natgillin/translations-raw huggingface dataset:
For the Commission
Uredba Komisije (EU) št. 2017/776 z dne 4. maja 2017 o spremembi Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta o razvrščanju, označevanju in pakiranju snovi ter zmesi z namenom njene prilagoditve tehničnemu in znanstvenemu napredku (UL L 116, 5.5.2017, str. 1).
The President
Telesna teža.
OJ L 353, 31.12.2008, p. 1.
Uredba Komisije (EU) 2018/669 z dne 16. aprila 2018 o spremembi Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta o razvrščanju, označevanju in pakiranju snovi ter zmesi z namenom njene prilagoditve tehničnemu in znanstvenemu napredku (UL L 115, 4.5.2018, str. 1).
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1).
Uredba (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH), o ustanovitvi Evropske agencije za kemikalije ter spremembi Direktive 1999/45/ES ter razveljavitvi Uredbe Sveta (EGS) št. 793/93 in Uredbe Komisije (ES) št. 1488/94 ter Direktive Sveta 76/769/EGS in direktiv Komisije 91/155/EGS, 93/67/EGS, 93/105/ES in 2000/21/ES (UL L 396, 30.12.2006, str. 1).
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).
Uredba (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov (UL L 167, 27.6.2012, str. 1).
Commission Regulation (EU) 2016/1179 of 19 July 2016 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 195, 20.7.2016, p. 11).
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 Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 116, 5.5.2017, p. 1).
PRILOGA
Body weight.
Priloga VI k Uredbi (ES) št. 1272/2008 se spremeni:
Commission Regulation (EU) 2018/669 of 16 April 2018 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 115, 4.5.2018, p. 1).
v delu 1 se naslov točke 1.1.1.4 nadomesti z naslednjim:
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
„Kemijsko ime“;
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
v delu 3 se tabela 3.1 spremeni:
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).
naslov drugega stolpca se glasi: „Kemijsko ime“;
ANNEX
naslov predzadnjega stolpca se nadomesti z naslednjim: „Posebne mejne koncentracije, M-faktorji in ATE (*)
Annex VI to Regulation (EC) No 1272/2008 is amended as follows:
ATE za oralno in dermalno izpostavljenost je izražen v mg/kg tt, kar pomeni miligram na kilogram telesne teže.“
in Part 1, the heading of point 1.1.1.4 is replaced by the following:
vnos pri indeksni številki 607-414-00-6 se črta;
‘Chemical name’;
vnosi pri indeksnih številkah 006-044-00-7, 015-101-00-5, 016-096-00-2, 017-011-00-1, 025-002-00-9, 603-180-00-4, 604-014-00-3, 604-016-00-4, 604-090-00-8, 605-003-00-6, 606-047-009, 607-096-00-9, 607-103-00-5, 607-113-00-X, 607-373-00-4, 613-167-00-5, 613-205-00-0 in 614-001-00-4 se nadomestijo z naslednjimi vnosi:
in Part 3, Table 3.1 is amended as follows:
Indeks št.
the title of the second column is replaced by the following: ‘Chemical name’;
Kemijsko ime
the title of the penultimate column is replaced by the following: ‘Specific Conc.
Št.
Limits, M-factors and ATEs (*)
ES
ATEs for oral and dermal exposure routes are expressed in mg/kg bw, which stands for milligram per kilogram bodyweight.’;
Št.
the entry corresponding to index number 607-414-00-6 is deleted;
CAS
the entries corresponding to index numbers 006-044-00-7, 015-101-00-5, 016-096-00-2, 017-011-00-1, 025-002-00-9, 603-180-00-4, 604-014-00-3, 604-016-00-4, 604-090-00-8, 605-003-00-6, 606-047-009, 607-096-00-9, 607-103-00-5, 607-113-00-X, 607-373-00-4, 613-167-00-5, 613-205-00-0 and 614-001-00-4 are replaced by the following entries respectively:
Razvrstitev
Index No
Označitev
Chemical name
Posebne mejne koncentracije, M-Faktorji in ATE
EC No
Opombe
Limits, M-factors and ATEs
„006-044-00-7
Notes
izoproturon (ISO);
Hazard Class and Category Code(s)
3-(4-izopropilfenil)-1,1-dimetilsečnina
Hazard statement Code(s)
H373 (kri)
Pictogram, Signal Word Code(s)
M = 10“
Suppl.
