natgillin/translations-raw huggingface dataset:
Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows:
taumatin
in food category 12.6 ‘Sauces’, the following entry is inserted after the entry for food additive E 955:
samo kot ojačevalec okusa“
‘E 957
v kategoriji živil 15.1 „Prigrizki na osnovi krompirja, žit, moke in škroba“ se za vnosom za aditiv za živila E 955 vstavi naslednji vnos:
Thaumatin
Mnenje z dne 11. decembra 1987 in 10. novembra 1988, sprejeto 10. novembra 1988.
only as flavour enhancer’
Na voljo na spletu: http://aei.pitt.edu/40830/1/21st_food.pdf
amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances
o spremembi in popravku Priloge I k Uredbi (ES) št. 1334/2008 Evropskega parlamenta in Sveta glede uporabe nekaterih aromatičnih snovi
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,
ob upoštevanju Uredbe (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih ter spremembi Uredbe Sveta (EGS) št. 1601/91, uredb (ES) št. 2232/96 in (ES) št. 110/2008 ter Direktive 2000/13/ES in zlasti člena 11(3) Uredbe,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings, and in particular Article 7(5) thereof,
ob upoštevanju Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila ter zlasti člena 7(5) Uredbe,
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.
Priloga I k Uredbi (ES) št. 1334/2008 določa seznam Unije z aromami in izvornimi snovmi za uporabo v živilih ter pogoje 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.
Z Izvedbeno uredbo Komisije (EU) št. 872/2012 je bil sprejet seznam aromatičnih snovi in ta seznam vključen v del A Priloge I k Uredbi (ES) št. 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.
Del A seznama Unije zajema ocenjene aromatične snovi brez opomb in aromatične snovi v postopku ocenjevanja, ki so označene z opombami 1 do 4 v navedenem seznamu.
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.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je zaključila oceno snovi, ki so vključene na seznam Unije z naslednjimi številkami FL: 09.931, 13.058, 15.004, 15.057, 15.079, 15.109 15.113, 16.090 in 16.111.
Those substances were listed as flavouring substances under evaluation in 2012.
Te snovi so bile navedene na seznamu kot aromatične snovi v postopku ocenjevanja v letu 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 jih je ocenila v naslednjih ocenah skupin aromatičnih snovi: ocena FGE.72rev1 (snov s št.
The Authority concluded that those flavouring substances do not give rise to safety concerns at the estimated levels of dietary intakes.
FL 09.931), ocena FGE.21rev4 (snovi s št.
Therefore, those flavouring substances should be listed as evaluated substances and the footnote references 1 to 4 should be deleted from the entries concerned.
FL 15.057 in 15.079), ocena FGE.76rev1 (snovi s št.
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.
FL 15.004, 15.109 in 15.113), oceni FGE.94 in FGE.94rev.2 (snov s št.
Those errors should be corrected.
FL 16.090), oceni FGE.94rev.1 in FGE94rev.2 (snov s št.
Part A of Annex I to Regulation (EC) No 1334/2008 should be amended and corrected accordingly.
FL 16.111) ter ocena FGE.67rev2 (snov s št.
HAS ADOPTED THIS REGULATION:
Agencija je ugotovila, da te aromatične snovi ne predstavljajo tveganja za varnost pri ocenjeni količini, zaužiti s hrano.
Article 1
Zato bi bilo treba zadevne aromatične snovi navesti kot ocenjene snovi, opombe 1 do 4 pa bi bilo treba črtati v zadevnih vnosih.
Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.
Poleg tega sta bili na seznamu Unije ugotovljeni dve napaki, in sicer glede imena snovi s št.
Article 2
FL 12.054 in identifikacijskih številk snovi s št.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Navedene napake bi bilo treba popraviti.
Done at Brussels, 3 May 2018.
Del A Priloge I k Uredbi (ES) št. 1334/2008 bi bilo zato treba ustrezno spremeniti in popraviti.
OJ L 354, 31.12.2008, p. 34.
Člen 1
OJ L 354, 31.12.2008, p. 1.
Del A Priloge I k Uredbi (ES) št. 1334/2008 se spremeni v skladu s Prilogo k tej uredbi.
Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).
Člen 2
EFSA Journal 2013;11(10):3392
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
EFSA Journal 2013;11(11):3451
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
EFSA Journal 2013;11(11):3455
V Bruslju, 3. maja 2018
EFSA Journal 2010; 8(5):1338
Za Komisijo
EFSA Journal 2014;12(4):3622
Predsednik
EFSA Journal 2012;10(6):2747
UL L 354, 31.12.2008, str. 34.
EFSA Journal 2015; 13(5):4115
UL L 354, 31.12.2008, str. 1.
ANNEX
Izvedbena uredba Komisije (EU) št. 872/2012 z dne 1. oktobra 2012 o sprejetju seznama aromatičnih snovi iz Uredbe (ES) št. 2232/96 Evropskega parlamenta in Sveta, njegovi uveljavitvi v Prilogi I k Uredbi (ES) št. 1334/2008 Evropskega parlamenta in Sveta ter razveljavitvi Uredbe Komisije (ES) št. 1565/2000 in Odločbe Komisije 1999/217/ES (UL L 267, 2.10.2012, str. 1).
EFSA’
EFSA Journal (2010); 8(5):1338.
JECFA’
EFSA Journal (2015); 13(5):4115.
The entry concerning FL-No 13.058 is replaced by the following:
PRILOGA
3-(5-Methyl-2-furyl) butanal
Oddelek 2 dela A Priloge I k Uredbi (ES) št. 1334/2008 se spremeni:
The entry concerning FL-No 15.004 is replaced by the following:
Vnos za št.
5-Methyl-2-thiophenecarbaldehyde
FL 09.931 se nadomesti z naslednjim:
The entry concerning FL-No 15.057 is replaced by the following:
2,6-dimetil-2,5,7-oktatrien-1-ol acetat
4,6-Dimethyl-2-(1-methylethyl)dihydro-1,3,5-dithiazine
EFSA“
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
Vnos za št.
The entry concerning FL-No 15.079 is replaced by the following:
FL 12.054 se nadomesti z naslednjim:
2-Isobutyldihydro-4,6- dimethyl-1,3,5- dithiazine
2-etiltiofenol
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
JECFA“
The entry concerning FL-No 15.109 is replaced by the following:
Vnos za št.
2,4,6-Trimethyldihydro-1,3,5(4H)- dithiazine
FL 13.058 se nadomesti z naslednjim:
The entry concerning FL-No 15.113 is replaced by the following:
3-(5-metil-2-furil) butanal
5,6-Dihydro-2,4,6- tris(2-methylpropyl)4H-1,3,5-dithiazine
Vnos za št.
The entry concerning FL-No 16.090 is replaced by the following:
FL 15.004 se nadomesti z naslednjim:
3-(3,4-Dimethoxyphenyl)-N-[2-(3,4-dimethoxyphenyl)-ethyl]- acrylamide
5-metil-2-tiofenkarbaldehid
The entry concerning FL-No 16.111 is replaced by the following:
Vnos za št.
Glycine, N- [[(1R,2S,5R)-5-methyl- 2-(1-methylethyl)cyclohexyl]carbonyl]-, ethyl ester.
FL 15.057 se nadomesti z naslednjim:
The entry concerning FL-No 17.038 is replaced by the following:
4,6-dimetil-2-(1-metiletil)dihidro-1,3,5-ditiazin
gamma-Glutamyl-valyl-glycine
vsaj 44 % izopropil-4,6-dimetila in 27 % 4-izopropil-2,6-dimetila; sekundarne sestavine: vsaj 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
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.
Vnos za št.
10 mg/kg)
FL 15.079 se nadomesti z naslednjim:
Restrictions for use as a flavouring substance:
2-izobutildihidro-4,6-dimetil-1,3,5-ditiazin
In category 1 — not more than 50 mg/kg
vsaj 64 % 2-izobutil-4,6-dimetila in 18 % 4-izobutil-2,6-dimetila; sekundarne sestavine: vsaj 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; nadomeščeni 1,3,5-tiadiazin
In categories 2 and 5 — not more than 60 mg/kg
Vnos za št.
