natgillin/translations-raw huggingface dataset:
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.
naslov: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, Združene države Amerike
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.
odobreno dajati na trg v Uniji novo živilo iz odstavka 1, razen če poznejši vložnik pridobi odobritev za isto novo živilo brez sklicevanja na podatke, zaščitene v skladu s členom 2 te uredbe, ali s privolitvijo družbe Ocean Spray Cranberries Inc.
The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
Vnos na seznamu Unije iz odstavka 1 vključuje pogoje uporabe in zahteve za označevanje, določene v Prilogi k tej uredbi.
Article 2
Odobritev iz tega člena ne posega v določbe Direktive 2002/46/ES.
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.
Člen 2
Article 3
Podatki iz vloge, na podlagi katerih je Agencija ocenila novo živilo iz člena 1 in za katere vložnik trdi, da izpolnjujejo zahteve iz člena 26(2) Uredbe (EU) 2015/2283, se v obdobju petih let od datuma začetka veljavnosti te uredbe brez privolitve družbe Ocean Spray Cranberries Inc. ne uporabijo v korist poznejšega vložnika.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Člen 3
Article 4
Priloga k Izvedbeni uredbi (EU) 2017/2470 se spremeni v skladu s Prilogo k tej uredbi.
Done at Brussels, 30 October 2018.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
For the Commission
V Bruslju, 30. oktobra 2018
OJ L 327, 11.12.2015, p. 1.
Predsednik
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).
UL L 327, 11.12.2015, str. 1.
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).
Izvedbena uredba Komisije (EU) 2017/2470 z dne 20. decembra 2017 o oblikovanju seznama Unije novih živil v skladu z Uredbo (EU) 2015/2283 Evropskega parlamenta in Sveta o novih živilih (UL L 351, 30.12.2017, str. 72).
EFSA Journal 2017; 15(5):4777.
Uredba (ES) št. 258/97 Evropskega parlamenta in Sveta v zvezi z novimi živili in novimi živilskimi sestavinami (UL L 43, 14.2.1997, str. 1).
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).
EFSA Journal 2017;15(5):4777.
Nantz et al., unpublished manuscript.
Za prehranska dopolnila veljajo posebne zahteve za označevanje in trženje iz Direktive 2002/46/ES Evropskega parlamenta in Sveta z dne 10. junija 2002 o približevanju zakonodaj držav članic o prehranskih dopolnilih (UL L 183, 12.7.2002, str. 51).
Juturu et al., unpublished manuscript.
Nantz in sod., neobjavljeno besedilo.
Unpublished Report.
Juturu in sod., neobjavljeno besedilo.
Original application, dated June 2011.
Neobjavljeno poročilo.
Table IX.b-1, Original application, dated June 2011, page 24.
Prvotna vloga iz junija 2011.
Ocean Spray's response to Member States' objections, dated November 2015.
Tabela IX.b-1, prvotna vloga iz junija 2011, stran 24.
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
v Tabeli 1 (Odobrena nova živila) se doda naslednji zadnji stolpec:
‘Data protection’
v Tabeli 1 (Odobrena nova živila) se po abecednem vrstnem redu vstavi naslednji vnos:
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
„Odobreno novo živilo
‘Authorised novel food
Pogoji za uporabo novih živil
Data protection
Izvleček brusnic v prahu
Cranberry extract powder
Določena kategorija živil
Maximum levels
Poimenovanje novega živila pri označevanju živil, ki ga vsebujejo, je „izvleček brusnic v prahu“.
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’
Vložnik: Ocean Spray Cranberries Inc.
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
V obdobju varstva podatkov je dajanje novega živila izvleček brusnic v prahu na trg v Uniji odobreno le družbi Ocean Spray Cranberries Inc., razen če poznejši vložnik pridobi odobritev za novo živilo brez sklicevanja na pravno zaščitene znanstvene dokaze ali znanstvene podatke, varovane v skladu s členom 26 Uredbe (EU) 2015/2283, ali s privolitvijo družbe Ocean Spray Cranberries Inc.
Applicant: Ocean Spray Cranberries Inc.
Končni datum obdobja varstva podatkov: 20. november 2023.“
One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA
prehranska dopolnila, kot so opredeljena v Direktivi 2002/46/ES, za odraslo populacijo
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.
