natgillin/translations-raw huggingface dataset:
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.
Znanstveni odbor EFSA-e za dijetetske proizvode, prehranu i alergije, zapisnik s 83. plenarne sjednice održane 7.. i 8. veljače 2018. i odobren 18. veljače 2018.
the following last column is added in Table 1 (Authorised novel foods):
Sljedeći zadnji stupac umeće se u tablicu 1. (Odobrena nova hrana):
‘Data Protection’
„Zaštita podataka”
‘Pyrroloquinoline quinone disodium salt
„Dinatrijeva sol pirolokinolin kinona
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Pyrroloquinoline quinone disodium salt”.
Pri označivanju hrane koja sadržava novu hranu navodi se „dinatrijeva sol pirolokinolin kinona”.
Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:
Na dodacima prehrani koji sadržavaju dinatrijevu sol pirolokinolin kinona navodi se sljedeća izjava:
This food supplement should be consumed by adults only excluding pregnant and lactating women
Ovaj dodatak prehrani smiju konzumirati samo odrasli, isključujući trudnice i dojilje
Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
Podnositelj zahtjeva: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
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.
Tijekom razdoblja zaštite podataka stavljanje na tržište Unije nove hrane „dinatrijeva sol pirolokinolin kinona” odobrava se isključivo podnositelju zahtjeva Mitsubishi Gas Chemical Company, Inc., osim ako budući podnositelj zahtjeva dobije odobrenje za 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 Mitsubishi Gas Chemical Company, Inc.
End date of the data protection: 2 september 2023’
Datum završetka zaštite podataka: 2. rujna 2023.”
Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni općoj populaciji, isključujući trudnice i dojilje
20 mg/day
20 mg dnevno
Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate
Kemijski naziv: dinatrijev 9-karboksi-4,5-diokso-1H-pirolo[5,4-f]kinolin-2,7-dikarboksilat
Chemical formula: C14H4N2Na2O8
Kemijska formula: C14H4N2Na2O8
CAS No: 122628-50-6
CAS br.: 122628-50-6
Molecular weight: 374,17 Da
Molekulska masa: 374,17 Da
Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.
Dinatrijeva sol pirolokinolin kinona je crvenkastosmeđi prah proizveden od negenetski modificirane bakterije Hyphomicrobium denitrificans soj CK-275.
Appearance: Reddish-brown powder
Izgled: crvenkastosmeđi prah
Purity: ≥ 99,0 % (dry weight)
Čistoća: ≥ 99,0 % (suhe tvari)
UV absorbance (A322/A259): 0,56 ± 0,03
Apsorpcija UV svjetla (A322/A259): 0,56 ± 0,03
UV absorbance (A233/A259): 0,90 ± 0,09
Apsorpcija UV svjetla (A233/A259): 0,90 ± 0,09
Moisture: ≤ 12,0 %
Vlaga: ≤ 12,0 %
Residual Solvent
Ostaci otapala
Ethanol: ≤ 0,05 %
Etanol: ≤ 0,05 %
Lead: < 3 mg/kg
Olovo: < 3 mg/kg
Arsenic: < 2 mg/kg
Arsen: < 2 mg/kg
Total viable cell count: ≤ 300 CFU/g
Ukupan broj živih stanica: ≤ 300 CFU/g
Mould/yeast: ≤ 12 CFU/g
Plijesan/kvasac: ≤ 12 CFU/g
Coliforms: absent in 1 g
Koliformi: nije prisutno u 1 g
CFU: Colony Forming Units’
CFU: jedinice koje tvore kolonije”
Authorised on 2 September 2018.
Odobreno 2. rujna 2018.
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Ovo uvrštenje temelji se na vlasnički zaštićenim znanstvenim dokazima i znanstvenim podacima zaštićenima u skladu s člankom 26. Uredbe (EU) 2015/2283.
Commission Implementing Regulation (EU) 2018/1123
Provedbena 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 odobravanju stavljanja na tržište 1-metilnikotinamid klorida kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
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.
Društvo Pharmena S.A. („podnositelj zahtjeva”) podnijelo je 18. rujna 2013. nadležnom tijelu Ujedinjene Kraljevine zahtjev za stavljanje na tržište Unije sintetskog 1-metilnikotinamid klorida kao novog sastojka hrane u smislu članka 1. stavka 2. točke (c) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
The application requests for 1-methylnicotinamide chloride to be used in food supplements for the general adult population, excluding pregnant and lactating women.
Zahtjevom se tražilo odobrenje uporabe 1-metilnikotinamid klorida u dodacima prehrani za opću populaciju odraslih, osim trudnica i dojilja.
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.
