natgillin/translations-raw huggingface dataset:
On 7 June 2017 the Commission informed the applicant of its and certain Member States' positions that, in view of the risk that infants, toddlers and children of below 19 years of age could consume the intended products, an authorisation would require an additional safety evaluation for these age groups.
Komisija je 7. lipnja 2017. obavijestila podnositelja zahtjeva o svojem stajalištu i stajalištu pojedinih država članica da bi, s obzirom na mogućnost konzumacije predmetnih proizvoda od strane novorođenčadi, male djece i djece mlađe od 19 godina, prije odobrenja bilo potrebno provesti dodatno vrednovanje sigurnosti za te dobne skupine.
Alternatively, the Commission suggested that the risk of consumption by the age groups for which the Authority had not concluded on safety could be sufficiently contained, if cranberry extract would be authorised as a novel food supplement for the adult population.
Komisija je napomenula da bi druga mogućnost da se rizik konzumacije u dobnim skupinama za koje Agencija nije potvrdila sigurnost dostatno ograniči bila da se ekstrakt brusnice odobri kao novi dodatak prehrani za odraslu populaciju.
On 22 December 2017, the Applicant informed the Commission of its decision to, at this stage, pursue the authorisation of cranberry extract for use in food supplements for the general adult population, without prejudice to a subsequent further application for an extension of the conditions of use based on a further safety assessment by the Authority.
Podnositelj zahtjeva je 22. prosinca 2017. obavijestio Komisiju o svojoj odluci da zasada zatraži odobrenje ekstrakta brusnice samo za upotrebu u dodacima prehrani za opću odraslu populaciju, ne dovodeći u pitanje budući dodatni zahtjev za proširenje uvjeta upotrebe na temelju dodatne ocjene sigurnosti Agencije.
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.The application also meets the requirements laid down in 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 i za koje nije donesena konačna odluka prije 1. siječnja 2018. tretiraju se kao zahtjevi u skladu s Uredbom (EU) 2015/2283. Zahtjev ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
The opinion of the Authority gives sufficient grounds to establish that cranberry extract powder, when used in food supplements for general adult population, complies with Article 12(1) of Regulation (EU) 2015/2283.
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. Uredbe (EU) 2015/2283 kada se upotrebljava u dodacima prehrani za opću odraslu populaciju.
On 2 May 2018, the applicant made a request to the Commission for protection of proprietary data for three studies submitted in support of the application namely, a ten-week clinical study in healthy adults, a twelve-week clinical study in adults with low to moderate cardiovascular disease risk and a report on the influence on systemic immune functions, urinary and systemic biomarkers of health and faecal characteristics of human subjects during a 10 weeks administration.
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.
The applicant also made a request to the Commission for protection of proprietary data for consumption information of their cranberry juice cocktail product in Europe, as well as consumption information relating to children.
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.
A request to the Commission for protection of proprietary data was also made for the compositional data and the intake estimate on cranberry beverage consumption.
Zahtjev Komisiji podnesen je i za zaštitu vlasnički zaštićenih podataka o sastavu i procjeni unosa pri konzumaciji napitka od brusnice.
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.
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.
Therefore, it is considered that the conclusions on the safety of cranberry extract powder could not have been reached without the aforementioned data.
Stoga se smatra da zaključci o sigurnosti ekstrakta brusnice u prahu ne bi mogli biti doneseni bez prethodno navedenih podataka.
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.
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.
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.
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.
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.
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. Uredbe (EU) 2015/2283.
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.
U skladu s tim, kako je predviđeno u članku 26. stavku 2. 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.
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.
Slijedom toga, stavljanje na tržište u Uniji nove hrane odobrene ovom Uredbom trebalo bi ograničiti na podnositelja zahtjeva tijekom razdoblja od pet godina.
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.
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.
Directive 2002/46/EC lays down requirements on food supplements.
Direktivom 2002/46/EZ utvrđeni su zahtjevi o dodacima prehrani.
The use of cranberry extract powder should be authorised without prejudice to the requirements of that Directive.
Upotrebu ekstrakta brusnice u prahu trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
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.
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.
For a period of five years from the date of entry into force of this Regulation only the Applicant:
Tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe isključivo je podnositelju zahtjeva,
Company: Ocean Spray Cranberries Inc.
društvu: Ocean Spray Cranberries Inc.
Address: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA
adresa: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, SAD
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.
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.
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 Unijin popis iz stavka 1. uključuje uvjete upotrebe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
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.
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. 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.
EFSA Journal 2017.; 15(5):4777.
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).
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.).
Nantz et al., unpublished manuscript.
Nantz i dr., neobjavljeni rukopis.
Juturu et al., unpublished manuscript.
Juturu i dr., neobjavljeni rukopis.
Unpublished Report.
Neobjavljeno izvješće.
Original application, dated June 2011.
Izvorni zahtjev, lipanj 2011.
Table IX.b-1, Original application, dated June 2011, page 24.
Tablica IX.b–1. Izvorni zahtjev, lipanj 2011., stranica 24.
Ocean Spray's response to Member States' objections, dated November 2015.
Odgovor društva Ocean Spray na prigovore država članica, studeni 2015.