350 mg/dan
End date of the data protection: 20 November 2023.’
v Tabeli 2 (Specifikacije) se po abecednem vrstnem redu vstavi naslednji vnos:
Food Supplements as defined in Directive 2002/46/EC for the adult population
„Odobreno novo živilo
350 mg/day
Specifikacije
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Opis/opredelitev:
‘Authorised Novel Food
Izvleček brusnic v prahu je vodotopen izvleček v prahu, bogat s fenoli, pripravljen z etanolno ekstrakcijo iz koncentrata soka iz trdnih in zrelih jagod kultivarja brusnic Vaccinium macrocarpon.
Specification
Značilnosti/sestava
Description/Definition:
vlaga (% m/m): ≤ 4
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.
proantocianidini (% m/m suhe snovi):
Characteristics/Composition
metoda OSC-DMAC: 55,0–60,0 ali
Moisture (% w/w): ≤ 4
metoda BL-DMAC: 15,0–18,0
Proanthocyanidins — PACs (% w/w dry weight)
fenoli skupaj (GAE, % m/m suhe snovi)
OSC-DMAC method: 55.0-60.0 or
metoda Folin-Ciocalteau: > 46,2
BL-DMAC method: 15.0-18.0
topnost (v vodi): 100 %, brez vidnih netopnih delcev
Total phenolics (GAE, % w/w dry weight)
vsebnost etanola (mg/kg): ≤ 100
Folin-Ciocalteau method: > 46.2
analiza na zaslonu: 100 % prek zaslona s 30 mrežnimi očesi
Solubility (water): 100 %, with no visible insoluble particles
Težke kovine:
Screen Analysis: 100 % through 30 mesh screen
Mikrobiološka merila:
Appearance and aroma, as powder: Free-flowing, deep red colour.
kvasovke: < 100 CFU/g
Earthy aroma with no burnt character.
plesni: < 100 CFU/g
Heavy metals:
število aerobnih mikroorganizmov na ploščah: < 1000 CFU/g
Arsenic (ppm): < 3
koliformne bakterije: < 10 CFU/g
Microbiological criteria:
Salmonella: odsotnost v 375 g
Yeast: < 100 CFU/g
Metoda OSC-DMAC (4-dimetilaminocinamaldehid) (Ocean Spray Cranberries Inc.).
Mould: < 100 CFU/g
Martin MA, Ramos S, Mateos R, Marais JPJ, Bravo-Clemente, L, Khoo C in Goya L. Food Res Intl 2015 71: 68–82.
Aerobic plate count: < 1000 CFU/g
metoda BL-DMAC (4-dimetilaminocinamaldehid) (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders (Multilaboratorijska validacija standardne metode za določanje količine proantocianidinov v brusničnih prahovih).
Coliforms: < 10 CFU/g
Različne vrednosti za te tri parametre so posledica različnih uporabljenih metod.
Salmonella: Absent in 375 g
GAE: ekvivalenti galne kisline.
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.
CFU: kolonijske enote.“
BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders.
Panel za prehrano, nova živila in živilske alergene agencije EFSA, zapisnik XXX. plenarnega zasedanja, ki je potekalo 28. in 29. junija 2018.
The different values for these three parameters are due to the different methods used.
Odobreno 20. novembra 2018.
GAE: Gallic Acid Equivalents
Ta vključitev temelji na pravno zaščitenih znanstvenih dokazih in znanstvenih podatkih, varovanih v skladu s členom 26 Uredbe (EU) 2015/2283.
CFU: Colony Forming Units’
videz in aroma, v obliki prahu: sipek, temno rdeča barva.
EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of XXX.
Zemeljska aroma brez lastnosti zažganega.
Plenary held on 28-29 June 2018.
Prilagojeno po Cunningham DG, Vannozzi S, O'Shea E, Turk R (2002) v: Ho C-T, Zheng QY (eds) Quality Management of Nutraceuticals (Nadzor kakovosti nutricevtikov) ACS Symposium series 803, Washington DC.
