natgillin/translations-raw huggingface dataset:
Although the Authority calculated the exposure to thaumatin (E 957) using the current maximum use levels and the proposed extension of uses and use levels as provided by the applicant, the use of thaumatin (E 957) as a flavour enhancer should be restricted to those food categories for which there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means and its use will not mislead the consumer.
Iako je Agencija izračunala izloženost taumatinu (E 957) primjenom podataka o postojećoj maksimalnoj razini uporabe i proširenoj uporabi i razinama uporabe koje je predložio podnositelj zahtjeva, uporabu taumatina (E 957) kao pojačivača arome trebalo bi ograničiti na one kategorije hrane za koje postoji razumna tehnološka potreba neostvariva drugim ekonomski ili tehnološki izvedivim načinima, te za koje njegova uporaba neće potrošača dovesti u zabludu.
The use of thaumatin (E 957) as a flavour enhancer improves the organoleptic properties of savoury food products.
Uporabom taumatina (E 957) kao pojačivača arome poboljšavaju se organoleptička svojstva pikantnih prehrambenih proizvoda.
Thaumatin can enhance the existing umami and savoury taste in sauces and snacks, making food products more appealing for human taste.
Taumatin može poboljšati postojeći umami i pikantnost umaka i grickalica, zbog čega prehrambeni proizvod bolje odgovara ljudskom ukusu.
It is therefore appropriate to authorise the use of thaumatin (E 957) as a flavour enhancer in products of food categories 12.6 ‘Sauces’ and 15.1 ‘Potato-, cereal-, flour- or starch-based snacks’ at a maximum level of 5 mg/kg in each food category.
Stoga je primjereno odobriti uporabu taumatina (E 957) kao pojačivača arome u proizvodima kategorija hrane 12.6. „Umaci” i 15.1. „Grickalice na bazi krumpira, žitarica, brašna ili škroba”, do 5 mg/kg za svaku kategoriju hrane.
Reports of the Scientific Committee for Food concerning sweeteners (opinion expressed by the SCF on 14 September 1984).
Izvješća Znanstvenog odbora za hranu o sladilima (mišljenje koje je izrazio Znanstveni odbor za hranu 14. rujna 1984.).
Available online: http://aei.pitt.edu/40825/1/16th_food.pdf
Dostupno na internetu: http://aei.pitt.edu/40825/1/16th_food.pdf
Reports of the Scientific Committee for Food on Sweeteners (21st series).
Izvješća Znanstvenog odbora za hranu o sladilima (21. serija).
EFSA Journal 2015;13(11):4290
EFSA Journal 2015.;13(11):4290.
in food category 12.6 ‘Sauces’, the following entry is inserted after the entry for food additive E 955:
U kategoriji hrane 12.6. „Umaci” nakon unosa za prehrambeni aditiv E 955 umeće se sljedeći unos:
‘E 957
„E 957
Thaumatin
Taumatin
only as flavour enhancer’
samo kao pojačivač arome”
in food category 15.1 ‘Potato-, cereal-, flour- or starch-based snacks’, the following entry is inserted after the entry for food additive E 955:
U kategoriji 15.1. „Grickalice na bazi krumpira, žitarica, brašna ili škroba” nakon unosa za prehrambeni aditiv E 955 umeće se sljedeći unos:
Opinion expressed on 11 December 1987 and 10 November 1988, and adopted 10 November 1988.
Mišljenje izraženo 11. prosinca 1987. i 10. studenoga 1988., a doneseno 10. studenoga 1988.
Available online: http://aei.pitt.edu/40830/1/21st_food.pdf
Dostupno na internetu: http://aei.pitt.edu/40830/1/21st_food.pdf
Commission Regulation (EU) 2018/678
Uredba Komisije (EU) 2018/678
Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC, and in particular Article 11(3) thereof,
uzimajući u obzir Uredbu (EZ) br. 1334/2008 Europskog parlamenta i Vijeća od 16. prosinca 2008. o aromama i nekim sastojcima hrane s osobinama aroma za upotrebu u i na hrani te o izmjeni Uredbe Vijeća (EEZ) br. 1601/91, uredbi (EZ) br. 2232/96 i (EZ) br. 110/2008 te Direktive 2000/13/EZ, a posebno njezin članak 11. stavak 3.,
Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials for use in food and their conditions of use.