„015-101-00-5
‘006-044-00-7
S-[(1,3-diokso-1,3-dihidro-2H-izoindol-2-il)metil] O,O-dimetil fosforoditioat;
isoproturon (ISO);
O,O-dimetil-S-ftalimidometil fosforoditioat
3-(4-isopropylphenyl)-1,1-dimethylurea
H370 (živčni sistem)
H373 (blood)
M = 100“
M = 10’
„016-096-00-2
‘015-101-00-5
metil tifensulfuron (ISO);
phosmet (ISO);
metil 3-(4-metoksi-6-metil-1,3,5-triazin-2-ilkarbamoilsulfamoil)tiofen-2-karboksilat
S-[(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)methyl] O,O-dimethyl phosphorodithioate;
„017-011-00-1
O,O-dimethyl-S-phthalimidomethyl phosphorodithioate
natrijev hipoklorit, raztopina … % aktivnega klora
H370 (nervous system)
„025-002-00-9
M = 100’
kalijev permanganat
‘016-096-00-2
„603-180-00-4
thifensulfuron-methyl (ISO);
holekalciferol;
methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate
holekalciferol;
‘017-011-00-1
vdihavanje:
‘025-002-00-9
dermalno:
potassium permanganate
ATE = 50 mg/kg tt
‘603-180-00-4
oralno:
colecalciferol;
ATE = 35 mg/kg tt
cholecalciferol;
STOT RE 1; H372: C ≥ 3 %
vitamin D3
STOT RE 2; H373: 0,3 % ≤ C < 3 %“
inhalation:
„604-014-00-3
ATE = 0,05 mg/L (dusts or mists)
klorokrezol;
dermal:
4-kloro-m-krezol;
ATE = 50 mg/kg bw
4-kloro-3-metilfenol
oral:
„604-016-00-4
ATE = 35 mg/kg bw
1,2-dihidroksibenzen;
STOT RE 1; H372: C ≥ 3 %
pirokatehol
STOT RE 2; H373: 0,3 % ≤ C < 3 %’
ATE = 300 mg/kg tt
‘604-014-00-3
ATE = 600 mg/kg tt“
chlorocresol;
„604-090-00-8
4-chloro-m-cresol;
4-terc-butilfenol
4-chloro-3-methylphenol
„605-003-00-6
‘604-016-00-4
Acetaldehid;
1,2-dihydroxybenzene;
etanal
pyrocatechol
„606-047-00-9
ATE = 300 mg/kg bw
2-benzil-2-dimetilamino-4′-morfolinobutirofenon
ATE = 600 mg/kg bw’
„607-096-00-9
‘604-090-00-8
anhidrid maleinske kisline
4-tert-butylphenol
H372 (respiratorni sistem) (vdihavanje)
‘605-003-00-6
1A; H317: C ≥ 0,001 %“
acetaldehyde;
„607-103-00-5
ethanal
anhidrid sukcinske kisline
‘606-047-00-9
EUH071“
2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone
„607-113-00-X
‘607-096-00-9
izobutil metakrilat
maleic anhydride
„607-373-00-4
H372 (respiratory system) (inhalation)
kvizalofop-P-tefuril (+/–)-tetrahidrofurfuril (R)-2-[4-(6-klorokinoksalin-2-iloksi)feniloksi]propionat
1A; H317: C ≥ 0,001 %’
„613-167-00-5
‘607-103-00-5
reakcijska zmes 5-kloro-2-metil-2h-izotiazol-3-ona in 2-metil-2h-izotiazol-3-ona (3:1)
succinic anhydride
1; H318: C ≥ 0,6 %
EUH071’
„613-205-00-0
‘607-113-00-X
propikonazol (ISO); (2RS,4RS;2RS,4SR)-1-[[2-(2,4-diklorofenil)-4-propil-1,3-dioksolan-2-il]metil]-1H-1,2,4-triazol
‘607-373-00-4
nikotin (ISO);
quizalofop-P-tefuryl (ISO); (+/–) tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate
3-[(2S)-1-metilpirolidin-2-il]piridin
‘613-167-00-5
ATE = 0,19 mg/l (prah ali meglice)
reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1)
ATE = 70 mg/kg tt
1; H318: C ≥ 0,6 %
ATE = 5 mg/kg tt“
1A; H317: C ≥ 0,0015 %
naslednji vnosi se vstavijo na ustrezna mesta v skladu z zaporedjem vnosov iz tabele 3.1:
‘613-205-00-0
„604-094-00-X
propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl-1H-1,2,4-triazole
izoevgenol; [1]
‘614-001-00-4
(E)-2-metoksi-4-(prop-1-enil)fenol; [2]
nicotine (ISO);
(Z)-2-metoksi-4-(prop-1-enil)fenol [3]
3-[(2S)-1-methylpyrrolidin-2-yl]pyridine
1A; H317: C ≥ 0,01 %“
ATE = 0,19 mg/L (dusts or mists)
„607-724-00-1
ATE = 70 mg/kg bw
2,3,5,6-tetrafluoro-4-(metoksimetil)benzil (1R,3R)-2,2-dimetil-3-[(1Z)-prop-1-en-1-il]ciklopropankarboksilat; epsilon-metoflutrin
ATE = 5 mg/kg bw’
„607-725-00-7
the following entries are inserted in the appropriate places, following the order of the entries set out in Table 3.1:
izopropil (2E,4E,7S)-11-metoksi-3,7,11-trimetildodeka-2,4-dienoat; S-metopren
‘604-094-00-X
„607-726-00-2
isoeugenol; [1]
pinoksaden (ISO);
(E)-2-methoxy-4-(prop-1-enyl)phenol; [2]
8-(2,6-dietil-4-metilfenil)-7-okso-1,2,4,5-tetrahidro-7H-pirazolo[1,2-d][1,4,5]oksadiazepin-9-il 2,2-dimetilpropanoat
(Z)-2-methoxy-4-(prop-1-enyl)phenol [3]
ATE = 4,63 mg/l (prah ali meglice)
1A; H317: C ≥ 0,01 %’
ATE = 500 mg/kg
‘607-724-00-1
„607-727-00-8
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (1R,3R)-2,2-dimethyl-3-[(1Z)-prop-1-en-1-yl]cyclopropanecarboxylate; epsilon-metofluthrin
tetrametrin (ISO);
‘607-725-00-7
(1,3-diokso-1,3,4,5,6,7-heksahidro-2H-izoindol-2-il)metil 2,2-dimetil-3-(2-metilprop-1-en-1-il)ciklopropankarboksilat
isopropyl (2E,4E,7S)-11-methoxy-3,7,11-trimethyldodeca-2,4-dienoate; S-methoprene
H371 (živčni sistem) (vdihavanje)
‘607-726-00-2
„607-728-00-3
pinoxaden (ISO);
(1,3,4,5,6,7-heksahidro-1,3-diokso-2H-izoindol-2-il)metil (1R-trans)-2,2-dimetil-3-(2-metilprop-1-enil)ciklopropankarboksilat
8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
„607-729-00-9
ATE = 4,63 mg/L (dusts or mists)
mesosulfuron-metil (ISO);
ATE = 500 mg/kg bw
metil 2-[(4,6-dimetoksipirimidin-2-ilkarbamoil)sulfamoil]-α-(metansulfonamido)-p-toluat;
‘607-727-00-8
„607-730-00-4
tetramethrin (ISO);
spirodiklofen (ISO);
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
3-(2,4-diklorofenil)-2-okso-1-oksaspiro[4.5]dec-3-en-4-il 2,2-dimetilbutirat
H371 (nervous system) (inhalation)
„607-731-00-X
‘607-728-00-3
natrijev metil [(4-aminofenil)sulfonil]karbamat; natrijev metil (EZ)-sulfanililkarbonimidat; asulam-natrij
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
„607-732-00-5
‘607-729-00-9
salicilna kislina
mesosulfuron-methyl (ISO);
„608-068-00-9
methyl 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluate;
(2Z)-[2-fluoro-5-(trifluorometil)fenil]tio[3-(2-metoksifenil)-1,3-tiazolidin-2-iliden]acetonitril
‘607-730-00-4
„612-293-00-8
spirodiclofen (ISO);
reakcijska zmes 1-[2-(2-aminobutoksi)etoksi]but-2-ilamina in 1-([2-(2-aminobutoksi)etoksi]metilpropoksi)but-2-ilamina
‘607-731-00-X
2-metilizotiazol-3(2H)-on
sodium methyl [(4-aminophenyl)sulphonyl]carbamate; sodium methyl (EZ)-sulfanilylcarbonimidate; asulam-sodium
„613-327-00-4
‘607-732-00-5
piroksulam (ISO);
salicylic acid
N-(5,7-dimetoksi[1,2,4]triazolo[1,5-a]pirimidin-2-il)-2-metoksi-4-(trifluorometil)piridin-3-sulfonamid