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
2010 Jul;90(9):1473–8.
Commission Implementing Regulation (EU) 2018/1632
Izvedbena 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 odobritvi dajanja na trg bazičnega izolata beljakovin sirotke iz kravjega mleka kot novega živila v skladu z Uredbo (EU) 2015/2283 Evropskega parlamenta in Sveta ter o spremembi Izvedbene 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.
V skladu s členom 8 Uredbe (EU) 2015/2283 je bila sprejeta Izvedbena uredba Komisije (EU) 2017/2470, s katero je bil vzpostavljen seznam Unije odobrenih novih živil.
On 22 August 2016, the company Armor Protéines S.A.S.
Družba 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.
(v nadaljnjem besedilu: vložnik) je 22. avgusta 2016 pristojnemu organu Irske predložila zahtevo za dajanje bazičnega izolata beljakovin sirotke iz kravjega mleka, pridobljenega iz posnetega kravjega mleka s serijo postopkov prečiščevanja, na trg Unije kot nove živilske sestavine v smislu točke (e) člena 1(2) Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta.
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.
Vloga se nanaša na uporabo bazičnega izolata beljakovin sirotke iz kravjega mleka v začetnih formulah za dojenčke in nadaljevalnih formulah, v popolnih prehranskih nadomestkih za nadzor nad telesno težo ter v živilih za posebne zdravstvene namene in v prehranskih dopolnilih.
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.
V skladu s členom 35(1) Uredbe (EU) 2015/2283 se kakršna koli zahteva za dajanje novega živila na trg v Uniji, ki se predloži državi članici v skladu s členom 4 Uredbe (ES) št. 258/97 v zvezi z novimi živili in novimi živilskimi sestavinami in za katero končna odločitev ni bila sprejeta pred 1. januarjem 2018, obravnava kot vloga v skladu z Uredbo (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.
Zahteva za dajanje bazičnega izolata beljakovin sirotke iz kravjega mleka na trg Unije kot novega živila je bila državi članici predložena v skladu s členom 4 Uredbe (ES) št. 258/97, vendar vloga izpolnjuje tudi zahteve iz Uredbe (EU) 2015/2283.
On 27 June 2017, the competent authority of Ireland issued its initial assessment report.
Pristojni organ Irske je 27. junija 2017 izdal poročilo o začetni presoji.
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.
V navedenem poročilu ugotavlja, da bazični izolat beljakovin sirotke iz kravjega mleka izpolnjuje merila za novo živilsko sestavino, določena v členu 3(1) Uredbe (ES) št. 258/97.
On 4 July 2017, the Commission forwarded the initial assessment report to the other Member States.
Komisija je poročilo o začetni presoji 4. julija 2017 poslala drugim državam članicam.
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.
Druge države članice so v 60-dnevnem roku iz prvega pododstavka člena 6(4) Uredbe (ES) št. 258/97 vložile upravičene ugovore glede varnosti bazičnega izolata beljakovin sirotke iz kravjega mleka za dojenčke in glede toksikološke ustreznosti rezultatov šesttedenske študije o razvojni toksičnosti pri mladih podganah.
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.
Komisija se je 11. decembra 2017 na podlagi ugovorov, ki so jih vložile druge države članice, posvetovala z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) in jo zaprosila za dodatno presojo bazičnega izolata beljakovin sirotke iz kravjega mleka kot nove živilske sestavine v skladu z Uredbo (ES) št. 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.
Vložnik je v poznejši vlogi, predloženi 3. januarja 2018, Komisijo zaprosil za varstvo pravno zaščitenih podatkov iz več študij v podporo vlogi, tj. dveh kliničnih študij na ljudeh z uporabo bazičnega izolata beljakovin sirotke iz kravjega mleka, in vitro analize bakterijske reverzne mutacije, in vitro mikrojedrnega testa sesalskih celic, 90-dnevne študije o oralni toksičnosti pri podganah, šesttedenske študije o razvojni toksičnosti pri mladih podganah ter analize elektroforeze bazičnega izolata beljakovin sirotke iz kravjega mleka.
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. junija 2018 sprejela znanstveno mnenje o varnosti bazičnega izolata beljakovin sirotke iz kravjega mleka kot novega živila na podlagi Uredbe (EU) 2015/2283 (Scientific Opinion on the safety of bovine milk basic whey protein isolate as a novel food pursuant to Regulation (EU) 2015/2283).