U Prilogu I. Uredbi (EZ) br. 1334/2008 utvrđen je Unijin popis aroma i izvornih sirovina za uporabu u hrani te uvjeti njihove uporabe.
Commission Implementing Regulation (EU) No 872/2012 adopted the list of flavouring substances and introduced it as Part A of Annex I to Regulation (EC) No 1334/2008.
Provedbenom uredbom Komisije (EU) br. 872/2012 donesen je popis aromatičnih tvari te je taj popis uvršten u dio A Priloga I. Uredbi (EZ) br. 1334/2008.
Part A of the Union list contains both evaluated flavouring substances, which are assigned no footnotes, and flavouring substances under evaluation, which are identified by footnote references 1 to 4 on the that list.
Dio A popisa Unije sadržava ocijenjene aromatične tvari bez bilješki i aromatične tvari u postupku ocjenjivanja koje su na tom popisu označene bilješkama od 1 do 4.
The European Food Safety Authority ('the Authority') has completed the assessment of the substances included in the Union list with the following FL numbers: 09.931, 13.058, 15.004, 15.057, 15.079, 15.109, 15.113, 16.090 and 16.111.
Europska agencija za sigurnost hrane („Agencija”) završila je ocjenu tvari uvrštenih na popis Unije sa sljedećim FL brojevima: 09.931, 13.058, 15.004, 15.057, 15.079, 15.109, 15.113, 16.090 i 16.111.
Those substances were listed as flavouring substances under evaluation in 2012.
Te su tvari bile navedene na popisu kao aromatične tvari u postupku ocjenjivanja 2012.
They have now been assessed by the Authority in the following flavouring group evaluations: evaluation FGE.72rev1 (substance with FL-No 09.931), evaluation FGE.21rev4 (substances with FL-Nos 15.057 and 15.079), evaluation FGE.76rev1 (substances with FL-Nos 15.004, 15.109 and 15.113), evaluations FGE.94 and FGE.94rev.2 (substance with FL-No 16.090), evaluations FGE.94rev.1 and FGE94rev.2 (substance with FL-No 16.111), and evaluation FGE.67rev2 (substance with FL-No 13.058).
Agencija ih je ocijenila u sljedećim ocjenama skupina aroma: ocjena FGE.72rev1 (tvar s FL brojem 09.931), ocjena FGE.21rev4 (tvari s FL brojevima 15.057 i 15.079), ocjena FGE.76rev1 (tvari s FL brojevima 15.004, 15.109 i 15.113), ocjene FGE.94 i FGE.94rev.2 (tvar s FL brojem 16.090), ocjene FGE.94rev.1 i FGE94rev.2 (tvar s FL brojem 16.111) i ocjena FGE.67rev2 (tvar s FL brojem 13.058).
The Authority concluded that those flavouring substances do not give rise to safety concerns at the estimated levels of dietary intakes.
Agencija je zaključila da navedene aromatične tvari na procijenjenoj razini unosa hrane ne dovode u pitanje sigurnost.
Therefore, those flavouring substances should be listed as evaluated substances and the footnote references 1 to 4 should be deleted from the entries concerned.
Stoga bi navedene aromatične tvari trebalo navesti na popisu kao ocijenjene te bi u odgovarajućim unosima trebalo izbrisati bilješke od 1. do 4.
In addition, two errors have been identified in the Union list as regards the name of the substance with FL-No 12.054 and the identification numbers of the substance with FL-No 17.038.
Osim toga, utvrđene su dvije pogreške u popisu Unije u pogledu naziva tvari s FL brojem 12.054 i identifikacijskih brojeva tvari s FL brojem 17.038.
Part A of Annex I to Regulation (EC) No 1334/2008 should be amended and corrected accordingly.
Dio A Priloga I. Uredbi (EZ) br. 1334/2008 trebalo bi na odgovarajući način izmijeniti i ispraviti.
EFSA Journal 2013;11(10):3392
EFSA Journal 2013.;11(10):3392.
EFSA Journal 2013;11(11):3451
EFSA Journal 2013.;11(11):3451.