In category 6.3, breakfast cereals — not more than 160 mg/kg
FL 15.109 se nadomesti z naslednjim:
In category 7.2 — not more than 60 mg/kg
2,4,6-trimetildihidro-1,3,5(4H)-ditiazin
In category 8 — not more than 45 mg/kg
Vnos za št.
In category 12 — not more than 160 mg/kg
FL 15.113 se nadomesti z naslednjim:
In category 14.1 — not more than 15 mg/kg
5,6-dihidro-2,4,6-tris(2-metilpropil)4H-1,3,5-ditiazin
Commission Implementing Regulation (EU) 2018/679
Izvedbena 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 obnovitvi odobritve aktivne snovi forklorfenuron v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet ter o spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
Having regard to 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, and in particular Article 20(1) thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS ter zlasti člena 20(1) Uredbe,
Commission Directive 2006/10/EC included forchlorfenuron as an active substance in Annex I to Council Directive 91/414/EEC.
Forklorfenuron je bil z Direktivo Komisije 2006/10/ES vključen v Prilogo I k Direktivi Sveta 91/414/EGS kot aktivna snov.
Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011.
Aktivne snovi, vključene v Prilogo I k Direktivi 91/414/EGS, se štejejo za odobrene v skladu z Uredbo (ES) št. 1107/2009 in so navedene v delu A Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011.
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.
Odobritev aktivne snovi forklorfenuron, kot je določena v delu A Priloge k Izvedbeni uredbi (EU) št. 540/2011, se izteče 31. oktobra 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.
Zahtevek za obnovitev odobritve forklorfenurona je bil predložen v skladu s členom 1 Izvedbene uredbe Komisije (EU) št. 844/2012 v roku, določenem v navedenem členu.
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 poročevalka je pripravila poročilo o oceni obnovitve v posvetovanju z državo članico soporočevalko ter ga 27. maja 2016 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in 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. maja 2017 Komisiji predložila svoj sklep o tem, ali se za forklorfenuron lahko pričakuje, da bo izpolnjeval merila za odobritev iz člena 4 Uredbe (ES) št. 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 osnutek poročila o obnovitvi za forklorfenuron 5. oktobra 2017 predložila Stalnemu odboru za rastline, živali, hrano in krmo.
The Commission invited the applicant to submit its comments on the review report for forchlorfenuron.
Komisija je vlagatelja pozvala, naj predloži pripombe na poročilo o pregledu forklorfenurona.
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.
Ocena tveganja za obnovitev odobritve forklorfenurona temelji na omejenem številu reprezentativnih uporab, kar pa ne omejuje uporab, za katere se za fitofarmacevtska sredstva, ki vsebujejo forklorfenuron, lahko registrirajo.
It is therefore appropriate not to maintain the restriction to use as a plant growth regulator.
Zato je primerno, da se omejitve glede uporabe navedene snovi kot regulatorja rasti rastlin ne ohrani.
It is therefore appropriate to renew the approval of forchlorfenuron.
Zato je primerno obnoviti odobritev forklorfenurona.
In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
V skladu s členom 20(3) Uredbe (ES) št. 1107/2009 v povezavi s členom 13(4) navedene uredbe bi bilo treba ustrezno spremeniti Prilogo k Izvedbeni uredbi Komisije (EU) št. 540/2011.
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.
Z Izvedbeno uredbo Komisije (EU) 2017/1511 je bil podaljšan datum poteka veljavnosti forklorfenurona do 31. oktobra 2018, da bi se omogočil zaključek postopka obnovitve odobritve pred iztekom odobritve navedene aktivne snovi.
Given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 June 2018.
Glede na to, da je sklep o obnovitvi sprejet pred navedenim podaljšanim datumom prenehanja odobritve, bi se ta uredba morala uporabljati od 1. junija 2018.
The approval of the active substance forchlorfenuron is renewed as set out in Annex I.
Odobritev aktivne snovi forklorfenuron se obnovi, kot je določeno v Prilogi I.
It shall apply from 1 June 2018.
Uporablja se od 1. junija 2018.