U skladu s člankom 35. stavkom 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 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 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.
Zahtjev za stavljanje na tržište Unije 1-metilnikotinamid klorida 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 26 November 2015, the competent authority of the United Kingdom issued its initial assessment report.
Nadležno tijelo Ujedinjene Kraljevine izdalo je 26. studenoga 2015. izvješće o početnoj procjeni.
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.
U tom je izvješću zaključeno da 1-metilnikotinamid klorid ispunjava kriterije za novi sastojak hrane utvrđene člankom 3. stavkom 1. Uredbe (EZ) br. 258/97.
On 11 December 2015, the Commission forwarded the initial assessment report to the other Member States.
Komisija je 11. prosinca 2015. 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 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.
Ostale države članice uložile su obrazložene prigovore u roku od 60 dana propisanom člankom 6. stavkom 4. prvim podstavkom Uredbe (EZ) br. 258/97 s obzirom na sigurnost i podnošljivost 1-metilnikotinamid klorida, a posebno s obzirom na učinke dugoročnog unosa 1-metilnikotinamid klorida na zdravlje potrošača, osobito uzimajući u obzir unos niacina u hrani, uključujući dodatke prehrani.
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
S obzirom na prigovore koje su uložile ostale države članice, Komisija je 11. kolovoza 2016. zatražila od Europske agencije za sigurnost hrane (EFSA) da provede dodatnu procjenu 1-metilnikotinamid klorida kao novog sastojka hrane u skladu s Uredbom (EZ) br. 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. rujna 2017. donijela „Znanstveno mišljenje o sigurnosti 1-metilnikotinamid klorida kao nove hrane u skladu s Uredbom (EZ) br. 258/97”.
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.
U mišljenju se iznosi dovoljno informacija na temelju kojih se može utvrditi da je 1-metilnikotinamid klorid u predloženim uporabama i razinama uporabe, ako se upotrebljava kao sastojak u dodacima prehrani, u skladu s člankom 12. stavkom 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.
Podnositelj zahtjeva Komisiji je 25. siječnja 2018. podnio zahtjev za zaštitu vlasničkih podataka povezanih s nizom studija provedenih u potporu zahtjevu, i to metodama analize, studijom toksičnosti i farmakokinetičkom studijom provedenom na životinjama, farmakokinetičkom studijom provedenom na ljudima, studijom o mikronukleus testu in vitro ljudskih limfocita, studijom o ljudskom metabolizmu lipida, 90-dnevnom studijom subkronične oralne toksičnosti te studijom o bioraspoloživosti pojedinačne doze kod ljudi.
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. veljače 2018. navela da su u obrazloženju njezina mišljenja o 1-metilnikotinamid kloridu kao novoj hrani, metode analize služile kao osnova za ocjenu specifikacija i sastava 1-metilnikotinamid klorida; studija o mikronukleus testu in vitro ljudskih limfocita služila je kao osnova za zaključak da ne postoji zabrinutost u pogledu genotoksičnosti 1-metilnikotinamid klorida; i 90-dnevna studija oralne toksičnosti služila je kao osnova za utvrđivanje referentne točke i ocjenu dostatne granice izloženosti u odnosu na predloženu najveću razinu unosa 1-metilnikotinamid klorida kod ljudi.
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.
Nakon primitka mišljenja Agencije Komisija je zatražila od podnositelja zahtjeva da dodatno pojasni obrazloženje s obzirom na njegov zahtjev za zaštitu vlasničkih podataka iz izvješća o studijama, koje u trenutku podnošenja zahtjeva nisu bile objavljene, kao i da pojasni zahtjev za isključivo pravo upućivanja na te studije, kako je navedeno u članku 26. stavku 2. točkama (a) i (b) Uredbe (EU) 2015/2283.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the methods of analysis of 1-methylnicotinamide chloride, the in vitro micronucleus test with human lymphocytes study, and the 90-day sub chronic oral toxicity study 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.
U skladu s tim, kako je predviđeno člankom 26. stavkom 2. Uredbe (EU) 2015/2283, Agencija ne bi smjela upotrijebiti metode analize 1-metilnikotinamid klorida, studiju o mikronukleus testu in vitro ljudskih limfocita te 90-dnevnu studiju subkronične oralne toksičnosti iz dosjea podnositelja zahtjeva u korist budućeg podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe.
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 available outside the Applicant's file supporting the authorisation under this Regulation.
Međutim, ograničenje odobrenja te nove hrane i upućivanje na studije iz dosjea podnositelja zahtjeva isključivo za potrebe podnositelja zahtjeva ne sprečava ostale podnositelje zahtjeva da zatraže odobrenje za stavljanje na tržište te iste nove hrane, uz uvjet da se njihov zahtjev temelji na zakonito pribavljenim informacijama dostupnima izvan dosjea podnositelja zahtjeva kojima se podupire odobrenje u skladu s ovom Uredbom.
