natgillin/translations-raw huggingface dataset:
In addition, Article 2(2) of Regulation (EU) 2016/429 provides that that Regulation is to apply to transmissible diseases, including zoonosis, without prejudice to rules laid down in Decision No 1082/2013/EU of the European Parliament and of the Council, Regulation (EC) No 999/2001 of the European Parliament and of the Council, Directive 2003/99/EC of the European Parliament and of the Council and Regulation (EC) No 2160/2003 of the European Parliament and of the Council.
, zarazna pleuropneumonija koza, epididimitis ovaca (Brucella ovis), infekcija s Burkholderia mallei (maleus), infekcija virusnim arteritisom konja, infekciozna anemija kopitara, durina, kontagiozni metritis kobila, encefalomijelitis konja (istočni i zapadni), infekcija virusom bolesti Aujeszkoga, infekcija virusom reproduktivnog i respiratornog sindroma svinja, ptičja mikoplazmoza (Mycoplasma gallisepticum i M. meleagridis), infekcija virusima nisko patogene influence ptica, klamidioza ptica, zaraza s Varroa spp. (varooza)EFSA Journal 2017.; 15(10):4997.
As the diseases covered by the rules laid down in those acts, namely listeriosis, salmonellosis (zoonotic salmonella), trichinellosis, verotoxigenic E. coli and transmissible spongiform encephalopathies (TSE) are already covered by sector-specify rules, they should therefore be removed from the list set out in Annex II to Regulation (EU) 2016/429.
, zaraza s Aethina tumida (mali kornjaš košnice), američka gnjiloća, zaraza s Tropilaelaps spp.EFSA Journal 2013.; 11(3):3128.
The list of diseases in Annex II to Regulation (EU) 2016/429 should therefore be amended accordingly.
i infekcija s Batrachochytrium salamandrivorans ispunjavaju zahtjeve utvrđene u članku 5. stavku 3.
Regulation (EU) 2016/429 should therefore be amended.
Uredbe (EU) 2016/429.
As Regulation (EU) 2016/429 applies with effect from 21 April 2021, the amendments made to it by this Regulation should also apply from that date,
Osim toga, člankom 2. stavkom 2.
HAS ADOPTED THIS REGULATION:
Uredbe (EU) 2016/429 predviđa se da se ta uredba primjenjuje na prenosive bolesti, uključujući zoonoze, ne dovodeći u pitanje pravila utvrđena Odlukom br. 1082/2013/EU Europskog parlamenta i Vijeća, Uredbom (EZ) br. 999/2001 Europskog parlamenta i Vijeća, Direktivom 2003/99/EZ Europskog parlamenta i Vijeća i Uredbom (EZ) br. 2160/2003 Europskog parlamenta i Vijeća.
Article 1
Budući da su bolesti obuhvaćene pravilima utvrđenima u tim aktima, odnosno listerioza, salmoneloza (zoonotska salmonela), trihineloza, verotoksična E. coli i transmisivne spongiformne encefalopatije (TSE), već obuhvaćene sektorskim pravilima, trebalo bi ih ukloniti s popisa iz Priloga II.
Annex II to Regulation (EU) 2016/429 is replaced by the text set out in the Annex to this Regulation.
Uredbi (EU) 2016/429.
Article 2
Popis bolesti iz Priloga II.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Uredbi (EU) 2016/429 trebalo bi stoga na odgovarajući način izmijeniti.
It shall apply from 21 April 2021.
Uredbu (EU) 2016/429 trebalo bi stoga izmijeniti.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Budući da se Uredba (EU) 2016/429 primjenjuje od 21. travnja 2021., njezine izmjene na temelju ove Uredbe također bi se trebale primjenjivati od tog datuma,
Done at Brussels, 25 July 2018.
DONIJELA JE OVU UREDBU:
OJ L 84, 31.3.2016, p. 1.
Uredbi (EU) 2016/429 zamjenjuje se tekstom iz Priloga ovoj Uredbi.