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 (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS (UL 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/ES z dne 27. januarja 2006 o spremembi Direktive Sveta 91/414/EGS zaradi vključitve forklorfenurona in indoksakarba med aktivne snovi (UL 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, 18 str. Na voljo na spletu: www.efsa.europa.eu.
Commission Implementing Regulation (EU) 2017/1511 of 30 August 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, deltamethrin, dimethenamid-p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, iprodione, MCPA, MCPB, silthiofam, thiophanate-methyl and tribenuron (OJ L 224, 31.8.2017, p. 115).
Izvedbena uredba Komisije (EU) 2017/1511 z dne 30. avgusta 2017 o spremembi Izvedbene uredbe (EU) št. 540/2011 glede podaljšanja obdobja odobritve aktivnih snovi 1-metilciklopropen, beta-ciflutrin, klorotalonil, klorotoluron, cipermetrin, daminozid, deltametrin, dimetenamid-P, flufenacet, flurtamon, forklorfenuron, fostiazat, indoksakarb, iprodion, MCPA, MCPB, siltiofam, tiofanat-metil in tribenuron (UL L 224, 31.8.2017, str. 115).
CAS No 68157-60-8
Št.
CIPAC No 633
CAS 68157-60-8
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.
CIPAC 633
In this overall assessment Member States shall pay particular attention to:
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o obnovitvi snovi forklorfenuron ter zlasti dodatkov I in II k poročilu.
the risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.
V tej celoviti oceni so države članice zlasti pozorne na:
Conditions of use shall include risk mitigation measures, where appropriate.
tveganje za potrošnike v zvezi z morebitnim tveganjem zaradi metabolitov v sadju z užitno lupino.
ANNEX II
Več podrobnosti o identiteti in specifikaciji aktivne snovi je na voljo v poročilu o pregledu
in Part A, entry 118 on forchlorfenuron is deleted;
Priloga k Izvedbeni uredbi (EU) št. 540/2011 se spremeni:
in Part B, the following entry is added:
v delu A se črta vnos 118 za forklorfenuron;
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 izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o obnovitvi snovi forklorfenuron ter zlasti dodatkov I in II k poročilu.
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 spremembi Priloge k Uredbi (EU) št. 231/2012 o določitvi specifikacij za aditive za živila, navedene v prilogah II in III k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta, glede specifikacij 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,
ob upoštevanju Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila in zlasti člena 14 Uredbe,
Commission Regulation (EU) No 231/2012 lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.
V Uredbi Komisije (EU) št. 231/2012 so določene specifikacije za aditive za živila, navedene v prilogah II in III k Uredbi (ES) št. 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’.
V skladu s Prilogo II k Uredbi (ES) št. 1333/2008 je polivinil alkohol-polietilen glikol-graft-kopolimer (E 1209) dovoljen kot aditiv za živila v kategoriji živil 17.1 „Prehranska dopolnila, dobavljena v trdni obliki, vključno s kapsulami in tabletami ter podobnimi oblikami, razen za žvečenje“.
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.
V skladu z veljavnimi specifikacijami EU najvišja dovoljena vsebnost etilen glikola in dietilen glikola, ki sta prisotna kot nečistoči v aditivu za živila polivinil alkohol-polietilen glikol-graft-kopolimer (E 1209), znaša 50 mg/kg za vsakega od njiju.
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).
Dne 26. junija 2015 je bil vložen zahtevek za spremembo specifikacij glede omejitev za etilen glikol in dietilen glikol v polivinil alkohol-polietilen glikol-graft-kopolimeru (E 1209).
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’.
Vložnik je zahteval, da se zvišajo najvišje posamezne omejitve za navedeni nečistoči v specifikacijah polivinil alkohol-polietilen glikol-graft-kopolimera (E 1209) na skupno omejitev „Ne več kot 620 mg/kg za etilen glikol, posamezno ali v kombinaciji z 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.
Vložnik je trdil, da je bila ta specifikacija vključena v prvotni zahtevek, ki ga je Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) ocenila leta 2013, in da je bila predlagana omejitev (620 mg/kg za etilen glikol, posamezno ali v kombinaciji z dietilen glikolom) enaka omejitvi za etilen glikol v farmacevtskih izdelkih.