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 1-methylnicotinamide chloride should be appropriately labelled.
Uzimajući u obzir predviđenu uporabu u dodacima prehrani za opću populaciju odraslih i činjenicu da zahtjev za odobrenje isključuje trudnice i dojilje, dodatke prehrani koji sadržavaju 1-metilnikotinamid klorid trebalo bi na odgovarajući način označiti.
The use of 1-methylnicotinamide chloride should be authorised without prejudice to that Directive.
Uporabu 1-metilnikotinamid klorida trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
1-methylnicotinamide chloride 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.
1-metilnikotinamid klorid, kako je navedeno u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen Provedbenom uredbom (EU) 2017/2470.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
U razdoblju od pet godina od dana stupanja na snagu ove Uredbe odobrava se isključivo prvotnom podnositelju zahtjeva:
Wolczanska 178, 90 530 Lodz, Poland
adresa: ul. Wolczanska 178, 90 530 Lodz, Poljska ;
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 Pharmena SA.
stavljanje na tržište Unije nove hrane iz stavka 1., osim ako budući podnositelj zahtjeva dobije odobrenje za novu hranu bez upućivanja na podatke zaštićene u skladu s člankom 2. ove Uredbe ili uz suglasnost društva Pharmena S.A.
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 Pharmena SA.
Studije iz dosjea podnositelja zahtjeva na temelju kojih je Agencija provela ocjenu nove hrane iz članka 1., na koje podnositelj zahtjeva polaže vlasnička prava i bez kojih zaštita podataka ne bi bila odobrena, ne smiju se upotrijebiti u korist budućih podnositelja zahtjeva u razdoblju od pet godina od datuma stupanja na snagu ove Uredbe bez suglasnosti društva Pharmena S.A.
EFSA Journal 2017; 15(10):5001.
EFSA Journal 2017.; 15(10):5001.
Unpublished internal company report.
Neobjavljeno interno izvješće društva.
Przybyła M., 2013, unpublished report.
Przybyła M., 2013., neobjavljeno izvješće.
Proskin, H.M., 2008, unpublished report.
Proskin, H. M., 2008., neobjavljeno izvješće.
Stepnik M., 2012, unpublished report.
Stepnik M., 2012., neobjavljeno izvješće.
Cossette M., 2009, unpublished report.
Cossette M., 2009., neobjavljeno izvješće.
Ford J.A., 2014, unpublished study.
Ford J. A., 2014., neobjavljena studija.
Dessouki E., 2013, unpublished study.
Dessouki E., 2013., neobjavljena studija.
‘1-Methylnicotinamide chloride
„1-metilnikotinamid klorid
The designation of the novel food on the labelling of the foodstuffs containing it shall be “1- Methylnicotinamide chloride”.
Pri označivanju hrane koja sadržava novu hranu navodi se „1-metilnikotinamid klorid”.
Food supplements containing 1-Methylnicotinamide shall bear the following statement:
Na dodacima prehrani koji sadržavaju 1-metilnikotinamid klorid navodi se sljedeća izjava:
Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland
Podnositelj zahtjeva: Pharmena S.A., Wolczanska 178, 90 530 Lodz, Poljska
During the period of data protection the novel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. 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 Pharmena S.A.
Tijekom razdoblja zaštite podataka stavljanje na tržište Unije nove hrane 1-metilnikotinamid klorid odobrava se isključivo podnositelju zahtjeva Pharmena S.A., osim ako budući podnositelj zahtjeva dobije odobrenje za 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 Pharmena S.A.
End date of the data protection: 2 September 2023’.
Datum završetka zaštite podataka: 2. rujna 2023.”
Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni općoj populaciji, isključujući trudnice i dojilje
58 mg/day
58 mg dnevno
Chemical name: 3-carbamoyl-1-methyl-pyridinium chloride
Kemijski naziv: 3-karbamoil-1-metil-piridinij klorid
Chemical formula: C7H9N2OCl
Kemijska formula: C7H9N2OCl
CAS No: 1005-24-9
CAS br.: 1005-24-9
Molecular weight: 172,61 Da
Molekulska masa: 172,61 Da
1-Methylnicotinamide chloride is white or off-white, crystalline solid produced by a chemical synthesis process.
1-metilnikotinamid klorid je bijela ili sivobijela kristalna krutina koja se proizvodi postupkom kemijske sinteze.
