natgillin/translations-raw huggingface dataset:
On 18 February 2018, the Authority considered that in elaborating its opinion on pyrroloquinoline quinone disodium salt as a novel food, the data from the bacterial reverse mutation test and from the in vivo micronucleus test studies served as basis to alleviate concerns with respect to the potential genotoxity of pyrroloquinoline quinone disodium salt, and the 14-day oral, the 28-day renal toxicity, and the 90-day oral toxicity studies served as a basis to assess the toxicity profile of pyrroloquinoline quinone disodium salt and to establish the related No Observed Adverse Effect Level (NOAEL).
Agencija je 18. februarja 2018 navedla, da so bile pri pripravi njenega mnenja o pirolokinolin kinon dinatrijevi soli kot novem živilu podatki iz študije o bakterijskem testu povratnih mutacij in študije in vivo preizkusa mikronukleusov podlaga za odpravo pomislekov v zvezi z morebitno genotoksičnostjo pirolokinolin kinon dinatrijeve soli, 14-dnevna študija oralne toksičnosti, 28-dnevna študija renalne toksičnosti in 90-dnevna študija oralne toksičnosti pa so bile podlaga za oceno profila toksičnosti pirolokinolin kinon dinatrijeve soli ter za določitev ravni brez opaženega škodljivega učinka (NOAEL).
Therefore, it is considered that the conclusions on the safety of pyrroloquinoline quinone disodium salt, could not have been reached without the data from the unpublished reports of these studies.
Zato se šteje, da do ugotovitev o varnosti pirolokinolin kinin dinatrijeve soli ne bi bilo mogoče priti brez podatkov iz neobjavljenih poročil o teh študijah.
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to further clarify the justification provided with regard to their proprietary claim over the study reports, which were unpublished at the time the application was made, and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(a)(b) of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 glede poročil o študijah, ki v času vložitve vloge še niso bila objavljena, in svojo zahtevo za izključno pravico sklicevanja na navedene študije, kot je navedeno v členu 26(2)(a)(b) Uredbe (EU) 2015/2283.
The Applicant has also declared that, at the time the application was submitted, they held proprietary or exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies.
Vložnik je prav tako izjavil, da je imel v času vložitve vloge v skladu z nacionalno zakonodajo lastninske ali izključne pravice sklicevanja na študije in da tretje osebe zato niso mogle zakonito dostopati ali uporabljati navedenih študij.
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 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 bacterial reverse mutation test, the in vivo micronucleus test studies, the 14-day oral toxicity, the 28-day renal toxicity, and the 90-day oral toxicity studies contained in the Applicant's file 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, kakor 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 študije o bakterijskem testu povratnih mutacij, študije in vivo preizkusa mikronukleusov, 14-dnevne študije oralne toksičnosti, 28-dnevne študije renalne toksičnosti in 90-dnevne študije oralne toksičnosti, vsebovanih v dokumentaciji vložnika, 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 studies 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 dovoljenja za to novo živilo in sklicevanja na študije, ki jih vsebuje vložnikova dokumentacija, na izključno uporabo vložnika drugim vložnikom ne preprečuje vložitve vloge za dovoljenje za dajanje na trg istega novega živila, če njihova vloga temelji na zakonito pridobljenih informacijah, ki podpirajo odobritev v skladu s to uredbo.
Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing pyrroloquinoline quinone disodium salt should be appropriately labelled.
Ob upoštevanju predvidene uporabe v prehranskih dopolnilih za splošno odraslo populacijo in dejstva, da zahteva za odobritev izključuje nosečnice in doječe matere, bi bilo treba prehranska dopolnila, ki vsebujejo pirolokinolin kinon dinatrijevo sol, ustrezno označiti.
The use of pyrroloquinoline quinone disodium salt should be authorised without prejudice to that Directive.
Uporabo pirolokinolin kinon dinatrijeve soli bi bilo treba odobriti brez poseganja v navedeno direktivo.
Pyrroloquinoline quinone disodium salt 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.
Pirolokinolin kinon dinatrijeva sol, kakor je opredeljena v Prilogi k tej uredbi, se vključi na seznam Unije odobrenih novih živil, vzpostavljen z Izvedbeno uredbo (EU) 2017/2470.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
V obdobju petih let od datuma začetka veljavnosti te uredbe je samo prvotnemu vložniku:
Company: Mitsubishi Gas Chemical Company, Inc.
družba: Mitsubishi Gas Chemical Company, Inc.,
Address: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
naslov: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japonska ;
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Mitsubishi Gas Chemical Company, Inc.
dovoljeno dajati na trg Unije novo živilo iz odstavka 1, razen če poznejši vložnik pridobi dovoljenje za novo živilo brez sklicevanja na podatke, zaščitene v skladu s členom 2 te uredbe, ali s privolitvijo družbe Mitsubishi Gas Chemical Company, Inc.
