natgillin/translations-raw huggingface dataset:
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
društvu: Mitsubishi Gas Chemical Company, Inc.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
adresa: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan ;
Done at Brussels, 10 August 2018.
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 Mitsubishi Gas Chemical Company, Inc.
For the Commission
Unos na popis Unije iz prvog stavka uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
The President
Odobrenjem iz ovog članka ne dovode se u pitanje odredbe Direktive 2002/46/EZ.
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).
Studije iz dosjea podnositelja zahtjeva na temelju kojih je Agencija provela ocjenu nove hrane iz članka 1., na koju 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 Mitsubishi Gas Chemical Company, Inc.
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).
Članak 3.
EFSA Journal 2017; 15(11):5058.
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se u skladu s Prilogom ovoj Uredbi.
Mitsubishi Gas Chemical Company Inc., 2005b (unpublished report).
Članak 4.
Mitsubishi Gas Chemical Company Inc., 2008b (unpublished report).
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Mitsubishi Gas Chemical Company Inc., 2006d (unpublished report).
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Mitsubishi Gas Chemical Company Inc., 2006c (unpublished report).
Sastavljeno u Bruxellesu 10. kolovoza 2018.
Mitsubishi Gas Chemical Company Inc., 2005a (unpublished report).
Za Komisiju
Mitsubishi Gas Chemical Company Inc., 2006b (unpublished report).
Predsjednik
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.
SL L 327, 11.12.2015., str. 1.
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).
Provedbena uredba Komisije (EU) 2017/2470 оd 20. prosinca 2017. o utvrđivanju Unijina popisa nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća o novoj hrani (SL L 351, 30.12.2017., str. 72.).
ANNEX
Uredba (EZ) br. 258/97 Europskog parlamenta i Vijeća od 27. siječnja 1997. o novoj hrani i sastojcima nove hrane (SL L 43, 14.2.1997., str. 1.).
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
EFSA Journal 2017.; 15(11):5058.
the following last column is added in Table 1 (Authorised novel foods):
Mitsubishi Gas Chemical Company Inc., 2005b (neobjavljeno izvješće).
‘Data Protection’
Mitsubishi Gas Chemical Company Inc., 2008b (neobjavljeno izvješće).
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
Mitsubishi Gas Chemical Company Inc., 2006d (neobjavljeno izvješće).
Authorised novel food
Mitsubishi Gas Chemical Company Inc., 2006c (neobjavljeno izvješće).
Conditions under which the novel food may be used
Mitsubishi Gas Chemical Company Inc., 2005a (neobjavljeno izvješće).
Additional specific labelling requirements
Mitsubishi Gas Chemical Company Inc., 2006b (neobjavljeno izvješće).
Other requirements
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.
Data Protection
Direktiva 2002/46/EZ Europskog parlamenta i Vijeća od 10. lipnja 2002. o usklađivanju zakona država članica u odnosu na dodatke prehrani (SL L 183, 12.7.2002., str. 51.).
‘Pyrroloquinoline quinone disodium salt
PRILOG
Maximum levels
Sljedeći zadnji stupac umeće se u tablicu 1.
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Pyrroloquinoline quinone disodium salt”.
(Odobrena nova hrana):
Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:
„Zaštita podataka”
This food supplement should be consumed by adults only excluding pregnant and lactating women
Sljedeći unos umeće se abecednim redom u tablicu 1.
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Odobrena nova hrana
Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
Uvjeti pod kojima se nova hrana može upotrebljavati
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.
Dodatni posebni zahtjevi za označivanje proizvoda
End date of the data protection: 2 september 2023’
Ostali zahtjevi
Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women
Zaštita podataka
20 mg/day
„Dinatrijeva sol pirolokinolin kinona
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Određena kategorija hrane
Authorised Novel Food
Najveće dopuštene količine
Specification
Pri označivanju hrane koja sadržava novu hranu navodi se „dinatrijeva sol pirolokinolin kinona”.
Definition:
Na dodacima prehrani koji sadržavaju dinatrijevu sol pirolokinolin kinona navodi se sljedeća izjava:
Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate
Ovaj dodatak prehrani smiju konzumirati samo odrasli, isključujući trudnice i dojilje
Chemical formula: C14H4N2Na2O8
Podnositelj zahtjeva: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan
CAS No: 122628-50-6
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.
Molecular weight: 374,17 Da
Uredbe (EU) 2015/2283 ili uz suglasnost društva Mitsubishi Gas Chemical Company, Inc.
Description
Datum završetka zaštite podataka: 2. rujna 2023.”
Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni općoj populaciji, isključujući trudnice i dojilje
Characteristics/Composition
20 mg dnevno
Appearance: Reddish-brown powder
Sljedeći unos umeće se abecednim redom u tablicu 2.
