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Document 32013R0985

    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

    IO L 273, 15.10.2013, p. 18–24 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg/2013/985/oj

    15.10.2013   

    EN

    Official Journal of the European Union

    L 273/18


    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 1

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

    Article 2

    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


    (1)   OJ L 354, 31.12.2008, p. 34.

    (2)   OJ L 354, 31.12.2008, p. 1.

    (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.


    ANNEX

    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-ol

    35854-86-5

    324

    10294

     

     

     

    JECFA’

    (2)

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

    ‘02.110

    2,6-Dimethylhept-6-en-1-ol

    36806-46-9

    348

     

    At least 90 %; secondary component 5-10 % 2,6-dimethyl-5-hepten-1-ol

     

     

    JECFA’

    (3)

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

    ‘02.145

    2,6-Dimethylocta-1,5,7-trien-3-ol

    29414-56-0

     

     

     

     

     

    EFSA’

    (4)

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

    ‘02.194

    Octa-1,5-dien-3-ol

    83861-74-9

     

     

     

     

     

    EFSA’

    (5)

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

    ‘02.211

    Undeca-1,5-dien-3-ol

    56722-23-7

     

     

     

     

     

    EFSA’

    (6)

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

    ‘02.229

    (-)-3,7-Dimethyl-6-octen-1-ol

    7540-51-4

     

     

    At least 90 % cis-isomer; secondary components 2-6 % di-unsaturated and saturated C10 alcohols, 2-4 % citronellyl acetate and 2-3 % citronellal

     

     

    EFSA’

    (7)

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

    ‘02.252

    4,8-Dimethyl-3,7-nonadien-2-ol

    67845-50-5

    1841

     

     

     

     

    EFSA’

    (8)

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

    ‘05.026

    o-Tolualdehyde

    529-20-4

     

     

     

     

     

    EFSA’

    (9)

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

    ‘05.028

    m-Tolualdehyde

    620-23-5

     

     

     

     

     

    EFSA’

    (10)

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

    ‘05.029

    p-Tolualdehyde

    104-87-0

     

     

     

     

     

    EFSA’

    (11)

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

    ‘05.085

    (Z)-Hept-4-enal

    6728-31-0

    320

    2124

    At 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:

    ‘05.137

    Dec-4(cis)-enal

    21662-09-9

     

     

    At least 90 %; secondary component at least 5 % trans-isomer

     

     

    EFSA’

    (13)

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

    ‘05.182

    2,6,6-Trimethylcyclohex-2-ene-1-carboxaldehyde

    432-24-6

     

     

     

     

     

    EFSA’

    (14)

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

    ‘07.190

    Octa-1,5-dien-3-one

    65213-86-7

    1848

     

    Mixture of stereoisomers: 60-90 % E-form and 10-40 % Z-form

     

     

    EFSA’

    (15)

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

    ‘07.198

    Pseudo-ionone

    141-10-6

     

    11191

     

     

     

    EFSA’

    (16)

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

    ‘07.202

    2,6,6-Trimethylcyclohex-2-en-1-one

    20013-73-4

     

     

     

     

     

    EFSA’

    (17)

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

    ‘07.204

    3,3,6-Trimethylhepta-1,5-dien-4-one

    546-49-6

     

     

     

     

     

    EFSA’

    (18)

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

    ‘07.255

    l-Piperitone

    4573-50-6

    1856

     

     

     

     

    EFSA’

    (19)

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

    ‘08.004

    Lactic acid

    50-21-5

    930

    4

     

     

     

    EFSA’

    (20)

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

    ‘09.016

    Menthyl acetate

    16409-45-3

    431

    206

     

     

     

    JECFA’

    (21)

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

    ‘09.131

    DL-Isobornyl propionate

    2756-56-1

    1391

    412

     

     

     

    EFSA’

    (22)

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

    ‘09.132

    Benzyl propionate

    122-63-4

    842

    413

     

     

     

    EFSA’

    (23)

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

    ‘09.266

    Hexyl 2-butenoate

    19089-92-0

    1807

    10688

     

     

     

    EFSA’

    (24)

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

    ‘09.562

    trans-3-Hexenyl formate

    56922-80-6

     

     

     

     

     

    EFSA’

    (25)

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

    ‘09.578

    Hexyl (E)-but-2-enoate

    1617-25-0

     

    10688

     

     

     

    EFSA’

    (26)

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

    ‘09.596

    Isopentyl-(Z)-but-2-enoate

    10482-55-0

     

     

     

     

     

    EFSA’

    (27)

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

    ‘09.854

    cis-3-Hexenyl 2-methylbutanoate

    53398-85-9

     

     

     

     

     

    EFSA’

    (28)

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

    ‘09.858

    Phenylmethyl 2-methyl-2-butenoate

    67674-41-3

     

     

    Mixture of stereoisomers: 60-90 % E-form and 10-40 % Z-form

     

     

    EFSA’

    (29)

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

    ‘09.880

    (Z)-Hept-4-en-2-yl butanoate

    94088-12-7

     

     

     

     

     

    EFSA’

    (30)

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

    ‘09.936

    4,8-Dimethyl-3,7-nonadien-2-yl acetate

    91418-25-6

    1847

     

     

     

     

    EFSA’

    (31)

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

    ‘12.075

    Methyl prop-1-enyl disulfide

    5905-47-5

    569

    11712

    At least 90 %; secondary components 3-4 % dimethyl disulfide and 3-4 % di-1-propenyl disulfide

     

     

    JECFA’

    (32)

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

    ‘12.086

    S-Methyl 2-methylbutanethioate

    42075-45-6

    486

     

     

     

     

    JECFA’

    (33)

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

    ‘12.273

    3-(Methylthio)heptanal

    51755-70-5

    1692

     

    At least 92 %; secondary component 5-7 % (E)-hept-2-enal

     

     

    EFSA’

    (34)

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

    ‘13.028

    2-Butyl-5 or 6-keto-1,4-dioxane

    65504-95-2

    1484

    2206

     

     

     

    EFSA’

    (35)

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

    ‘13.170

    2S-cis-Tetrahydro-4-methyl-2-(2-methyl-1-propenyl)-2H-pyran

    3033-23-6

     

     

     

     

     

    EFSA’

    (36)

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

    ‘13.190

    3-((2-methyl-3-furyl)thio)-2-butanone

    61295-44-1

    1525

     

     

     

     

    EFSA’

    (37)

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

    ‘14.067

    2-Ethoxy-3-methylpyrazine

    32737-14-7

    793

    11921

    At 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:

    ‘15.134

    2,5-Dihydroxy-1,4-dithiane

    40018-26-6

    550

     

    Mixture 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:

    ‘16.095

    Cyclopropanecarboxamide, N-[(2E)-3,7-dimethyl-2,6-octadien-1-yl]-

    744251-93-2

    1779

     

     

     

     

    EFSA’

    (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)cyclohexanecarboxamide

    68489-09-8

     

     

     

     

     

    EFSA’

    (41)

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

    ‘17.015

    DL-Methylmethioninesulphonium chloride

    3493-12-7

    1427

    761

     

     

     

    EFSA’


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