Appearance: White – off-white, crystalline solid
Izgled: bijela ili sivobijela kristalna krutina
Purity: ≥ 98,5 %
Čistoća: ≥ 98,5 %
Trigonelline: ≤ 0,05 %
Trigonelin: ≤ 0,05 %
Nicotinic Acid: ≤ 0,10 %
Nikotinska kiselina: ≤ 0,10 %
Nicotinamide: ≤ 0,10 %
Nikotinamid: ≤ 0,10 %
Largest unknown impurity: ≤ 0,05 %
Najveća nepoznata nečistoća: ≤ 0,05 %
Sum of unknown impurities: ≤ 0,20 %
Zbroj nepoznatih nečistoća: ≤ 0,20 %
Sum of all impurities: ≤ 0,50 %
Zbroj svih nečistoća: ≤ 0,50 %
Solubility: soluble in water and methanol.
Topljivost: topljivo u vodi i metanolu.
Practically insoluble in 2-propanol and dichloromethane
Praktički netopljivo u 2-propanolu i diklorometanu
Loss on drying: ≤ 1,0 %
Gubitak pri sušenju: ≤ 1,0 %
Residual Solvents and Heavy Metals
Ostaci otapala i teški metali
Methanol: ≤ 0,3 %
Metanol: ≤ 0,3 %
Heavy metals: ≤ 0,002 %
Teški metali: ≤ 0,002 %
Mould/yeast: ≤ 10 CFU/g
Plijesan/kvasac: ≤ 10 CFU/g
Enterobacteriaceae: absence in 1 g
Enterobacteriaceae: nije prisutno u 1 g
Pseudomonas aeruginosa: absence in 1 g
Pseudomonas aeruginosa: nije prisutno u 1 g
Staphylococcus aureus: absent in 1 g
Staphylococcus aureus: nije prisutno u 1 g
Company: Pharmena SA Address: ul.
društvu: Pharmena S.A.,
Commission Implementing Regulation (EU) 2018/1124
Provedbena uredba Komisije (EU) 2018/1124
On 7 August 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply.
Odbor za sankcije Vijeća sigurnosti Ujedinjenih naroda odlučio je 7. kolovoza 2018. izbrisati jedan unos s popisa osoba ili subjekata na koje bi se trebalo primjenjivati zamrzavanje sredstava i ekonomskih izvora.
DIRECTORATE GENERAL OF GEOLOGICAL SURVEY AND MINERAL INVESTIGATION.
DIRECTORATE GENERAL OF GEOLOGICAL SURVEY AND MINERAL INVESTIGATION. Adresa: P.O.
Address: P.O. Box 986, Alwiya, Al Sadoon Park Area, Baghdad, Iraq
Box 986, Alwiya, Al Sadoon Park Area, Baghdad, Iraq
Commission Delegated Regulation (EU) 2018/1127
Delegirana uredba Komisije (EU) 2018/1127
Having regard to Regulation (EU) No 1304/2013 of the European Parliament and of the Council on the European Social Fund and repealing Council Regulation (EC) No 1081/2006, and in particular Article 14(1) thereof,
uzimajući u obzir Uredbu (EU) br. 1304/2013 Europskog parlamenta i Vijeća o Europskom socijalnom fondu i stavljanju izvan snage Uredbe Vijeća (EZ) br. 1081/2006, a posebno njezin članak 14. stavak 1.,
With a view to simplifying the use of the European Social Fund ‘ESF’ and reducing the administrative burden for beneficiaries, it is appropriate to increase the scope of standard scales of unit costs and lump sums available for reimbursement to Member States.
U cilju pojednostavnjenja upotrebe Europskog socijalnog fonda („ESF”) i smanjenja administrativnog opterećenja za korisnike primjereno je povećati opseg standardnih veličina jediničnih troškova i paušalnih iznosa koji se mogu nadoknaditi državama članicama.
The standard scales of unit costs and lump sums for reimbursement to Member States should be established on the basis of data submitted by Member States or published by Eurostat and on the basis of methods commonly agreed, including the methods set out in Article 67(5) of Regulation (EU) No 1303/2013 of the European Parliament and of the Council and Article 14(2) and (3) of Regulation (EU) No 1304/2013.
Standardne veličine jediničnih troškova i paušalni iznosi za nadoknadu državama članicama trebali bi se utvrditi na temelju podataka koje dostavljaju države članice ili koje objavljuje Eurostat i na temelju sporazumno dogovorenih metoda, uključujući metode utvrđene člankom 67. stavkom 5. Uredbe (EU) br. 1303/2013 Europskog parlamenta i Vijeća te člankom 14. stavcima 2. i 3. Uredbe (EU) br. 1304/2013.