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Annex I - ▼M2

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UNION LIST OF FLAVOURINGS AND SOURCE MATERIALS

PART A

Union list of flavouring substances

SECTION 1

Content of the list

Table 1 contains the following information:

Column 1 (FL No.): the unique identification number of the substance

Column 2 (Chemical Name): the name of the substance

Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number

Column 4 (JECFA No.): The Joint FAO/WHO Expert Committee on Food additives (JECFA) number

Column 5 (CoE No.): The Council of Europe (CoE) number

Column 6 (Purity of the named substance at least 95% unless otherwise specified): The purity of the named flavouring substance has to be at least 95%. If less, the composition of the flavouring substances is given in this column.

Column 7 (Restrictions of Use): The use of flavouring substances is permitted in accordance with good manufacturing practices unless specific restriction is given in this column. Flavouring substances with restrictions of use may only be added to the listed food categories and under the specified conditions of use. For the purpose of the restrictions the following food categories, as laid down in Annex II of Regulation (EC) No 1333/2008, shall be referred to:

Category number | Food category

1 | Dairy products and analogues

2 | Fats and oils and fat and oil emulsions

3 | Edible ices

4.2 | Processed fruit and vegetables

5 | Confectionery

5.3 | Chewing gum

6 | Cereals and cereal products

7 | Bakery wares

8 | Meat

9 | Fish and fisheries products

10 | Eggs and egg products

11 | Sugars, syrups, honey and table-top sweeteners

12 | Salts, spices, soups, sauces, salads and protein products

13 | Food intended for particular nutritional uses as defined by Directive 2009/39/EC (1)

14.1 | Non-alcoholic beverages

14.2 | Alcoholic beverages, including alcohol-free and low-alcoholic counterparts

15 | Ready-to-eat savouries and snacks

16 | Desserts excluding products covered in category 1, 3 and 4

17 | Food supplements as defined in Directive 2002/46/EC (2) of the European Parliament and of the Council excluding food supplements for infants and young children

18 | Processed food not covered by categories 1-17, excluding foods for infants and young children

(1) OJ L 124, 20.5.2009, p. 21. (2) OJ L 183, 12.7.2002, p. 51.

Column 8 (Footnotes): The footnote ‘1’ is allocated to the flavouring substances for which the evaluation has to be completed by the Authority. The footnotes ‘2’ to ‘4’ refer to time limits set for the applicants to comply with the Authority's requests as expressed in the published opinions. Where the necessary information is not provided by the time requested, the flavouring substance in question will be withdrawn from the Union list. The Authority shall evaluate the submitted data within 9 months from the receipt of such data. Substances which have already been evaluated by JECFA can be recognised from the JECFA number listed in column 4.

(1) evaluation to be completed by the Authority

(2) additional scientific data shall be submitted by 31 December 2012

(3) additional scientific data shall be submitted by 30 June 2013

(4) additional scientific data shall be submitted by 31 December 2013

Column 9 (Reference): Reference to the scientific body that has carried out the evaluation.

SECTION 2

Notes

Note 1: Ammonium, sodium, potassium and calcium salts as well as chlorides, carbonates and sulphates are covered by the generic substances, providing that they have flavouring properties.

Note 2: If the authorised flavouring substance is a racemate (an equal mixture of optical isomers), both the R- and S- form shall also be authorised for use. If only the R-form has been authorised then the S-form is not covered by this authorisation and vice versa.

Note 3: Maximum levels refer to levels in or on food as marketed. By way of derogation from that principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions in the labelling taking into account the minimum dilution factor.

Note 4: The presence of a flavouring substance shall be permitted:

(a) in a compound food other than as referred to in the Annex, where the flavouring substance is permitted in one of the ingredients of the compound food;

(b) in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation.