The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
Vnos na seznamu Unije iz odstavka 1 vključuje pogoje uporabe in zahteve za označevanje, določene v Prilogi k tej uredbi.
The studies 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 proprietary and without which the data protection could not have been authorised, 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 Mitsubishi Gas Chemical Company, Inc.
Študije iz te vloge, na podlagi katerih je Agencija ocenila novo živilo iz člena 1 in pri katerih vložnik zahteva pravno zaščito podatkov, brez katere varstvo podatkov ne bi moglo biti odobreno, se v obdobju petih let od datuma začetka veljavnosti te uredbe brez privolitve družbe Mitsubishi Gas Chemical Company, Inc. ne uporabijo v korist poznejšega vložnika.
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).
Uredba (ES) št. 258/97 Evropskega parlamenta in Sveta z dne 27. januarja 1997 v zvezi z novimi živili in novimi živilskimi sestavinami (UL L 43, 14.2.1997, str. 1).
EFSA Journal 2017; 15(11):5058.
EFSA Journal (2017); 15(11): 5058.
Mitsubishi Gas Chemical Company Inc., 2005b (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2005b (neobjavljeno poročilo).
Mitsubishi Gas Chemical Company Inc., 2008b (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2008b (neobjavljeno poročilo).
Mitsubishi Gas Chemical Company Inc., 2006d (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2006d (neobjavljeno poročilo).
Mitsubishi Gas Chemical Company Inc., 2006c (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2006c (neobjavljeno poročilo).
Mitsubishi Gas Chemical Company Inc., 2005a (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2005a (neobjavljeno poročilo).
Mitsubishi Gas Chemical Company Inc., 2006b (unpublished report).
Mitsubishi Gas Chemical Company Inc., 2006b (neobjavljeno poročilo).
EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of the 83rd Plenary held on 7-8 February 2018 and agreed on 18 February 2018.
Panel za prehrano, nova živila in živilske alergene agencije EFSA, zapisnik 83. plenarnega zasedanja, ki je potekalo 7. in 8. februarja 2018, sprejet 18. februarja 2018.
the following last column is added in Table 1 (Authorised novel foods):
v Tabeli 1 (Odobrena nova živila) se doda naslednji zadnji stolpec:
‘Data Protection’
„Varstvo podatkov“
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
v Tabeli 1 (Odobrena nova živila) se po abecednem vrstnem redu vstavi naslednji vnos:
‘Pyrroloquinoline quinone disodium salt
„pirolokinolin kinon dinatrijeva sol
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Pyrroloquinoline quinone disodium salt”.
Poimenovanje novega živila pri označevanju živil, ki ga vsebujejo, je „pirolokinolin kinon dinatrijeva sol“.
Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:
Prehranska dopolnila, ki vsebujejo pirolokinolin kinon dinatrijevo sol, so označena z naslednjo izjavo:
This food supplement should be consumed by adults only excluding pregnant and lactating women
To prehransko dopolnilo lahko uživajo odrasli, pri čemer so izvzete nosečnice in doječe matere.
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 pirolokinolin kinon dinatrijeva sol na trg v Uniji odobreno le družbi Mitsubishi Gas Chemical Company, Inc., razen če naknadni 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 Mitsubishi Gas Chemical Company, Inc.
Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
Končni datum obdobja varstva podatkov: 2. september 2023.“
During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, 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 Mitsubishi Gas Chemical Company, Inc.
prehranska dopolnila, kot so opredeljena v Direktivi 2002/46/ES, namenjena odrasli populaciji, razen nosečnic in doječih mater
End date of the data protection: 2 september 2023’
20 mg/dan
Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women
v Tabeli 2 (Specifikacije) se po abecednem vrstnem redu vstavi naslednji vnos:
20 mg/day
Odobreno novo živilo
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Specifikacija
Authorised Novel Food
Opredelitev:
Specification
kemijsko ime: dinatrijev 9-karboksi-4,5-diokso-1H-pirolo[5,4-f]kinolin-2,7-dikarboksilat
Definition:
kemijska formula: C14H4N2Na2O8
Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate
št.
