into force of this Regulation only the Applicant:
U skladu s tim, kako je predviđeno u članku 26. stavku 2.
Company: Ocean Spray Cranberries Inc.
Uredbe (EU) 2015/2283, Agencija podatke o sastavu i procjeni unosa, koji su sadržani u dokumentaciji podnositelja zahtjeva i bez kojih 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.
Address: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA
Slijedom toga, stavljanje na tržište u Uniji nove hrane odobrene ovom Uredbom trebalo bi ograničiti na podnositelja zahtjeva tijekom razdoblja od pet godina.
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 same novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Ocean Spray Cranberries Inc.
Međutim, ograničenje odobrenja te nove hrane i upućivanja na znanstvene dokaze ili znanstvene podatke sadržane 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.
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.
Direktivom 2002/46/EZ 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 ekstrakta brusnice u prahu trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The data 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 (EC) No 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 Ocean Spray Cranberries Inc.
DONIJELA JE OVU UREDBU:
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Ekstrakt brusnice u prahu, 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 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: Ocean Spray Cranberries Inc.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
adresa: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, SAD
Done at Brussels, 30 October 2018.
odobreno stavljati na tržište u Uniji novu hranu iz stavka 1., osim ako budući podnositelj zahtjeva dobije odobrenje za istu novu hranu bez upućivanja na podatke zaštićene u skladu s člankom 2. ove Uredbe ili uz suglasnost društva Ocean Spray Cranberries Inc.
For the Commission
Unos na Unijin popis iz stavka 1. uključuje uvjete upotrebe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
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).
Podaci iz dokumentacije podnositelja zahtjeva na temelju kojih je Agencija ocijenila novu hranu iz članka 1., i za koje podnositelj zahtjeva tvrdi da ispunjavaju zahtjeve utvrđene u članku 26. stavku 2.
Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p. 1).
Uredbe (EU) 2015/2283, ne smiju se upotrebljavati u korist budućih podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe bez suglasnosti društva Ocean Spray Cranberries Inc.
EFSA Journal 2017; 15(5):4777.
Članak 3.
Food supplements are subject to specific labelling and marketing requirements pursuant to 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).
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se u skladu s Prilogom ovoj Uredbi.
Nantz et al., unpublished manuscript.
Članak 4.
Juturu et al., unpublished manuscript.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Unpublished Report.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Original application, dated June 2011.
Sastavljeno u Bruxellesu 30. listopada 2018.
Table IX.b-1, Original application, dated June 2011, page 24.
Za Komisiju
Ocean Spray's response to Member States' objections, dated November 2015.
Predsjednik
ANNEX
Uredba (EZ) br. 258/97 Europskog parlamenta i Vijeća o novoj hrani i sastojcima nove hrane (SL L 43, 14.2.1997., str. 1.).
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
EFSA Journal 2017.; 15(5):4777.
The following last column is added in Table 1 (Authorised novel foods):
Dodaci prehrani podliježu posebnim zahtjevima za označivanje i stavljanje na tržište u skladu s Direktivom 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.).
‘Data protection’
Nantz i dr., neobjavljeni rukopis.
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
Juturu i dr., neobjavljeni rukopis.
‘Authorised novel food
Neobjavljeno izvješće.
Conditions under which the novel food may be used
Izvorni zahtjev, lipanj 2011.
Additional specific labelling requirements
Tablica IX.b–1.
Other requirements
Izvorni zahtjev, lipanj 2011., stranica 24.
Data protection
Odgovor društva Ocean Spray na prigovore država članica, studeni 2015.
Cranberry extract powder
PRILOG
Maximum levels
Sljedeći zadnji stupac dodaje se u tablicu 1.
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’
(Odobrena nova hrana):
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Sljedeći unos umeće se abecednim redom u tablicu 1.
Applicant: Ocean Spray Cranberries Inc.
(Odobrena nova hrana):
One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA
„Odobrena nova hrana
During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc. 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 Ocean Spray Cranberries Inc.
Uvjeti pod kojima se nova hrana može upotrebljavati
End date of the data protection: 20 November 2023.’
Dodatni posebni zahtjevi za označivanje proizvoda
Food Supplements as defined in Directive 2002/46/EC for the adult population
Ostali zahtjevi
350 mg/day
Zaštita podataka
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Ekstrakt brusnice u prahu
‘Authorised Novel Food
Određena kategorija hrane
Specification
Najveće dopuštene količine
Description/Definition:
Pri označivanju hrane koja sadržava novu hranu navodi se „ekstrakt brusnice u prahu”.
Cranberry extract powder is a water-soluble phenolic-rich powder extract prepared through an ethanolic extraction from the juice concentrate of sound, mature berries of the cranberry cultivar Vaccinium macrocarpon.
Podnositelj zahtjeva: Ocean Spray Cranberries Inc.
Characteristics/Composition
One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, SAD
Moisture (% w/w): ≤ 4
Tijekom razdoblja zaštite podataka stavljanje na tržište u Uniji nove hrane ekstrakt brusnice u prahu odobreno je isključivo podnositelju zahtjeva Ocean Spray Cranberries Inc., osim ako budući podnositelj zahtjeva dobije odobrenje za tu novu hranu bez upućivanja na vlasnički zaštićene znanstvene dokaze ili znanstvene podatke zaštićene u skladu s člankom 26.
Proanthocyanidins — PACs (% w/w dry weight)
Uredbe (EU) 2015/2283 ili uz suglasnost društva Ocean Spray Cranberries Inc.
OSC-DMAC method: 55.0-60.0 or
Datum prestanka zaštite podataka: 20. studenoga 2023.”