EFSA Journal 2013;11(11):3455
EFSA Journal 2013.;11(11):3455.
EFSA Journal 2010; 8(5):1338
EFSA Journal 2010.; 8(5):1338.
EFSA Journal 2014;12(4):3622
EFSA Journal 2014.;12(4):3622.
EFSA Journal 2012;10(6):2747
EFSA Journal 2012.;10(6):2747.
EFSA Journal 2015; 13(5):4115
EFSA Journal 2015.;13(5):4115.
Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:
Dio A odjeljak 2. Priloga I. Uredbi (EZ) br. 1334/2008 mijenja se kako slijedi:
The entry concerning FL-No 09.931 is replaced by the following:
Unos za br. FL 09.931 zamjenjuje se sljedećim:
2,6-Dimethyl-2,5,7-octatriene-1-ol acetate
2,6-dimetil-2,5,7-oktatrien-1-ol acetat
The entry concerning FL-No 12.054 is replaced by the following:
Unos za br. FL 12.054 zamjenjuje se sljedećim:
2-Ethylthiophenol
2-etiltiofenol
The entry concerning FL-No 13.058 is replaced by the following:
Unos za br. FL 13.058 zamjenjuje se sljedećim:
3-(5-Methyl-2-furyl) butanal
3-(5-metil-2-furil) butanal
The entry concerning FL-No 15.004 is replaced by the following:
Unos za br. FL 15.004 zamjenjuje se sljedećim:
5-Methyl-2-thiophenecarbaldehyde
5-metil-2-tiofenekarbaldehid
The entry concerning FL-No 15.057 is replaced by the following:
Unos za br. FL 15.057 zamjenjuje se sljedećim:
4,6-Dimethyl-2-(1-methylethyl)dihydro-1,3,5-dithiazine
4,6-dimetil-2-(1-metiletil)dihidro-1,3,5-ditiazin
At least 44 % isopropyl-4,6-dimethyl and 27 % 4-isopropyl-2,6-dimethyl; secondary components at least 24 % 2,4,6-trimethyldihydro-1,3,5-dithiazine; 6-methyl-2,4- diisopropyl-1,3,5-dithiazine; 4-methyl-2,6- diisopropyl-1,3,5-dithiazine; 2,4,6-triisopropyl-dihydro-1,3,5-dithiazine
Najmanje 44 % izopropil-4,6-dimetila i 27 % 4-izopropil-2,6-dimetila; sekundarni sastojci: najmanje 24 % 2,4,6-trimetildihidro-1,3,5-ditiazina; 6-metil-2,4-diizopropil-1,3,5-ditiazin; 4-metil-2,6-diizopropil-1,3,5-ditiazin; 2,4,6-triizopropil-dihidro-1,3,5-ditiazin
The entry concerning FL-No 15.079 is replaced by the following:
Unos za br. FL 15.079 zamjenjuje se sljedećim:
2-Isobutyldihydro-4,6- dimethyl-1,3,5- dithiazine
2-izobutildihidro-4,6-dimetil-1,3,5-ditiazin
At least 64 % 2-isobutyl-4,6-dimethyl and 18 % 4-isobutyl-2,6-dimethyl; secondary components at least 13 % 2,4,6-trimethyl- 1,3,5-dithiazine; 2,4-diisobutyl-6-methyl- 1,3,5-dithiazine; 2,6-dimethyl-4- butyldihydro-1,3,5-dithiazine; substituted 1,3,5-thiadiazine
Najmanje 64 % 2-izobutil-4,6-dimetila i 18 % 4-izobutil-2,6-dimetila; sekundarni sastojci: najmanje 13 % 2,4,6-trimetil-1,3,5-ditiazina; 2,4-diizobutil-6-metil-1,3,5-ditiazin; 2,6-dimetil-4-butildihidro-1,3,5-ditiazin; supstituirani 1,3,5-tiadiazin
The entry concerning FL-No 15.109 is replaced by the following:
Unos za br. FL 15.109 zamjenjuje se sljedećim:
2,4,6-Trimethyldihydro-1,3,5(4H)- dithiazine
2,4,6-trimetildihidro-1,3,5(4H)-ditiazin
The entry concerning FL-No 15.113 is replaced by the following:
Unos za br. FL 15.113 zamjenjuje se sljedećim:
5,6-Dihydro-2,4,6- tris(2-methylpropyl)4H-1,3,5-dithiazine
5,6-dihidro-2,4,6-tris(2-metilpropil)4H-1,3,5-ditiazin
The entry concerning FL-No 16.090 is replaced by the following:
Unos za br. FL 16.090 zamjenjuje se sljedećim:
3-(3,4-Dimethoxyphenyl)-N-[2-(3,4-dimethoxyphenyl)-ethyl]- acrylamide
3-(3,4-dimetoksifenil)-N-[2-(3,4-dimetoksifenil)-etil]-akrilamid
The entry concerning FL-No 16.111 is replaced by the following:
Unos za br. FL 16.111 zamjenjuje se sljedećim:
Glycine, N- [[(1R,2S,5R)-5-methyl- 2-(1-methylethyl)cyclohexyl]carbonyl]-, ethyl ester.