CAS No: 122628-50-6
molekulska masa: 374,17 Da
Molecular weight: 374,17 Da
Opis
Description
Pirolokinolin kinon dinatrijeva sol je rdečkastorjav prah, ki se pridobiva z gensko nespremenjeno bakterijo Hyphomicrobium denitrificans, sev CK-275.
Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.
Značilnosti/sestava
Characteristics/Composition
videz: rdečkastorjav prah
Appearance: Reddish-brown powder
čistost: ≥ 99,0 % (suha snov)
Purity: ≥ 99,0 % (dry weight)
UV absorbanca (A322/A259): 0,56 ± 0,03
UV absorbance (A322/A259): 0,56 ± 0,03
UV absorbanca (A233/A259): 0,90 ± 0,09
UV absorbance (A233/A259): 0,90 ± 0,09
vlaga: ≤ 12,0 %
Moisture: ≤ 12,0 %
Ostanki topila:
Residual Solvent
etanol: ≤ 0,05 %
Ethanol: ≤ 0,05 %
Težke kovine
Heavy metals
svinec: < 3 mg/kg
Lead: < 3 mg/kg
arzen: < 2 mg/kg
Arsenic: < 2 mg/kg
Mikrobiološka merila:
Microbiological criteria:
skupno število živih celic: ≤ 300 CFU/g
Total viable cell count: ≤ 300 CFU/g
plesni/kvasovke: ≤ 12 CFU/g
Mould/yeast: ≤ 12 CFU/g
koliformne bakterije: odsotnost v 1 g
Coliforms: absent in 1 g
CFU: kolonijske enote“
CFU: Colony Forming Units’
Odobreno 2. septembra 2018.
Authorised on 2 September 2018.
Ta vključitev temelji na pravno zaščitenih znanstvenih dokazih in znanstvenih podatkih, varovanih v skladu s členom 26 Uredbe (EU) 2015/2283.
Commission Implementing Regulation (EU) 2018/1123
Izvedbena uredba Komisije (EU) 2018/1123
authorising the placing on the market of 1-methylnicotinamide chloride 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 1-metilnikotinamid klorida 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 the Commission Implementing Regulation (EU) 2017/2470 was adopted, which establishes a Union list of authorised novel foods.
V skladu s členom 8 Uredbe (EU) 2015/2283 je bila sprejeta Izvedbena uredba Komisije (EU) 2017/2470, ki vzpostavlja seznam Unije odobrenih novih živil.
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.
Komisija se v skladu s členom 12 Uredbe (EU) 2015/2283 odloči o odobritvi novega živila in dajanju tega živila na trg Unije ter o posodobitvi seznama Unije.
On 18 September 2013, the company Pharmena SA (‘the Applicant’) made a request to the competent authority of the United Kingdom to place synthetic 1-methylnicotinamide chloride on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council.
Družba Pharmena S.A. („vložnik“) je 18. septembra 2013 pristojnemu organu Združenega kraljestva predložila zahtevo za dajanje sintetičnega 1-metilnikotinamid klorida na trg Unije kot novega živila v smislu točke (c) člena 1(2) Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta.
The application requests for 1-methylnicotinamide chloride to be used in food supplements for the general adult population, excluding pregnant and lactating women.
Vloga vsebuje zahtevo za uporabo 1-metilnikotinamid klorida v prehranskih dopolnilih za splošno odraslo populacijo, razen za nosečnice in doječe matere.
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.
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 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 1-methylnicotinamide chloride 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 na trg v Uniji 1-metilnikotinamid klorida kot novega živila je bila državi članici predložena v skladu s členom 4 Uredbe (ES) št. 258/97, vendar izpolnjuje tudi zahteve iz Uredbe (EU) 2015/2283.
On 26 November 2015, the competent authority of the United Kingdom issued its initial assessment report.
Pristojni organ Združenega kraljestva je 26. novembra 2015 izdal poročilo o začetni presoji.
In that report, it came to the conclusion that 1-methylnicotinamide chloride meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.
V navedenem poročilu ugotavlja, da 1-metilnikotinamid klorid izpolnjuje merila za nove živilske sestavine, določena v členu 3(1) Uredbe (ES) št. 258/97.
On 11 December 2015, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 11. decembra 2015 poročilo o začetni presoji 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 and tolerance of 1-methylnicotinamide chloride, and in particular on the effects on consumer health of the long-term intake of 1-MNA, especially when taking into account the intake of niacin from the diet, including food supplements.