EFSA Journal 2017;15(7):4783.
Članak 2.
EFSA Journal 2017;15(7):4892.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
EFSA Journal 2017;15(8):4956.
Primjenjuje se od 21. travnja 2021.
EFSA Journal 2017;15(8):4950.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
EFSA Journal 2017;15(10):4997.
Sastavljeno u Bruxellesu 25. srpnja 2018.
EFSA Journal 2017;15(7):4907.
Za Komisiju
EFSA Journal 2012;10(4):2631.
Predsjednik
EFSA Journal 2011;9(10):2387.
SL L 84, 31.3.2016., str. 1.
EFSA Journal 2017;15(7):4890.
EFSA Journal 2017.; 15(7):4783.
EFSA Journal 2017;15(7):4960.
EFSA Journal 2017.; 15(7):4892.
EFSA Journal 2017;15(7):4948.
EFSA Journal 2017.; 15(8):4956.
EFSA Journal 2017;15(8):4955.
EFSA Journal 2017.; 15(8):4950.
EFSA Journal 2010; 8(5):1595.
EFSA Journal 2017.; 15(10):4997.
EFSA Journal 2017;15(7):4947.
EFSA Journal 2017.; 15(7):4907.
EFSA Journal 2017;15(8):4952.
EFSA Journal 2012.; 10(4):2631.
EFSA Journal 2017;15(10):4990.
EFSA Journal 2011.; 9(10):2387.
EFSA Journal 2017;15(10):4992.
EFSA Journal 2017.; 15(7):4890.
EFSA Journal 2017;15(10):4996.
EFSA Journal 2017.; 15(7):4960.
EFSA Journal 2017;15(10):4994.
EFSA Journal 2017.; 15(7):4948.
EFSA Journal 2017;15(7):4946.
EFSA Journal 2017.; 15(8):4955.
EFSA Journal 2017;15(7):4888.
EFSA Journal 2010.; 8(5):1595.
EFSA Journal 2017;15(7):4949.
EFSA Journal 2017.; 15(7):4947.
EFSA Journal 2017;15(8):4953.
EFSA Journal 2017.; 15(8):4952.
EFSA Journal 2017;15(7):4891.
EFSA Journal 2017.; 15(10):4990.
Report of the Scientific Committee on Animal Health and Animal Welfare adopted on 16 April 2002, https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scah_out73_en.pdf
EFSA Journal 2017.; 15(10):4992.
EFSA Journal 2013;11(3):3128.
EFSA Journal 2017.; 15(10):4996.
EFSA Journal 2017;15(11):5071.
EFSA Journal 2017.; 15(10):4994.
Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
EFSA Journal 2017.; 15(7):4946.
Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
EFSA Journal 2017.; 15(7):4888.
Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31).
EFSA Journal 2017.; 15(7):4949.
Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).
EFSA Journal 2017.; 15(8):4953.
ANNEX
EFSA Journal 2017.; 15(7):4891.
ANNEX II
Izvješće Znanstvenog odbora za zdravlje i dobrobit životinja doneseno 16. travnja 2002., https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scah_out73_en.pdf
LIST OF ANIMAL DISEASES
EFSA Journal 2013.; 11(3):3128.
Infection with rinderpest virus
EFSA Journal 2017.; 15(11):5071.
Infection with Rift Valley fever virus
Odluka br. 1082/2013/EU Europskog parlamenta i Vijeća od 22. listopada 2013. o ozbiljnim prekograničnim prijetnjama zdravlju i o stavljanju izvan snage Odluke br. 2119/98/EZ (SL L 293, 5.11.2013., str. 1.).
Infection with Brucella abortus, B. melitensis and B. suis
Uredba (EZ) br. 999/2001 Europskog parlamenta i Vijeća od 22. svibnja 2001. o utvrđivanju pravila za sprečavanje, kontrolu i iskorjenjivanje određenih transmisivnih spongiformnih encefalopatija (SL L 147, 31.5.2001., str. 1.).
Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis)
Direktiva 2003/99/EZ Europskog parlamenta i Vijeća od 17. studenoga 2003. o praćenju zoonoza i uzročnika zoonoza, o izmjeni Odluke Vijeća 90/424/EEZ i o stavljanju izvan snage Direktive Vijeća 92/117/EEZ (SL L 325, 12.12.2003., str. 31.).
Infection with rabies virus
Uredba (EZ) br. 2160/2003 Europskog parlamenta i Vijeća od 17. studenoga 2003. o kontroli salmonele i drugih određenih uzročnika zoonoza koji se prenose hranom (SL L 325, 12.12.2003., str. 1.)
Infection with bluetongue virus (serotypes 1-24)
PRILOG
Infestation with Echinococcus multilocularis
PRILOG II.
Infection with epizootic haemorrhagic disease virus
POPIS BOLESTI ŽIVOTINJA
Anthrax
Infekcija virusom goveđe kuge
Surra (Trypanosoma evansi)
Infekcija virusom groznice Riftske doline (Rift Valley)
Ebola virus disease
Infekcija s Brucella abortus, B. melitensis i B.suis
Paratuberculosis
Infekcija kompleksom Mycobacterium tuberculosis (M. bovis, M. caprae i M. tuberculosis)
Japanese encephalitis
Infekcija virusom bjesnoće
West Nile fever
Infekcija virusom bolesti plavog jezika (serotipovi 1–24)
Q fever
Zaraza s Echinococcus multilocularis
Infection with lumpy skin disease virus
Infekcija virusom epizootske hemoragijske bolesti
Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia)
Bedrenica
Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
Sura (Trypanosoma evansi)
Bovine viral diarrhoea
Bolest virusa ebole
Bovine genital campylobacteriosis
Paratuberkuloza
Trichomonosis
Japanski encefalitis
Enzootic bovine leukosis
Groznica zapadnog Nila
Sheep pox and goat pox
Q groznica
Infection with peste des petits ruminants virus
Infekcija virusom bolesti kvrgave kože
Contagious caprine pleuropneumonia
Infekcija s Mycoplasma mycoides podvrsta mycoides, mala kolonija (zarazna pleuropneumonija goveda)
Ovine epididymitis (Brucella ovis)
Zarazni rinotraheitis goveda/zarazni pustularni vulvovaginitis
Infection with Burkholderia mallei (Glanders)
Virusni proljev goveda
Infection with equine arteritis virus
Goveđa genitalna kampilobakterioza
Equine infectious anaemia
Trihomonijaza
Dourine
Enzootska leukoza goveda
Venezuelan equine encephalomyelitis
Ovčje i kozje boginje
Contagious equine metritis
Infekcija virusom kuge malih preživača
Equine encephalomyelitis (Eastern and Western)
Zarazna pleuropneumonija koza
Infection with Aujeszky's disease virus
Epididimitis ovaca (Brucella ovis)
Infection with porcine reproductive and respiratory syndrome virus
Infekcija s Burkholderia mallei (maleus)
Infection with Newcastle disease virus
Infekcija virusnim arteritisom konja
Avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis)
Infekciozna anemija kopitara
Infection with Salmonella Pullorum, S. Gallinarum and S. arizonae
Durina
Infection with low pathogenic avian influenza viruses
Venezuelski encefalomijelitis konja
Avian chlamydiosis
Kontagiozni metritis kobila
Infestation with Aethina tumida (Small hive beetle)
Infekcija virusom reproduktivnog i respiratornog sindroma svinja
American foulbrood
Infekcija virusom newcastelske bolesti
Infestation with Tropilaelaps spp.
Ptičja mikoplazmoza (Mycoplasma gallisepticum i M. meleagridis)
Infection with Batrachochytrium salamandrivorans
Infekcija s Salmonella Pullorum, S. Gallinarum i S. arizonae
Epizootic haematopoietic necrosis
Infekcija virusima nisko patogene influence ptica
Viral haemorrhagic septicaemia
Klamidioza ptica
Infectious haematopoietic necrosis
Zaraza s Aethina tumida (mali kornjaš košnice)
Infection with highly polymorphic region (HPR) deleted infectious salmon anaemia virus
Američka gnjiloća
Koi herpes virus disease
Zaraza s Tropilaelaps spp.
