Commission Regulation (EU) 2018/678 of 3 May 2018 amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (Text with EEA relevance. )
Commission Regulation (EU) 2018/678of 3 May 2018amending and correcting Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,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/ECOJ L 354, 31.12.2008, p. 34., and in particular Article 11(3) thereof,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 flavouringsOJ L 354, 31.12.2008, p. 1., and in particular Article 7(5) thereof,Whereas:(1)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.(2)Commission Implementing Regulation (EU) No 872/2012Commission 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). adopted the list of flavouring substances and introduced it as Part A of Annex I to Regulation (EC) No 1334/2008.(3)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.(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. Those substances were listed as flavouring substances under evaluation in 2012. They have now been assessed by the Authority in the following flavouring group evaluations: evaluation FGE.72rev1EFSA Journal 2013;11(10):3392 (substance with FL-No 09.931), evaluation FGE.21rev4EFSA Journal 2013;11(11):3451 (substances with FL-Nos 15.057 and 15.079), evaluation FGE.76rev1EFSA Journal 2013;11(11):3455 (substances with FL-Nos 15.004, 15.109 and 15.113), evaluations FGE.94EFSA Journal 2010; 8(5):1338 and FGE.94rev.2EFSA Journal 2014;12(4):3622 (substance with FL-No 16.090), evaluations FGE.94rev.1EFSA Journal 2012;10(6):2747 and FGE94rev.2EFSA Journal 2014;12(4):3622 (substance with FL-No 16.111), and evaluation FGE.67rev2EFSA Journal 2015; 13(5):4115 (substance with FL-No 13.058). The Authority concluded that those flavouring substances do not give rise to safety concerns at the estimated levels of dietary intakes.(5)Therefore, those flavouring substances should be listed as evaluated substances and the footnote references 1 to 4 should be deleted from the entries concerned.(6)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. Those errors should be corrected.(7)Part A of Annex I to Regulation (EC) No 1334/2008 should be amended and corrected accordingly.(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION:
Article 1Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.
Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 3 May 2018.For the CommissionThe PresidentJean-Claude JunckerANNEXSection 2 of Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:(1)The entry concerning FL-No 09.931 is replaced by the following:
"09.9312,6-Dimethyl-2,5,7-octatriene-1-ol acetate999999-91-41226EFSA"
(2)The entry concerning FL-No 12.054 is replaced by the following:
"12.0542-Ethylthiophenol4500-58-752911666JECFA"
(3)The entry concerning FL-No 13.058 is replaced by the following:
"13.0583-(5-Methyl-2-furyl) butanal31704-80-0150010355EFSA"
(4)The entry concerning FL-No 15.004 is replaced by the following:
"15.0045-Methyl-2-thiophenecarbaldehyde13679-70-410502203EFSA"
(5)The entry concerning FL-No 15.057 is replaced by the following:
"15.0574,6-Dimethyl-2-(1-methylethyl)dihydro-1,3,5-dithiazine104691-40-9At 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-dithiazineEFSA"
(6)The entry concerning FL-No 15.079 is replaced by the following:
"15.0792-Isobutyldihydro-4,6- dimethyl-1,3,5- dithiazine101517-87-7At 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-thiadiazineEFSA"
(7)The entry concerning FL-No 15.109 is replaced by the following:
"15.1092,4,6-Trimethyldihydro-1,3,5(4H)- dithiazine638-17-5104911649EFSA"
(8)The entry concerning FL-No 15.113 is replaced by the following:
"15.1135,6-Dihydro-2,4,6- tris(2-methylpropyl)4H-1,3,5-dithiazine74595-94-11048EFSA"
(9)The entry concerning FL-No 16.090 is replaced by the following:
"16.0903-(3,4-Dimethoxyphenyl)-N-[2-(3,4-dimethoxyphenyl)-ethyl]- acrylamide69444-90-21777EFSA"
(10)The entry concerning FL-No 16.111 is replaced by the following:
"16.111Glycine, N- [[(1R,2S,5R)-5-methyl- 2-(1-methylethyl)cyclohexyl]carbonyl]-, ethyl ester.68489-14-51776EFSA"
(11)The entry concerning FL-No 17.038 is replaced by the following:
"17.038gamma-Glutamyl-valyl-glycine38837-70-621235-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)Restrictions for use as a flavouring substance:In category 1 — not more than 50 mg/kgIn categories 2 and 5 — not more than 60 mg/kgIn category 6.3, breakfast cereals — not more than 160 mg/kgIn category 7.2 — not more than 60 mg/kgIn category 8 — not more than 45 mg/kgIn category 12 — not more than 160 mg/kgIn category 14.1 — not more than 15 mg/kgIn category 15 — not more than 160 mg/kgEFSA"