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Commission Regulation (EU) No 985/2013

of 14 October 2013

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)

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/EC(1), 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 flavourings(2), 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) Part A of the Union list contains both evaluated flavouring substances, which are assigned no footnotes and flavourings substances under evaluation, which are identified by footnote references 1 to 4 in that list.

(3) The European Food Safety Authority has completed the assessment of 23 substances which are currently listed as flavouring substances under evaluation. Those flavouring substances were assessed by the EFSA in the following flavouring group evaluations: evaluation FGE.06rev4(3) (substances FL Nos 02.229, 05.137, 09.562 and 09.854), evaluation FGE.07rev4(4) (substances FL Nos 02.145, 02.194, 02.211, 07.198 and 07.204), evaluation FGE.08rev5(5) (substance FL No 15.134), evaluation FGE.09rev4(6) (substances FL Nos 07.202 and 07.255), evaluation FGE.12rev3(7) (substance FL No 05.182), evaluation FGE.20rev4(8) (substances FL Nos 05.026, 05.028, 05.029 and 09.858), evaluation in FGE.23rev4(9) (substance FL No 13.170), evaluation in FGE.63rev1(10) (substances FL Nos 02.252, 07.190 and 09.936), evaluation FGE.94rev1(11) (substance FL No 16.095) and evaluation FGE.304(12) (substance FL No 16.123). The EFSA concluded that those flavouring substances do not give rise to safety concerns at the estimated levels of dietary intakes.

(4) Therefore, the flavouring substances assessed in those flavouring group evaluations should be listed as evaluated substances by deleting footnote references 1 to 4 in the relevant entries of the Union list.

(5) After publication of the Union list, certain errors have been identified in that list. Those errors are related to names, CAS-numbers, JECFA-numbers or secondary components of the followings substances: FL Nos 02.093, 02.110, 05.085, 08.004, 09.016, 09.131, 09.132, 09.266, 09.578, 09.596, 09.880, 12.075, 12.086, 12.273, 13.028, 13.190, 14.067 and 17.015. The errors should be corrected.

(6) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended and corrected accordingly.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1U.K.

Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2U.K.

This 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, 14 October 2013.

For the Commission

The President

José Manuel Barroso

ANNEXU.K.

Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:

(1)

the entry concerning FL No 02.093 is replaced by the following:

02.093(Z)-Non-6-en-1-ol35854-86-532410294JECFA
(2)

the entry concerning FL No 02.110 is replaced by the following:

02.1102,6-Dimethylhept-6-en-1-ol36806-46-9348At least 90 %; secondary component 5-10 % 2,6-dimethyl-5-hepten-1-olJECFA
(3)

the entry concerning FL No 02.145 is replaced by the following:

02.1452,6-Dimethylocta-1,5,7-trien-3-ol29414-56-0EFSA
(4)

the entry concerning FL No 02.194 is replaced by the following:

02.194Octa-1,5-dien-3-ol83861-74-9EFSA
(5)

the entry concerning FL No 02.211 is replaced by the following:

02.211Undeca-1,5-dien-3-ol56722-23-7EFSA
(6)

the entry concerning FL No 02.229 is replaced by the following:

02.229(-)-3,7-Dimethyl-6-octen-1-ol7540-51-4At least 90 % cis-isomer; secondary components 2-6 % di-unsaturated and saturated C10 alcohols, 2-4 % citronellyl acetate and 2-3 % citronellalEFSA
(7)

the entry concerning FL No 02.252 is replaced by the following:

02.2524,8-Dimethyl-3,7-nonadien-2-ol67845-50-51841EFSA
(8)

the entry concerning FL No 05.026 is replaced by the following:

05.026o-Tolualdehyde529-20-4EFSA
(9)

the entry concerning FL No 05.028 is replaced by the following:

05.028m-Tolualdehyde620-23-5EFSA
(10)

the entry concerning FL No 05.029 is replaced by the following:

05.029p-Tolualdehyde104-87-0EFSA
(11)

the entry concerning FL No 05.085 is replaced by the following:

05.085(Z)-Hept-4-enal6728-31-03202124At least 93 % of Z-form of hept-4-enal; secondary component 2-5 % of E-form of hept-4-enal.JECFA
(12)

the entry concerning FL No 05.137 is replaced by the following:

05.137Dec-4(cis)-enal21662-09-9At least 90 %; secondary component at least 5 % trans-isomerEFSA
(13)

the entry concerning FL No 05.182 is replaced by the following:

05.1822,6,6-Trimethylcyclohex-2-ene-1-carboxaldehyde432-24-6EFSA
(14)

the entry concerning FL No 07.190 is replaced by the following:

07.190Octa-1,5-dien-3-one65213-86-71848Mixture of stereoisomers: 60-90 % E-form and 10-40 % Z-formEFSA
(15)

the entry concerning FL No 07.198 is replaced by the following:

07.198Pseudo-ionone141-10-611191EFSA
(16)

the entry concerning FL No 07.202 is replaced by the following:

07.2022,6,6-Trimethylcyclohex-2-en-1-one20013-73-4EFSA
(17)

the entry concerning FL No 07.204 is replaced by the following:

07.2043,3,6-Trimethylhepta-1,5-dien-4-one546-49-6EFSA
(18)

the entry concerning FL No 07.255 is replaced by the following:

07.255l-Piperitone4573-50-61856EFSA
(19)

the entry concerning FL No 08.004 is replaced by the following:

08.004Lactic acid50-21-59304EFSA
(20)

the entry concerning FL No 09.016 is replaced by the following:

09.016Menthyl acetate16409-45-3431206JECFA
(21)

the entry concerning FL No 09.131 is replaced by the following:

09.131DL-Isobornyl propionate2756-56-11391412EFSA
(22)

the entry concerning FL No 09.132 is replaced by the following:

09.132Benzyl propionate122-63-4842413EFSA
(23)

the entry concerning FL No 09.266 is replaced by the following:

09.266Hexyl 2-butenoate19089-92-0180710688EFSA
(24)

the entry concerning FL No 09.562 is replaced by the following:

09.562trans-3-Hexenyl formate56922-80-6EFSA
(25)

the entry concerning FL No 09.578 is replaced by the following:

09.578Hexyl (E)-but-2-enoate1617-25-010688EFSA
(26)

the entry concerning FL No 09.596 is replaced by the following:

09.596Isopentyl-(Z)-but-2-enoate10482-55-0EFSA
(27)

the entry concerning FL No 09.854 is replaced by the following:

09.854cis-3-Hexenyl 2-methylbutanoate53398-85-9EFSA
(28)

the entry concerning FL No 09.858 is replaced by the following:

09.858Phenylmethyl 2-methyl-2-butenoate67674-41-3Mixture of stereoisomers: 60-90 % E-form and 10-40 % Z-formEFSA
(29)

the entry concerning FL No 09.880 is replaced by the following:

09.880(Z)-Hept-4-en-2-yl butanoate94088-12-7EFSA
(30)

the entry concerning FL No 09.936 is replaced by the following:

09.9364,8-Dimethyl-3,7-nonadien-2-yl acetate91418-25-61847EFSA
(31)

the entry concerning FL No 12.075 is replaced by the following:

12.075Methyl prop-1-enyl disulfide5905-47-556911712At least 90 %; secondary components 3-4 % dimethyl disulfide and 3-4 % di-1-propenyl disulfideJECFA
(32)

the entry concerning FL No 12.086 is replaced by the following:

12.086S-Methyl 2-methylbutanethioate42075-45-6486JECFA
(33)

the entry concerning FL No 12.273 is replaced by the following:

12.2733-(Methylthio)heptanal51755-70-51692At least 92 %; secondary component 5-7 % (E)-hept-2-enalEFSA
(34)

the entry concerning FL No 13.028 is replaced by the following:

13.0282-Butyl-5 or 6-keto-1,4-dioxane65504-95-214842206EFSA
(35)

the entry concerning FL No 13.170 is replaced by the following:

13.1702S-cis-Tetrahydro-4-methyl-2-(2-methyl-1-propenyl)-2H-pyran3033-23-6EFSA
(36)

the entry concerning FL No 13.190 is replaced by the following:

13.1903-((2-methyl-3-furyl)thio)-2-butanone61295-44-11525EFSA
(37)

the entry concerning FL No 14.067 is replaced by the following:

14.0672-Ethoxy-3-methylpyrazine32737-14-779311921At least 82 % 2-ethoxy-3-methylpyrazine. Secondary components 15 % 2–ethoxy-5-methylpyrazine (CAS no 67845-34-5) or 2-ethoxy-6-methylpyrazine (CAS no 53163-97-6)EFSA
(38)

the entry concerning FL No 15.134 is replaced by the following:

15.1342,5-Dihydroxy-1,4-dithiane40018-26-6550Mixture of diastereoisomers: 25-30 % of (2S,5S and 2R,5R) and 70-75 % (2S,5R and 2R,5S)EFSA
(39)

the entry concerning FL No 16.095 is replaced by the following:

16.095Cyclopropanecarboxamide, N-[(2E)-3,7-dimethyl-2,6-octadien-1-yl]-744251-93-21779EFSA
(40)

the entry concerning FL No 16.123 is replaced by the following:

16.123(1R,2S,5R)-N-(4-Methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexanecarboxamide68489-09-8EFSA
(41)

the entry concerning FL No 17.015 is replaced by the following:

17.015DL-Methylmethioninesulphonium chloride3493-12-71427761EFSA
(3)

EFSA Journal 2013; 11(2):3091.

(4)

EFSA Journal 2012; 10(10):2899.

(5)

EFSA Journal 2012; 10(7):2837.

(6)

EFSA Journal 2012; 10(7):2836.

(7)

EFSA Journal 2012; 10(12):2993.

(8)

EFSA Journal 2012; 10(12):2994.

(9)

EFSA Journal 2013; 11(2):3092.

(10)

EFSA Journal 2012; 10(10):2900.

(11)

EFSA Journal 2012; 10(6):2747.

(12)

EFSA Journal 2012; 10(10):2903.