glicin, N-[[(1R,2S,5R)-5-metil-2-(1-metiletil)cikloheksil]karbonil]-, etil ester
The entry concerning FL-No 17.038 is replaced by the following:
Unos za br. FL 17.038 zamjenjuje se sljedećim:
gamma-Glutamyl-valyl-glycine
gama-glutamil-valil-glicin
5-oxo-L-prolyl-L-valyl-glycine (PCA-Val-Gly) and L-alpha-glutamyl-L-valyl-glycine less than 0,7 %, L-gamma-glutamyl-L-valyl-L-valyl-glycine less than 2,0 %, Toluene not detectable (l.o.d. 10 mg/kg)
5-okso-L-prolil-L-valil-glicin (PCA-Val-Gly) i L-alfa-glutamil-L-valil-glicin manje od 0,7 %, L-gama-glutamil-L-valil-L-valil-glicin manje od 2,0 %, toluen se ne može utvrditi (granica za utvrđivanje 10 mg/kg)
In category 6.3, breakfast cereals — not more than 160 mg/kg
u kategoriji 6.3, žitarice za doručak, – ne više od 160 mg/kg
Commission Implementing Regulation (EU) 2018/679
Provedbena uredba Komisije (EU) 2018/679
renewing the approval of the active substance forchlorfenuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o produljenju odobrenja aktivne tvari forklorfenuron u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja i o izmjeni Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011
Commission Directive 2006/10/EC included forchlorfenuron as an active substance in Annex I to Council Directive 91/414/EEC.
Direktivom Komisije 2006/10/EZ forklorfenuron uvršten je u Prilog I. Direktivi Vijeća 91/414/EEZ kao aktivna tvar.
The approval of the active substance forchlorfenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2018.
Odobrenje aktivne tvari forklorfenuron, kako je navedena u dijelu A Priloga Provedbenoj uredbi (EU) br. 540/2011, istječe 31. listopada 2018.
An application for the renewal of the approval of forchlorfenuron was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
Zahtjev za produljenje odobrenja aktivne tvari forklorfenuron podnesen je u skladu s člankom 1. Provedbene uredbe Komisije (EU) br. 844/2012 u roku predviđenom tim člankom.
The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012.
Podnositelj zahtjeva dostavio je dodatnu dokumentaciju u skladu sa zahtjevima iz članka 6. Uredbe (EU) br. 844/2012.
The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 27 May 2016.
Država članica izvjestiteljica nakon savjetovanja s državom članicom suizvjestiteljicom pripremila je izvješće o ocjeni produljenja i dostavila ga 27. svibnja 2016. Europskoj agenciji za sigurnost hrane („Agencija”) i Komisiji.
On 31 May 2017 the Authority communicated to the Commission its conclusion on whether forchlorfenuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Agencija je 31. svibnja 2017. Komisiji dostavila zaključak o tome može li se pretpostaviti da forklorfenuron ispunjava mjerila za odobravanje iz članka 4. Uredbe (EZ) br. 1107/2009.
The Commission presented the draft renewal report for forchlorfenuron to the Standing Committee on Plants, Animals, Food and Feed on 5 October 2017.