Table 1

(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9)

FL No. | Chemical Name | CAS No. | JECFA No. | CoE No. | Purity of the named substance at least 95% unless otherwise specified | Restrictions of Use | Footnote | Reference

01.001 | Limonene | 138-86-3 | | 491 | | | | EFSA

01.002 | 1-Isopropyl-4-methylbenzene | 99-87-6 | 1325 | 620 | | | | EFSA

01.003 | Pin-2(10)-ene | 127-91-3 | 1330 | 2114 | | | 2 | EFSA

01.004 | Pin-2(3)-ene | 80-56-8 | 1329 | 2113 | | | 2 | EFSA

01.005 | Terpinolene | 586-62-9 | 1331 | 2115 | | | | EFSA

01.006 | alpha-Phellandrene | 99-83-2 | 1328 | 2117 | At least 85%; secondary components 10-12% cymene and other terpene hydrocarbons | | | EFSA

01.007 | beta-Caryophyllene | 87-44-5 | 1324 | 2118 | 80-92% beta-caryophyllene and 15-19% C15H24 terpene hydrocarbons (eg. valencene) | | 2 | EFSA

01.008 | Myrcene | 123-35-3 | 1327 | 2197 | At least 90%; secondary components C15H24 terpene hydrocarbons (eg. valencene); Minimum assay value may include traces of limonene, alpha- and beta-pinene and other common C10H16 terpenes. | | 4 | EFSA

01.009 | Camphene | 79-92-5 | 1323 | 2227 | At least 80%; secondary components 15-19% C15H24 terpene hydrocarbons (eg. valencene) | | 2 | EFSA

01.010 | 1-Isopropenyl-4-methylbenzene | 1195-32-0 | 1333 | 2260 | | | | EFSA

▼M9 —————

▼M5 —————

▼M2

01.016 | 1,4(8),12-Bisabolatriene | 495-62-5 | 1336 | 10979 | | | | EFSA

01.017 | Valencene | 4630-07-3 | 1337 | 11030 | At least 94%; secondary components 1-4% other C15H24 sesquiterpenes | | 2 | EFSA

01.018 | beta-Ocimene | 13877-91-3 | 1338 | 11015 | At least 80%; secondary component 15-17% cis-beta-ocimene | | 4 | EFSA

01.019 | alpha-Terpinene | 99-86-5 | 1339 | 11023 | At least 89%; secondary components 6-7% 1,4- and 1,8-cineole | | | EFSA

01.020 | gamma-Terpinene | 99-85-4 | 1340 | 11025 | | | | EFSA

01.024 | beta-Bourbonene | 5208-59-3 | 1345 | 11931 | | | 2 | EFSA

01.026 | 1(5),7(11)-Guaiadiene | 88-84-6 | 1347 | | | | 2 | EFSA

01.027 | Bisabola-1,8,12-triene | 17627-44-0 | | | | | | EFSA

01.028 | beta-Bisabolene | 495-61-4 | | | | | | EFSA

01.029 | delta-3-Carene | 13466-78-9 | 1342 | 10983 | At least 92%; secondary components 2-3% beta-pinene; 1-2% limonene; 1-2% myrcene; 0-1% p-cymene | | 2 | EFSA

01.033 | 2,2-Dimethylhexane | 590-73-8 | | | | | | EFSA

01.034 | 2,4-Dimethylhexane | 589-43-5 | | | | | | EFSA

01.035 | 2,6-Dimethylocta-2,4,6-triene | 673-84-7 | | | | | 2 | EFSA

01.038 | Dodecane | 112-40-3 | | | | | | EFSA

01.039 | delta-Elemene | 20307-84-0 | | 10996 | | | | EFSA

01.040 | alpha-Farnesene | 502-61-4 | 1343 | 10998 | At least 38% alpha and 29% beta (sum of cis/trans isomers); secondary components 20% bisabolene, up to 10% other isomers (valencene, bourbonene, cadinene, guaiene) | | 4 | EFSA

01.045 | d-Limonene | 5989-27-5 | 1326 | 491 | | | | EFSA

01.046 | l-Limonene | 5989-54-8 | | 491 | | | | EFSA

01.054 | Pentadecane | 629-62-9 | | | | | | EFSA

01.057 | Tetradecane | 629-59-4 | | | | | | EFSA

01.059 | 4(10)-Thujene | 3387-41-5 | | 11018 | | | 2 | EFSA

01.061 | Undeca-1,3,5-triene | 16356-11-9 | 1341 | | At least 94% (sum of cis/trans isomers); secondary component 2,4,6-undecatriene (Z,Z,E) | | 4 | EFSA