Purity: ≥ 99,0 % (dry weight)
(Specifikacije):
UV absorbance (A322/A259): 0,56 ± 0,03
Odobrena nova hrana
UV absorbance (A233/A259): 0,90 ± 0,09
Specifikacija
Moisture: ≤ 12,0 %
Definicija:
Residual Solvent
Kemijski naziv: dinatrijev 9-karboksi-4,5-diokso-1H-pirolo[5,4-f]kinolin-2,7-dikarboksilat
Ethanol: ≤ 0,05 %
Kemijska formula: C14H4N2Na2O8
Heavy metals
CAS br.: 122628-50-6
Lead: < 3 mg/kg
Molekulska masa: 374,17 Da
Arsenic: < 2 mg/kg
Opis
Microbiological criteria:
Dinatrijeva sol pirolokinolin kinona je crvenkastosmeđi prah proizveden od negenetski modificirane bakterije Hyphomicrobium denitrificans soj CK-275.
Total viable cell count: ≤ 300 CFU/g
Svojstva/sastav
Mould/yeast: ≤ 12 CFU/g
Izgled: crvenkastosmeđi prah
Coliforms: absent in 1 g
Čistoća: ≥ 99,0 % (suhe tvari)
CFU: Colony Forming Units’
Apsorpcija UV svjetla (A322/A259): 0,56 ± 0,03
Authorised on 2 September 2018.
Apsorpcija UV svjetla (A233/A259): 0,90 ± 0,09
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
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.
Na temelju članka 8.
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.
Na temelju članka 12.
The application requests for 1-methylnicotinamide chloride to be used in food supplements for the general adult population, excluding pregnant and lactating women.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
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.
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.
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.
Zahtjevom se tražilo odobrenje uporabe 1-metilnikotinamid klorida u dodacima prehrani za opću populaciju odraslih, osim trudnica i dojilja.
On 26 November 2015, the competent authority of the United Kingdom issued its initial assessment report.
U skladu s člankom 35. stavkom 1.
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.
Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište Unije koji su podneseni državi članici u skladu s člankom 4.
On 11 December 2015, the Commission forwarded the initial assessment report to the other Member States.
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.
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.
Zahtjev za stavljanje na tržište Unije 1-metilnikotinamid klorida kao nove hrane podnesen je državi članici u skladu s člankom 4.
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
Uredbe (EZ) br. 258/97, a ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
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’.
Nadležno tijelo Ujedinjene Kraljevine izdalo je 26. studenoga 2015. izvješće o početnoj procjeni.
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.
U tom je izvješću zaključeno da 1-metilnikotinamid klorid ispunjava kriterije za novi sastojak hrane utvrđene člankom 3. stavkom 1.
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.
Uredbe (EZ) br. 258/97.
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.
Komisija je 11. prosinca 2015. izvješće o početnoj procjeni proslijedila ostalim državama članicama.
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.
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.
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.
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.
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.
Agencija je 20. rujna 2017. donijela „Znanstveno mišljenje o sigurnosti 1-metilnikotinamid klorida kao nove hrane u skladu s Uredbom (EZ) br. 258/97”.
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.
Iako je EFSA to mišljenje izradila i donijela na temelju Uredbe (EZ) br. 258/97, ono je u skladu sa zahtjevima iz članka 11.
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.
Uredbe (EU) 2015/2283.
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.
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.
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.
Uredbe (EU) 2015/2283.
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.
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.
Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements.
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.
The use of 1-methylnicotinamide chloride should be authorised without prejudice to that Directive.
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.
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.
U skladu s tim, kako je predviđeno člankom 26. stavkom 2.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
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.
Wolczanska 178, 90 530 Lodz, Poland
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.
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.
Direktivom 2002/46/EZ Europskog parlamenta i Vijeća utvrđuju se zahtjevi o dodacima prehrani.
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.
Uporabu 1-metilnikotinamid klorida trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
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.
Članak 1.
Article 3
1-metilnikotinamid klorid, kako je navedeno u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen Provedbenom uredbom (EU) 2017/2470.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
U razdoblju od pet godina od dana stupanja na snagu ove Uredbe odobrava se isključivo prvotnom podnositelju zahtjeva:
Article 4
adresa: ul.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Wolczanska 178, 90 530 Lodz, Poljska ;
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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.
Done at Brussels, 10 August 2018.
Unos na popis Unije iz prvog stavka uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
OJ L 327, 11.12.2015, p. 1.
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.
Članak 4.
Unpublished internal company report.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Przybyła M., 2013, unpublished report.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Proskin, H.M., 2008, unpublished report.
Sastavljeno u Bruxellesu 10. kolovoza 2018.
Stepnik M., 2012, unpublished report.
Za Komisiju
Cossette M., 2009, unpublished report.
Predsjednik
Ford J.A., 2014, unpublished study.
SL L 327, 11.12.2015., str. 1.