‘608-068-00-9
„613-328-00-X
flutianil (ISO);
1-vinilimidazol
(2Z)-[2-fluoro-5-(trifluoromethyl)phenyl]thio[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene]acetonitrile
1B; H360D: C ≥ 0,03 %“
‘612-293-00-8
„616-224-00-2
reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-([2-(2-aminobutoxy)ethoxy]methylpropoxy)but-2-ylamine
3-(3-bromo-6-fluoro-2-metilindol-1-ilsulfonil)-N,N-dimetil-1H-1,2,4-triazol-1-sulfonamid
‘613-326-00-9
Direktiva Sveta 67/548/EGS in Direktiva 1999/45/ES Evropskega parlamenta in Sveta sta bili razveljavljeni z učinkom od 1. junija 2015.
2-methylisothiazol-3(2H)-one
Zaradi tega je bil del 3 Priloge VI k Uredbi (ES) št. 1272/2008 spremenjen z Uredbo Komisije (EU) 2016/1179 z odstranitvijo tabele 3.2.
‘613-327-00-4
Ta sprememba je začela veljati 1. junija 2017.
N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide
V skladu s členom 2(2) Uredbe (EU) 2017/776 bi se morala večina navedenih sprememb začeti uporabljati od 1. junija 2017, medtem ko je bilo za druge spremembe navedeno, da se začnejo uporabljati od 1. decembra 2018.
‘613-328-00-X
Vendar pa člen 2(2) po pomoti ni navedel dve nadaljnji spremembi, ki bi se morali začeti uporabljati od 1. junija 2017, vključno zlasti s spremembo imena tabele s „tabele 3.1“ na „tabelo 3“.
amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards octyl gallate (E 311) and dodecyl gallate (E 312)
o spremembi prilog II in III k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta ter Priloge k Uredbi Komisije (EU) št. 231/2012 glede oktilgalata (E 311) in dodecilgalata (E 312)
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 10(3) and Article 14 thereof,
ob upoštevanju Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila ter zlasti člena 10(3) in člena 14 Uredbe,
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.
V Prilogi II k Uredbi (ES) št. 1333/2008 so določeni seznam Unije aditivov za živila, odobrenih za uporabo v živilih, in pogoji njihove uporabe.
Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.
V Prilogi III k Uredbi (ES) št. 1333/2008 so določeni seznam Unije aditivov za živila, odobrenih za uporabo v aditivih za živila, encimih za živila, aromah za živila in hranilih, ter pogoji njihove uporabe.
Commission Regulation (EU) No 231/2012 lays down specifications for food additives that are 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.
Octyl gallate (E 311) and dodecyl gallate (E 312) are substances authorised as antioxidants in a variety of foods, as well as in food flavourings, in accordance with Annexes II and III to Regulation (EC) No 1333/2008.
Oktilgalat (E 311) in dodecilgalat (E 312) sta snovi, ki sta odobreni kot antioksidanta v več živilih ter v aromah za živila v skladu s prilogama II in III k Uredbi (ES) št. 1333/2008.
Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the Union before 20 January 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the Authority’).