Infection with Mikrocytos mackini
Infekcija s Batrachochytrium salamandrivorans
Infection with Perkinsus marinus
Epizootska hematopoetska nekroza
Infection with Bonamia ostreae
Virusna hemoragijska septikemija
Infection with Bonamia exitiosa
Zarazna hematopoetska nekroza
Infection with Marteilia refringens
Infekcija virusom anemije lososa s uklonjenim genotipom HPR (visoko polimorfno područje)
Infection with Taura syndrome virus
Bolest koju uzrokuje virus koi herpes
Infection with yellow head virus
Infekcija s Mikrocytos mackini
Infection with white spot syndrome virus
Infekcija s Perkinsus marinus
The results of the scientific assessments by EFSA were inconclusive for certain diseases such as surra (Trypanosoma evansi), enzootic bovine leukosis, Venezuelan equine encephalomyelitis, infestation with Varroa spp.
Infekcija s Bonamia ostreae
(Varroosis) and Koi herpes virus disease.
Infekcija s Bonamia exitiosa
https://ec.europa.eu/food/animals/health/expert_group_en
Infekcija virusom žute glave rakova
Commission Implementing Regulation (EU) 2018/1630
Provedbena uredba Komisije (EU) 2018/1630
Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia's application to register the name ‘Lička janjetina’ was published in the Official Journal of the European Union.
U skladu s člankom 50. stavkom 2. točkom (a) Uredbe (EU) br. 1151/2012, zahtjev Hrvatske za upis naziva „Lička janjetina” u registar objavljen je u Službenom listu Europske unije.
As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Lička janjetina’ should therefore be entered in the register,
Budući da Komisiji nije dostavljen ni jedan prigovor u smislu članka 51.
HAS ADOPTED THIS REGULATION:
Uredbe (EU) br. 1151/2012, naziv „Lička janjetina” potrebno je upisati u registar,
The name ‘Lička janjetina’ (PGI) is hereby entered in the register.
Članak 1.
The name specified in the first paragraph denotes a product in Class 1.1.
Naziv „Lička janjetina” (ZOZP) upisuje se u registar.
Fresh meat (and offal), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014.
Naziv iz prvog stavka odnosi se na proizvod iz razreda 1.1.
Article 2
Svježe meso (i nusproizvodi klanja) iz Priloga XI.
Done at Brussels, 24 October 2018.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
On behalf of the President,
Sastavljeno u Bruxellesu 24. listopada 2018.
OJ C 153, 2.5.2018, p. 11.
Član Komisije
Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
SL L 343, 14.12.2012., str. 1.
authorising the placing on the market of cranberry extract powder 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 ekstrakta brusnice u prahu kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001, and in particular Article 12 thereof,
uzimajući u obzir Uredbu (EU) 2015/2283 Europskog parlamenta i Vijeća od 25. studenoga 2015. o novoj hrani, o izmjeni Uredbe (EU) br. 1169/2011 Europskog parlamenta i Vijeća i o stavljanju izvan snage Uredbe (EZ) br. 258/97 i Uredbe Komisije (EZ) br. 1852/2001, a posebno njezin članak 12.,
Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
Uredbom (EU) 2015/2283 predviđeno je da se samo nova hrana koja je odobrena i uvrštena na popis Unije može stavljati na tržište u Uniji.
On 20 September 2011, the company Ocean Spray Cranberries Inc. (‘the Applicant’) made a request to the competent authority of France to place cranberry extract powder on the Union market as a novel food within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council.
U skladu s člankom 12.
The application requested for cranberry extract powder to be used in fruit-flavoured beverages, isotonic beverages, tea beverages, vitamin enhanced waters, yogurts and yogurt drinks.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije te ažuriranju popisa Unije.