01.064 | cis-3,7-Dimethyl-1,3,6-octatriene | 3338-55-4 | | | | | 2 | EFSA

01.070 | 1-Octene | 111-66-0 | | | | | 2 | EFSA

01.077 | 1-Methyl-1,3-cyclohexadiene | 1489-56-1 | 1344 | | | | | EFSA

02.001 | 2-Methylpropan-1-ol | 78-83-1 | 251 | 49 | | | | JECFA

02.002 | Propan-1-ol | 71-23-8 | 82 | 50 | | | | JECFA

02.003 | Isopentanol | 123-51-3 | 52 | 51 | | | | JECFA

02.004 | Butan-1-ol | 71-36-3 | 85 | 52 | | | | JECFA

02.005 | Hexan-1-ol | 111-27-3 | 91 | 53 | | | | JECFA

02.006 | Octan-1-ol | 111-87-5 | 97 | 54 | | | | JECFA

02.007 | Nonan-1-ol | 143-08-8 | 100 | 55 | | | | JECFA

02.008 | Dodecan-1-ol | 112-53-8 | 109 | 56 | | | | JECFA

02.009 | Hexadecan-1-ol | 36653-82-4 | 114 | 57 | | | | JECFA

02.010 | Benzyl alcohol | 100-51-6 | 25 | 58 | | | | EFSA

02.011 | Citronellol | 106-22-9 | 1219 | 59 | At least 90%; secondary components 5-8% di-unsaturated and saturated C10 alcohols, 1% citronellyl acetate, 1% citronellal | | | EFSA

02.012 | Geraniol | 106-24-1 | 1223 | 60 | | | | EFSA

02.013 | Linalool | 78-70-6 | 356 | 61 | | | | JECFA

02.014 | alpha-Terpineol | 98-55-5 | 366 | 62 | | | | JECFA

02.015 | Menthol | 89-78-1 | 427 | 63 | | | | JECFA

02.016 | DL-Borneol | 507-70-0 | 1385 | 64 | | | | EFSA

02.017 | Cinnamyl alcohol | 104-54-1 | 647 | 65 | | | | EFSA

02.018 | Nerolidol | 7212-44-4 | 1646 | 67 | | | | EFSA

02.019 | 2-Phenylethan-1-ol | 60-12-8 | 987 | 68 | | | | EFSA

02.020 | Hex-2-en-1-ol | 2305-21-7 | 1354 | | | | 2 | EFSA

02.021 | Heptan-1-ol | 111-70-6 | 94 | 70 | | | | JECFA

02.022 | Octan-2-ol | 123-96-6 | 289 | 71 | | | | JECFA

02.023 | Oct-1-en-3-ol | 3391-86-4 | 1152 | | | | 1 | EFSA

02.024 | Decan-1-ol | 112-30-1 | 103 | 73 | | | | JECFA

02.026 | 3,7-Dimethyloctan-1-ol | 106-21-8 | 272 | 75 | At least 90%; secondary components 5-7% geraniol and citronellol | | | JECFA

02.027 | (-)-Rhodinol | 6812-78-8 | 1222 | 76 | | | | EFSA

02.028 | 3,7-Dimethyloctan-3-ol | 78-69-3 | 357 | 77 | | | | JECFA

02.029 | 3,7,11-Trimethyldodeca-2,6,10-trien-1-ol | 4602-84-0 | 1230 | 78 | | | | EFSA

02.030 | alpha-Pentylcinnamyl alcohol | 101-85-9 | 674 | 79 | | | | EFSA

02.031 | 3-Phenylpropan-1-ol | 122-97-4 | 636 | 80 | | | | EFSA

02.033 | 1-Phenylpropan-1-ol | 93-54-9 | 822 | 82 | | | | EFSA

02.034 | 1-Phenylpentan-2-ol | 705-73-7 | 825 | 83 | | | | EFSA

02.035 | 2-Methyl-1-phenylpropan-2-ol | 100-86-7 | 1653 | 84 | | | | EFSA

02.036 | 4-Phenylbutan-2-ol | 2344-70-9 | 815 | 85 | | | | EFSA

02.037 | 3-Methyl-1-phenylpentan-3-ol | 10415-87-9 | 1649 | 86 | | | | EFSA

02.038 | Fenchyl alcohol | 1632-73-1 | 1397 | 87 | | | | EFSA

02.039 | 4-Isopropylbenzyl alcohol | 536-60-7 | 864 | 88 | | | | EFSA

02.040 | Pentan-1-ol | 71-41-0 | 88 | 514 | | | | JECFA

02.041 | 2-Methylbutan-2-ol | 75-85-4 | | 515 | | | | EFSA

02.042 | 2-(4-Methylphenyl)propan-2-ol | 1197-01-9 | 1650 | 530 | At least 90%; secondary component 9-11% p-isopropenyltoluene | | | EFSA