That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Navedeno mnenje je v skladu z zahtevami iz člena 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.
Navedeno mnenje je zadostna podlaga za ugotovitev, da je bazični izolat beljakovin sirotke iz kravjega mleka pri predlaganih načinih in ravneh uporabe, kadar se uporablja kot sestavina v začetnih formulah za dojenčke in nadaljevalnih formulah, v popolnih prehranskih nadomestkih za nadzor nad telesno težo, v živilih za posebne zdravstvene namene in v prehranskih dopolnilih, v skladu s členom 12(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 v svojem mnenju o bazičnem izolatu beljakovin sirotke iz kravjega mleka navedla, da so bili podatki iz 90-dnevne študije o oralni toksičnosti pri podganah podlaga za določitev referenčne točke in za presojo, ali je meja izpostavljenosti glede na predlagani največji vnos novega živila pri ljudeh zadostna.
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.
Zato se šteje, da brez podatkov iz poročila o tej študiji ne bi bilo mogoče priti do ugotovitev o varnosti bazičnega izolata beljakovin sirotke iz kravjega mleka.
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.
Po prejemu mnenja Agencije je Komisija od vložnika zahtevala, naj dodatno pojasni predloženo utemeljitev v zvezi s svojo zahtevo za pravno zaščitene podatke iz poročila o 90-dnevni študiji o oralni toksičnosti pri podganah in svojo zahtevo za izključno pravico do sklicevanja na to študijo, kot je navedeno v točkah (a) in (b) člena 26(2) 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.
Vložnik je prav tako izjavil, da je imel v času vložitve vloge v skladu z nacionalno zakonodajo pravno zaščitene ali izključne pravice do sklicevanja na študijo in da tretje osebe zato niso mogle zakonito dostopati ali uporabljati navedene študije.
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 ocenila vse informacije, ki jih je predložil vložnik, in ugotovila, da je ta zadovoljivo utemeljil izpolnjevanje zahtev iz člena 26(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.
V skladu s tem, kot je določeno v členu 26(2) Uredbe (EU) 2015/2283, Agencija v obdobju petih let od datuma začetka veljavnosti te uredbe ne bi smela uporabiti 90-dnevne študije o oralni toksičnosti pri podganah, vključene v dokumentacijo vložnika in brez katere Agencija ne bi mogla oceniti novega živila, v korist poznejšega vložnika.
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.
Zato bi bilo treba dajanje novega živila, odobrenega s to uredbo, na trg Unije omejiti na vložnika za obdobje petih let.
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.
Vendar pa omejevanje odobritve tega novega živila in sklicevanja na 90-dnevno študijo o oralni toksičnosti pri podganah, ki jo vsebuje vložnikova dokumentacija, na izključno uporabo vložnika drugim vložnikom ne preprečuje vložitve vloge za odobritev dajanja na trg istega novega živila, če njihova vloga temelji na zakonito pridobljenih informacijah, ki podpirajo odobritev v skladu s to uredbo.
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.
Ker vir novega živila izvira iz mleka, ki je v Prilogi II k Uredbi (EU) št. 1169/2011 Evropskega parlamenta in Sveta navedeno kot eno od številnih snovi ali proizvodov, ki povzročajo alergije ali preobčutljivost, bi bilo treba živila in prehranska dopolnila, ki vsebujejo bazični izolat beljakovin sirotke iz kravjega mleka, ustrezno označiti v skladu z zahtevami iz člena 21 navedene uredbe.
The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Directive.
Uporabo bazičnega izolata beljakovin sirotke iz kravjega mleka bi bilo treba odobriti brez poseganja v navedeno direktivo.
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.
Uredba (EU) št. 609/2013 Evropskega parlamenta in Sveta določa zahteve glede živil, namenjenih za dojenčke in majhne otroke, živil za posebne zdravstvene namene in popolnih prehranskih nadomestkov za nadzor nad telesno težo.
The use of bovine milk basic whey protein isolate should be authorised without prejudice to that Regulation.
Uporabo bazičnega izolata beljakovin sirotke iz kravjega mleka bi bilo treba odobriti brez poseganja v navedeno uredbo.