Člen 32(1) Uredbe (ES) št. 1333/2008 določa, da za vse aditive za živila, ki so bili v Uniji dovoljeni pred 20. januarjem 2009, Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) izvede novo oceno tveganja.
For that purpose, a program for the re-evaluation of food additives is laid down in Commission Regulation (EU) No 257/2010.
V ta namen je v Uredbi Komisije (EU) št. 257/2010 določen program za ponovno oceno aditivov za živila.
Pursuant to Regulation (EU) No 257/2010 the re-evaluation of antioxidants had to be completed by 31 December 2015.
V skladu z Uredbo (EU) št. 257/2010 je bilo treba ponovno oceno antioksidantov zaključiti do 31. decembra 2015.
On 5 May 2015 the Authority delivered a Scientific Opinion on the re-evaluation of dodecyl gallate (E 312) as a food additive.
Agencija je 5. maja 2015 predložila znanstveno mnenje o ponovni oceni dodecilgalata (E 312) kot aditiva za živila.
The opinion stated that there was a lack of adequate toxicological data on dodecyl gallate.
V mnenju je navedla, da ni imela dovolj ustreznih toksikoloških podatkov o dodecilgalatu.
Consequently the Authority was not able to confirm the safety of dodecyl gallate as a food additive and concluded that the present group Acceptable Daily Intake (ADI) for propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) should no longer be valid.
Posledično ni mogla potrditi varnosti dodecilgalata kot aditiva za živila in je navedla, da sedaj veljavni skupinski sprejemljivi dnevni vnos (v nadaljnjem besedilu: ADI) za propilgalat (E 310), oktilgalat (E 311) in dodecilgalat (E 312) ne bi smel več veljati.
The opinion stated that a sufficient toxicological database would be required for an adequate assessment of the safety of dodecyl gallate as a food additive.
V mnenju je navedla, da bi bila za ustrezno oceno varnosti dodecilgalata kot aditiva za živila potrebna zadostna toksikološka zbirka podatkov.
On 1 October 2015 the Authority delivered a Scientific Opinion on the re-evaluation of octyl gallate (E 311) as a food additive.
Agencija je 1. oktobra 2015 predložila znanstveno mnenje o ponovni oceni oktilgalata (E 311) kot aditiva za živila.
The opinion stated that there was a lack of adequate toxicological data on octyl gallate.
V mnenju je navedla, da ni imela dovolj ustreznih toksikoloških podatkov o oktilgalatu.
Consequently the Authority was not able to confirm the safety of octyl gallate as a food additive and concluded that the present group ADI for propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) should no longer be valid.
Posledično ni mogla potrditi varnosti oktilgalata kot aditiva za živila in je navedla, da sedaj veljavni skupinski ADI za propilgalat (E 310), oktilgalat (E 311) in dodecilgalat (E 312) ne bi smel več veljati.
The opinion stated that a sufficient toxicological database would be required for an adequate assessment of the safety of octyl gallate as a food additive.
V mnenju je navedla, da bi bila za ustrezno oceno varnosti oktilgalata kot aditiva za živila potrebna zadostna toksikološka zbirka podatkov.
On 30 May 2017 the Commission launched a public call for scientific and technological data on propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312), targeting the data needs identified in the Scientific Opinions on the re-evaluation of those substances as food additives.
Komisija se je v javnem pozivu z dne 30. maja 2017 za predložitev znanstvenih in tehničnih podatkov o propilgalatu (E 310), oktilgalatu (E 311) in dodecilgalatu (E 312) osredotočila na potrebe po podatkih, opredeljene v znanstvenih mnenjih o ponovni oceni navedenih snovi kot aditivov za živila.
However, no business operator committed to providing the requested toxicological data for octyl gallate (E 311) and dodecyl gallate (E 312).
Vendar noben nosilec dejavnosti ni predložil zahtevanih toksikoloških podatkov za oktilgalat (E 311) in dodecilgalat (E 312).
Without those data the Authority cannot complete the re-evaluation of the safety of octyl gallate and dodecyl gallate as food additives and consequently it cannot be determined whether those substances still fulfil the conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in the Union list of approved food additives.