Komisija je 5. listopada 2017. Stalnom odboru za bilje, životinje, hranu i hranu za životinje dostavila nacrt izvješća o produljenju za forklorfenuron.
The Commission invited the applicant to submit its comments on the review report for forchlorfenuron.
Komisija je podnositelja zahtjeva pozvala da dostavi primjedbe o izvješću o pregledu za forklorfenuron.
The risk assessment for the renewal of the approval of forchlorfenuron is based on a limited number of representative uses, which however does not restrict the uses for which plant protection products containing forchlorfenuron may be authorised.
Procjena rizika za produljenje odobrenja aktivne tvari forklorfenuron temelji se na ograničenom broju reprezentativnih uporaba, no time se ne ograničavaju uporabe za koje se mogu odobriti sredstva za zaštitu bilja koja sadržavaju forklorfenuron.
It is therefore appropriate not to maintain the restriction to use as a plant growth regulator.
Stoga nije primjereno zadržati ograničenje za uporabu te tvari isključivo kao sredstva za reguliranje rasta biljaka.
It is therefore appropriate to renew the approval of forchlorfenuron.
Stoga je primjereno produljiti odobrenje za forklorfenuron.
Commission Implementing Regulation (EU) 2017/1511 extended the expiry date of forchlorfenuron to 31 October 2018 in order to allow the renewal process to be completed before the expiry of the approval of that active substance.
Provedbenom uredbom Komisije (EU) 2017/1511 datum isteka odobrenja za forklorfenuron produljen je do 31. listopada 2018. kako bi se postupak produljenja mogao završiti prije isteka roka valjanosti odobrenja te aktivne tvari.
Given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 June 2018.
S obzirom na to da je odluka o produljenju odobrenja donesena prije novog datuma prestanka odobrenja, ova Uredba trebala bi se primjenjivati od 1. lipnja 2018.
The approval of the active substance forchlorfenuron is renewed as set out in Annex I.
Odobrenje aktivne tvari forklorfenuron produljuje se kako je navedeno u Prilogu I.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
Uredba (EZ) br. 1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ (SL L 309, 24.11.2009., str. 1).
Commission Directive 2006/10/EC of 27 January 2006 amending Council Directive 91/414/EEC to include forchlorfenuron and indoxacarb as active substances (OJ L 25, 28.1.2006, p. 24).
Direktiva Komisije 2006/10/EZ od 27. siječnja 2006. o izmjenama i dopunama Direktive Vijeća 91/414/EEZ radi uvrštenja forklorfenurona i indoksakarba među djelatne tvari (SL L 25, 28.1.2006., str. 24.).
EFSA Journal 2017;15(6):4874, 18 pp. Available online: www.efsa.europa.eu.
EFSA Journal 2017.;15(6):4874, str. 18. Dostupno na internetu: www.efsa.europa.eu.
CAS No 68157-60-8
CAS br. 68157-60-8
CIPAC No 633
CIPAC br. 633
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on forchlorfenuron, and in particular Appendices I and II thereof, shall be taken into account.
Za provedbu jedinstvenih načela iz članka 29. stavka 6. Uredbe (EZ) br. 1107/2009 moraju se uzeti u obzir zaključci izvješća o produljenju za forklorfenuron, a posebno njegovi dodaci I. i II.
the risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.
rizik za potrošače s obzirom na potencijalni rizik od metabolita u voćnim kulturama s jestivom korom.
in Part A, entry 118 on forchlorfenuron is deleted;
U dijelu A briše se unos 118. za forklorfenuron.
Further details on identity and specification of active substance are provided in the review report.’
Dodatni podaci o identifikaciji i specifikaciji aktivne tvari dostupni su u izvješću o pregledu.”
31.5.2033
31.5.2033.
Commission Regulation (EU) 2018/681
Uredba Komisije (EU) 2018/681
amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for Polyvinyl alcohol-polyethylene glycol graft-co-polymer (E 1209)
o izmjeni Priloga Uredbi (EU) br. 231/2012 o utvrđivanju specifikacija za prehrambene aditive navedene u prilozima II. i III. Uredbi (EZ) br. 1333/2008 Europskog parlamenta i Vijeća u pogledu specifikacija za polivinil alkohol-polietilen glikol graft-kopolimer (E 1209)
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, and in particular Article 14 thereof,
uzimajući u obzir Uredbu (EZ) br. 1333/2008 Europskog parlamenta i Vijeća od 16. prosinca 2008. o prehrambenim aditivima, a posebno njezin članak 14.,
Commission Regulation (EU) No 231/2012 lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.