BL-DMAC method: 15.0-18.0
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni odrasloj populaciji
Total phenolics (GAE, % w/w dry weight)
350 mg dnevno
Folin-Ciocalteau method: > 46.2
Sljedeći unos umeće se abecednim redom u tablicu 2.
Solubility (water): 100 %, with no visible insoluble particles
(Specifikacije):
Ethanol Content (mg/kg): ≤ 100
„Odobrena nova hrana
Screen Analysis: 100 % through 30 mesh screen
Specifikacija
Appearance and aroma, as powder: Free-flowing, deep red colour.
Opis/definicija:
Earthy aroma with no burnt character.
Ekstrakt brusnice u prahu je fenolima bogat ekstrakt u prahu koji je topiv u vodi, a koji se dobiva etanolnom ekstrakcijom iz koncentrata soka zdravih zrelih bobica kultivara brusnice Vaccinium macrocarpon.
Heavy metals:
Svojstva/sastav
Arsenic (ppm): < 3
Vlaga (% m/m): ≤ 4
Microbiological criteria:
Proantocijanidini (PAC) (% m/m suhe tvari)
Yeast: < 100 CFU/g
Metoda OSC-DMAC: 55,0–60,0 ili
Mould: < 100 CFU/g
Metoda BL-DMAC: 15,0–18,0
Aerobic plate count: < 1000 CFU/g
Ukupni fenoli (GAE, % m/m suhe tvari)
Salmonella: Absent in 375 g
Topivost (voda): 100 % bez vidljivih netopivih čestica
OSC-DMAC (4-dimethylaminocinnamaldehyde) method (Ocean Spray Cranberries, Inc) Martin MA, Ramos S, Mateos R, Marais JPJ, Bravo-Clemente, L, Khoo C and Goya L. Food Res Intl 2015 71: 68-82.
Sadržaj etanola (mg/kg) ≤ 100
BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders.
Analiza s pomoću sita: 100 % kroz sito s 30 otvora
The different values for these three parameters are due to the different methods used.
Izgled i miris, u obliku praha: Slobodno teče, tamnocrvene boje Zemljani miris bez mirisa paljevine.
GAE: Gallic Acid Equivalents
Teški metali:
CFU: Colony Forming Units’
Arsen (ppm): < 3
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Broj aerobnih kolonija: < 1000 CFU/g
Appearance and aroma, as powder: Free-flowing, deep red colour.
Koliformi: < 10 CFU/g
Earthy aroma with no burnt character.
Salmonella: Nije prisutno u 375 g
Escherichia coli: < 10 CFU/g
Metoda OSC-DMAC (4-dimetilaminocinamaldehid) (Ocean Spray Cranberries, Inc) Martin MA, Ramos S, Mateos R, Marais JPJ, Bravo-Clemente, L, Khoo C i Goya L. Food Res Intl 2015 71: 68-82.
authorising the placing on the market of bovine milk basic whey protein isolate 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 bazičnog izolata bjelančevine sirutke iz mlijeka goveda 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.
Na temelju članka 8.
On 22 August 2016, the company Armor Protéines S.A.S.
Na temelju članka 12.
(‘the Applicant’) made a request to the competent authority of Ireland to place bovine milk basic whey protein isolate obtained from skimmed bovine milk through a series of purification steps, 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.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
The application seeks to have bovine milk basic whey protein isolate used in infant and follow-on formulae, in total diet replacement foods for weight control and in foods for special medical purposes, and in food supplements.
Društvo Armor Protéines S.A.S.
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.
(„podnositelj zahtjeva”) podnijelo je 22. kolovoza 2016. nadležnom tijelu Irske zahtjev za stavljanje na tržište Unije bazičnog izolata bjelančevine sirutke, dobivenog iz obranog mlijeka goveda nizom postupaka pročišćavanja, 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 bovine milk basic whey protein isolate 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.
Podnositelj zahtjeva želi bazični izolat bjelančevine sirutke iz mlijeka goveda upotrebljavati u početnoj i prijelaznoj hrani za dojenčad, zamjeni za cjelodnevnu prehranu pri redukcijskoj dijeti, hrani za posebne medicinske potrebe i dodacima prehrani.
On 27 June 2017, the competent authority of Ireland issued its initial assessment report.
Na temelju članka 35. stavka 1.
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.
Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište Unije koji su podneseni državi članici u skladu s člankom 4.
On 4 July 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 podneseni 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 safety of bovine milk basic whey protein isolate for infants, and the toxicological relevance of the results in a 6-week developmental toxicity study in juvenile rats.
Zahtjev za stavljanje na tržište Unije bazičnog izolata bjelančevine sirutke iz mlijeka goveda kao nove hrane podnesen je državi članici u skladu s člankom 4.
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.
Uredbe (EZ) br. 258/97, a ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
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.
Nadležno tijelo Irske izdalo je 27. lipnja 2017. izvješće o početnoj procjeni.
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’.
U tom je izvješću zaključeno da bazični izolat bjelančevine sirutke iz mlijeka goveda ispunjava kriterije za novi sastojak hrane utvrđene člankom 3. stavkom 1.
That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Uredbe (EZ) br. 258/97.
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.
Komisija je 4. srpnja 2017. izvješće o početnoj procjeni proslijedila ostalim državama članicama.
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.
Ostale države članice uložile su u roku od 60 dana propisanom člankom 6. stavkom 4. prvim podstavkom Uredbe (EZ) br. 258/97 obrazložene prigovore o tome je li bazični izolat bjelančevine sirutke iz mlijeka goveda siguran za dojenčad i o toksikološkoj relevantnosti rezultata šestotjedne studije razvojne toksičnosti u mladih štakora.