On 11 December 2014, the competent authority of France issued its initial assessment report.
Društvo Ocean Spray Cranberries Inc. („podnositelj zahtjeva”) podnijelo je 20. rujna 2011. nadležnom tijelu Francuske zahtjev za stavljanje na tržište Unije ekstrakta brusnice u prahu kao nove hrane u smislu članka 1. stavka 2. točke (c) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
In that report it came to the conclusion that cranberry extract powder meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.
U zahtjevu se traži da se odobri upotreba ekstrakta borovnice u prahu u napicima s voćnom aromom, izotoničnim napicima, čajnim napicima, vodama s dodatkom vitamina, jogurtima i pićima na bazi jogurta.
In the same report, the competent authority of France also expressed concerns regarding possible nutritional risks associated with the overconsumption of polyphenols for children between one and three years of age resulting from the intake of polyphenols from the novel food, and from other sources of polyphenols in children's diet.
Nadležno tijelo Francuske izdalo je 11. prosinca 2014. izvješće o početnoj ocjeni.
On 16 January 2015, the Commission forwarded the initial assessment report to the other Member States.
U tom je izvješću zaključilo da ekstrakt brusnice u prahu ispunjava kriterije za novi sastojak hrane utvrđene u članku 3. stavku 1.
Reasoned objections were raised by the 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 insufficient data excluding the risk for young children aged between one and three years, incomplete specification of the novel food, and lack of information on the protein content needed to exclude allergy risk.
Uredbe (EZ) br. 258/97.
In view of the initial assessment report issued by the competent authority of France and the objections raised by some Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 20 April 2016, asking it to carry out an additional assessment for cranberry extract powder as a novel food in accordance with Regulation (EC) No 258/97.
Osim toga, nadležno tijelo Francuske izrazilo je u tom izvješću zabrinutost u pogledu mogućih prehrambenih rizika povezanih s prekomjernom konzumacijom polifenola za djecu u dobi od jedne do tri godine zbog unosa polifenola iz nove hrane i drugih izvora polifenola u dječjoj prehrani.
In contacts with the Authority the Applicant has declared that the novel food is not intended to be marketed to infants, toddlers and children of below 19 years of age.
Komisija je 16. siječnja 2015. izvješće o početnoj ocjeni proslijedila ostalim državama članicama.
On 4 April 2017, the Authority adopted a ‘Scientific Opinion on the safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97’ in which it concluded that cranberry extract is safe for the uses communicated by the Applicant.
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 nedostatka podataka kojima bi se isključio rizik za malu djecu u dobi od jedne do tri godine, nepotpune specifikacije nove hrane i nedostatka informacija o sadržaju bjelančevina koje su potrebne da se isključi rizik od alergije.
That opinion, although elaborated and adopted by the Authority under Regulation (EC) No 258/97, is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
S obzirom na izvješće o početnoj ocjeni koje je izdalo nadležno tijelo Francuske i prigovore koje su uložile neke države članice, Komisija je 20. travnja 2016. zatražila od Europske agencije za sigurnost hrane („Agencija”) da provede dodatnu ocjenu ekstrakta brusnice u prahu kao nove hrane u skladu s Uredbom (EZ) br. 258/97.
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.
Podnositelj zahtjeva je u kontaktima s Agencijom izjavio da nova hrana nije namijenjena stavljanju na tržište za novorođenčad, malu djecu i djecu mlađu od 19 godina.
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.
Agencija je 4. travnja 2017. donijela „Znanstveno mišljenje o sigurnosti ekstrakta brusnice u prahu kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97”, u kojem je zaključila da je ekstrakt borovnice siguran za upotrebe koje je naveo podnositelj zahtjeva.
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.
Iako je Agencija to mišljenje izradila i donijela na temelju Uredbe (EZ) br. 258/97, ono je u skladu sa zahtjevima iz članka 11.
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.
Uredbe (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.
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.
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.
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.
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 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.
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.
U skladu s člankom 35. stavkom 1.