Brez navedenih podatkov Agencija ne more zaključiti ponovne ocene varnosti oktilgalata in dodecilgalata kot aditivov za živila ter posledično ne more ugotoviti, ali navedeni snovi še vedno izpolnjujeta pogoje iz člena 6(1) Uredbe (ES) št. 1333/2008 za vključitev na seznam Unije odobrenih aditivov za živila.
It is therefore appropriate to remove octyl gallate (E 311) and dodecyl gallate (E 312) from the Union list of approved food additives.
Zato je primerno črtati oktilgalat (E 311) in dodecilgalat (E 312) s seznama Unije odobrenih aditivov za živila.
Pursuant to Article 10(3) of Regulation (EC) No 1333/2008, the Union list of approved food additives shall be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council.
V skladu s členom 10(3) Uredbe (ES) št. 1333/2008 se seznam Unije odobrenih aditivov za živila spremeni v skladu s postopkom iz Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta.
Article 3(1) of Regulation (EC) No 1331/2008 provides that the Union list of food additives may be updated either on the initiative of the Commission or following an application.
V skladu s členom 3(1) Uredbe (ES) št. 1331/2008 se lahko seznam Unije aditivov za živila na pobudo Komisije ali na podlagi zahtevka posodobi.
Therefore, Annexes II and III to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 should be amended by deleting octyl gallate (E 311) and dodecyl gallate (E 312) from the Union list of authorised food additives since due to the absence of appropriate toxicological data their inclusion in the list can no longer be justified.
Prilogi II in III k Uredbi (ES) št. 1333/2008 in Prilogo k Uredbi (EU) št. 231/2012 bi bilo torej treba spremeniti tako, da se oktilgalat (E 311) in dodecilgalat (E 312) črtata s seznama Unije odobrenih aditivov za živila, saj zaradi pomanjkanja ustreznih toksikoloških podatkov njuna vključitev na seznam ni več upravičena.
It is appropriate to provide for a transitional period during which foods containing octyl gallate (E 311) and/or dodecyl gallate (E 312) that have been lawfully placed on the market before the entry in force of this Regulation may continue to be marketed.
Primerno je, da se zagotovi prehodno obdobje, v katerem se lahko živila, ki vsebujejo oktilgalat (E 311) in/ali dodecilgalat (E 312) in so bila zakonito dana na trg pred začetkom veljavnosti te uredbe, še naprej tržijo.
Annexes II and III to Regulation (EC) No 1333/2008 are amended in accordance with the Annex to this Regulation.
Prilogi II in III k Uredbi (ES) št. 1333/2008 se spremenita v skladu s Prilogo k tej uredbi.
In the Annex to Regulation (EU) No 231/2012, the entries for food additives octyl gallate (E 311) and dodecyl gallate (E 312) are deleted.
V Prilogi k Uredbi (EU) št. 231/2012 se vnosa za aditiva za živila oktilgalat (E 311) in dodecilgalat (E 312) črtata.
Foods containing octyl gallate (E 311) and/or dodecyl gallate (E 312) that have been lawfully placed on the market before the entry into force of this Regulation may continue to be marketed until 25 April 2019.
Živila, ki vsebujejo oktilgalat (E 311) in/ali dodecilgalat (E 312) in so bila zakonito dana na trg pred začetkom veljavnosti te uredbe, se lahko še naprej tržijo do 25. aprila 2019.
Done at Brussels, 4 October 2018.
V Bruslju, 4. oktobra 2018
EFSA Journal 2015;13(5):4086.
EFSA Journal 2015, 13(5):4086.
EFSA Journal 2015;13(10):4248.
EFSA Journal 2015, 13(10):4248.
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
Priloga II k Uredbi (ES) št. 1333/2008 se spremeni:
in Part B, in Table 3: Additives other than colours and sweeteners, the entries for the food additives E 311 octyl gallate and E 312 dodecyl gallate are deleted;
v delu B preglednice 3 (Aditivi razen barvil in sladil) se vnosa za aditiva za živila oktilgalat (E 311) in dodecilgalat (E 312) črtata;