The following last column is added in Table 1 (Authorised novel foods):
Sljedeći zadnji stupac dodaje se u tablicu 1. (Odobrena nova hrana):
Cranberry extract powder
Ekstrakt brusnice u prahu
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’
Pri označivanju hrane koja sadržava novu hranu navodi se „ekstrakt brusnice u prahu”.
Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA
Podnositelj zahtjeva: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, SAD
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.
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. Uredbe (EU) 2015/2283 ili uz suglasnost društva Ocean Spray Cranberries Inc.
End date of the data protection: 20 November 2023.’
Datum prestanka zaštite podataka: 20. studenoga 2023.”
Food Supplements as defined in Directive 2002/46/EC for the adult population
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni odrasloj populaciji
350 mg/day
350 mg dnevno
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.
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.
Moisture (% w/w): ≤ 4
Vlaga (% m/m): ≤ 4
Proanthocyanidins — PACs (% w/w dry weight)
Proantocijanidini (PAC) (% m/m suhe tvari)
OSC-DMAC method: 55.0-60.0 or
Metoda OSC-DMAC: 55,0–60,0 ili
BL-DMAC method: 15.0-18.0
Metoda BL-DMAC: 15,0–18,0
Total phenolics (GAE, % w/w dry weight)
Ukupni fenoli (GAE, % m/m suhe tvari)
Folin-Ciocalteau method: > 46.2
Metoda Folin–Ciocalteau: > 46,2
Solubility (water): 100 %, with no visible insoluble particles
Topivost (voda): 100 % bez vidljivih netopivih čestica
Ethanol Content (mg/kg): ≤ 100
Sadržaj etanola (mg/kg) ≤ 100
Screen Analysis: 100 % through 30 mesh screen
Analiza s pomoću sita: 100 % kroz sito s 30 otvora
Appearance and aroma, as powder: Free-flowing, deep red colour. Earthy aroma with no burnt character.
Izgled i miris, u obliku praha: Slobodno teče, tamnocrvene boje Zemljani miris bez mirisa paljevine.
Arsenic (ppm): < 3
Arsen (ppm): < 3
Yeast: < 100 CFU/g
Kvasac: < 100 CFU/g
Mould: < 100 CFU/g
Plijesan: < 100 CFU/g
Aerobic plate count: < 1000 CFU/g
Broj aerobnih kolonija: < 1000 CFU/g
Salmonella: Absent in 375 g
Salmonella: Nije prisutno u 375 g
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.
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.
The different values for these three parameters are due to the different methods used.
Različite vrijednosti za ta tri parametra posljedica su primjene različitih metoda.
GAE: Gallic Acid Equivalents
GAE: Ekvivalenti galne kiseline
EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of XXX. Plenary held on 28-29 June 2018.
Znanstveni odbor EFSA-e za dijetetske proizvode, prehranu i alergije, zapisnik s XXX. plenarne sjednice održane 28. i 29. lipnja 2018.
Authorised on 20 November 2018.
Odobreno 20. studenoga 2018.
Modified from Cunningham DG, Vannozzi S, O'Shea E, Turk R (2002) In: Ho C-T, Zheng QY (eds) Quality Management of Nutraceuticals ACS Symposium series 803, Washington DC.
Modificirano prema Cunningham DG, Vannozzi S, O'Shea E, Turk R (2002.). U: Ho C-T, Zheng QY (eds) Quality Management of Nutraceuticals ACS Symposium series 803, Washington DC.
Quantitation of PACs by DMAC Color Reaction pp 151-166.
Quantitation of PACs by DMAC Color Reaction str. 151.–166.
BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders. Prior RL, Fan E, Ji H, Howell A, Nio C, Payne MJ, Reed J. J Sci Food Agric.
Metoda BL-DMAC 4-dimetilaminocinamaldehid (Brunswick Lab) Međulaboratorijska validacija standardne metode za kvantifikaciju proantocijanidina u brusnici u prahu.
2010 Jul;90(9):1473-8.
Prior RL, Fan E, Ji H, Howell A, Nio C, Payne MJ, Reed J. J Sci Food Agric. srpanj 2010.;90(9):1473-8.
Commission Implementing Regulation (EU) 2018/1632
Provedbena uredba Komisije (EU) 2018/1632
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. Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470, kojom je utvrđen Unijin popis odobrene nove hrane.
On 22 August 2016, the company Armor Protéines S.A.S.
Društvo Armor Protéines S.A.S.
(‘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.
(„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.
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.
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.
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.
Na temelju članka 35. stavka 1. Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište Unije 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 podneseni u skladu s Uredbom (EU) 2015/2283.
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.
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. Uredbe (EZ) br. 258/97, a ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
On 27 June 2017, the competent authority of Ireland issued its initial assessment report.
Nadležno tijelo Irske izdalo je 27. lipnja 2017. izvješće o početnoj procjeni.
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.
U tom je izvješću zaključeno da bazični izolat bjelančevine sirutke iz mlijeka goveda ispunjava kriterije za novi sastojak hrane utvrđene člankom 3. stavkom 1. Uredbe (EZ) br. 258/97.
On 4 July 2017, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 4. srpnja 2017. izvješće o početnoj procjeni 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 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.
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.