Te so v roku 60 dni, ki je določen v prvem pododstavku člena 6(4) Uredbe (ES) št. 258/97, vložile upravičene ugovore glede varnosti in tolerance 1-metilnikotinamid klorida in zlasti učinkov dolgoročnega vnosa 1-metilnikotinamid klorida na zdravje potrošnikov, zlasti ob upoštevanju vnosa niacina s prehrano, med drugim prehranskimi dopolnili.
In view of the objections raised by the other Member States, on 11 August 2016, the Commission consulted the European Food Safety Authority (‘the Authority’) asking it to carry out an additional assessment for 1-methylnicotinamide chloride as novel food ingredient in accordance with Regulation (EC) No 258/97
Glede na ugovore, ki so jih vložile druge države članice, se je Komisija 11. avgusta 2016 posvetovala z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) in jo pozvala k izvedbi dodatne presoje 1-metilnikotinamid klorida kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97.
On 20 September 2017, the Authority adopted ‘Scientific Opinion on the safety of 1-methylnicotinamide chloride as a novel food pursuant to Regulation (EC) No 258/97’.
Agencija je 20. septembra 2017 sprejela znanstveno mnenje o varnosti 1-metilnikotinamid klorida kot novega živila na podlagi Uredbe (ES) št. 258/97 (Scientific Opinion on the safety of 1-methylnicotinamide chloride as a novel food pursuant to Regulation (EC) No 258/97).
This opinion, although elaborated and adopted by EFSA under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Čeprav je agencija EFSA to mnenje pripravila in sprejela na podlagi Uredbe (ES) št. 258/97, je v skladu z zahtevami iz člena 11 Uredbe (EU) 2015/2283.
That opinion gives sufficient grounds to establish that 1-methylnicotinamide chloride in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.
V navedenem mnenju je dovolj dokazov za ugotovitev, da so predlagani načini in ravni uporabe 1-metilnikotinamid klorida, če se uporablja kot sestavina prehranskih dopolnil, skladni s členom 12(1) Uredbe (EU) 2015/2283.
On 25 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, the methods of analysis, an animal toxicity and pharmacokinetic study, a human pharmacokinetic study, an in vitro micronucleus test with human lymphocytes study, a human lipid metabolism study, a 90-day sub chronic oral toxicity study, and a single dose human bioavailability study.
Vložnik je 25. januarja 2018 pri Komisiji vložil zahtevek za varstvo zaščitenih podatkov za več študij, ki so bile predložene v podporo vlogi, namreč analitske metode, študijo toksičnosti za živali in farmakokinetično študijo, farmakokinetično študijo na ljudeh, študijo in vitro preizkusa mikronukleusov na človeških limfocitih, študijo metabolizma lipidov pri ljudeh, 90-dnevno študijo subkronične oralne toksičnosti in študijo biorazpoložljivosti z enkratnim odmerkom pri ljudeh.
On 18 February 2018, the Authority considered that in elaborating its opinion on 1-methylnicotinamide chloride as a novel food, the methods of analysis served as the basis to assess the specifications and the composition of 1-methynicotinamide, the in vitro micronucleus test study with human lymphocytes served as the basis to conclude that there were no concerns with respect to the genotoxicity of 1-methylnicotinamide chloride, and the 90-day oral toxicity study served as the basis to establish a reference point and to assess whether the margin of exposure in relation to the proposed maximum intake of 1-methylnicotinamide chloride by humans is sufficient.
Agencija je 18. februarja 2018 navedla, da so bile pri pripravi njenega mnenja o 1-metilnikotinamid kloridu kot novem živilu analitske metode podlaga za oceno specifikacij in sestave 1-metilnikotinamida, študija in vitro preizkusa mikronukleusov na človeških limfocitih podlaga za ugotovitev, da ni nobenih pomislekov glede genotoksičnosti 1-metilnikotinamid klorida, 90-dnevna študija oralne toksičnosti pa je bila uporabljena kot podlaga za določitev referenčne točke in za oceno, ali stopnja izpostavljenosti v razmerju do predlaganega največjega vnosa 1-metilnikotinamid klorida pri ljudeh zadostuje.
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 studies, which were unpublished at the time the application was submitted, and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(a)(b) 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 glede študij, ki v času vložitve vloge še niso bile objavljene, in svojo zahtevo za izključno pravico sklicevanja na navedene študije, kot je navedeno v členu 26(2)(a) in (b) Uredbe (EU) 2015/2283.
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 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.