Uredbom Komisije (EU) br. 231/2012 utvrđene su specifikacije za prehrambene aditive navedene u prilozima II. i III. Uredbi (EZ) br. 1333/2008.
In accordance with Annex II to Regulation (EC) No 1333/2008, polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209) is authorised as a food additive in the food category 17.1 ‘food supplements supplied in a solid form including capsules and tablets, excluding chewable forms’.
U skladu s Prilogom II. Uredbi (EZ) br. 1333/2008, polivinil alkohol-polietilen glikol-graft-kopolimer (E 1209) odobren je kao prehrambeni aditiv u kategoriji hrane 17.1. „dodaci prehrani u krutom obliku, uključujući kapsule i tablete, osim oblika za žvakanje”.
According to the current EU specifications, the maximum permissible amount of ethylene glycol and diethylene glycol, which are present as impurities in the food additive polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209), is 50 mg/kg for each of them.
Prema važećim specifikacijama EU-a, najveća dopuštena količina etilen glikola i dietilen glikola, koji su prisutni kao nečistoće u prehrambenom aditivu polivinil alkohol-polietilen glikol-graft-kopolimeru (E 1209), jest 50 mg/kg za svaki od njih.
On 26 June 2015 an application was submitted for the amendment of the specifications regarding the limits for ethylene glycol and diethylene glycol in polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209).
Zahtjev za izmjenu specifikacija u pogledu ograničenja za etilen glikol i dietilen glikol u polivinil alkohol-polietilen glikol-graft-kopolimeru (E 1209) podnesen je 26. lipnja 2015.
The applicant requested to increase the maximum individual limits for those two impurities in the specifications of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209) to an overall limit of ‘Not more than 620 mg/kg for ethylene glycol individually or in combination with diethylene glycol’.
Podnositelj zahtjeva zatražio je povećanje najveće dopuštene pojedinačne količine za te dvije nečistoće u specifikacijama polivinil alkohol-polietilen glikol-graft-kopolimera (E 1209) na ukupno ograničenje od „ne više od 620 mg/kg za etilen glikol pojedinačno ili u kombinaciji s dietilen glikolom”.
The applicant claimed that this specification was included in the original application that was assessed by the European Food Safety Authority (‘the Authority’) in 2013 and that the proposed limit (620 mg/kg for ethylene glycol individually or in combination with diethylene glycol) was identical to the limit for ethylene glycol in pharmaceutical products.
Podnositelj zahtjeva tvrdio je da je ta specifikacija bila uvrštena u prvotni zahtjev koji je Europska agencija za sigurnost hrane („Agencija”) ocijenila 2013. te da je predloženo ograničenje (620 mg/kg za etilen glikol pojedinačno ili u kombinaciji s dietilen glikolom) jednako graničnoj vrijednosti za etilen glikol u farmaceutskim proizvodima.
In its opinion of 18 May 2017 the Authority concluded that the applicant's request would result in total exposure from food additive uses below the group tolerable daily intake (TDI) of 0,5 mg/kg body weight/day allocated by the Scientific Committee on Food (SCF) and that the amendment to the specifications as regards the level of the impurities ethylene glycol and diethylene glycol in polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209) proposed by the applicant is not of a safety concern.
U mišljenju od 18. svibnja 2017. Agencija je zaključila da bi zbog podnositeljeva zahtjeva ukupna izloženost od uporabe kao prehrambenog aditiva bila niža od skupno prihvatljivog dnevnog unosa (TDI) od 0,5 mg/kg tjelesne mase/dan, kako je odredio Znanstveni odbor za hranu (SCF) te da izmjena specifikacija u pogledu razine nečistoća etilen glikola i dietilen glikola u polivinil alkohol-polietilen glikol-graft-kopolimeru (E 1209) koju je predložio podnositelj zahtjeva ne predstavlja sigurnosni rizik.