02.043 | 2-Ethylbutan-1-ol | 97-95-0 | | 543 | | | | SCF/CoE

02.044 | Heptan-3-ol | 589-82-2 | 286 | 544 | | | | JECFA

02.045 | Heptan-2-ol | 543-49-7 | 284 | 554 | | | | JECFA

02.047 | 3,7-Dimethyloctane-1,7-diol | 107-74-4 | 610 | 559 | | | | JECFA

02.049 | Nona-2,6-dien-1-ol | 7786-44-9 | 1184 | 589 | | | 2 | EFSA

02.050 | Pent-2-en-1-ol | 20273-24-9 | 1793 | 665 | | | 2 | EFSA

02.051 | 5-Phenylpentan-1-ol | 10521-91-2 | 675 | 674 | | | | EFSA

02.052 | 2-Methylpropan-2-ol | 75-65-0 | | 698 | | | | EFSA

02.054 | p-Menthane-1,8-diol | 80-53-5 | | 701 | | | | EFSA

02.055 | 3,5,5-Trimethylhexan-1-ol | 3452-97-9 | 268 | 702 | | | | JECFA

02.056 | Hex-3(cis)-en-1-ol | 928-96-1 | 315 | 750c | | | | JECFA

02.057 | Undecan-1-ol | 112-42-5 | 106 | 751 | | | | JECFA

02.058 | (Z)-Nerol | 106-25-2 | 1224 | 2018 | | | | EFSA

02.059 | DL-Isoborneol | 124-76-5 | 1386 | 2020 | At least 92%; secondary component 3-5% borneol | | | EFSA

▼M16

02.060 | p-Mentha-1,8-dien-7-ol | 536-59-4 | 974 | 2024 | | In categories 1, 3, 4.2, 5 (except category 5.3), 6, 7, 14.1, 14.2 and 16 | 1 | EFSA

▼M2

02.061 | Dihydrocarveol | 619-01-2 | 378 | 2025 | | | | JECFA

02.062 | Carveol | 99-48-9 | 381 | 2027 | | | | JECFA

02.063 | d-Neomenthol | 2216-52-6 | 428 | 2028 | | | | JECFA

PART B

Flavouring preparations

PART C

Thermal process flavourings

PART D

Flavour precursors

PART E

Other flavourings

FL no. | Name | CAS no | JECFA No. | CoE No. | Purity of the named flavouring | Restrictions of use | Footnote | Reference

21.001 | Pyroligneous distillate | — | — | — | Complex mixture of substances, obtained by distillation of reaction products of pyroligneous acid and ethanol. Liquid with rum-like tasting odour and taste. Constituents: — Ethanol (determined by Gas Chromatography/Flame Ionization Detector): more than 40 % w/w) — Ethyl acetate: less than 25 % w/w) — Ethyl formate: less than 2 % w/w) — Ethyl propionate: less than 4 % w/w) — Ethyl butyrate: less than 1,5 % w/w) — Methyl acetate: less than 3,5 % w/w) — Furan equivalents (furan and 2 methyl furan) expressed as furan: less than 8 mg/l — Methanol and methanol derivatives, expressed as methanol equivalents: less than 2 % (w/w) — Benzopyrene: less than 1 μg/l — Benz(a)anthra-cene: less than 2 μg/l — acids (expressed as acetic acid): less than 1,00 g/l | In the following spirit drinks only: tuzemák and tuzemský falling under Regulation (EC) No 110/2008 when marketed in the final package intended only for the final consumer, 3 800 mg/l. 1. When reference is made in the labelling to the flavouring pyroligneous distillate [FL no: 21.001] in the spirit drinks tuzemák and tuzemský, the name or the FL number shall be used. 2. Tuzemák and tuzemský to which pyroligneous distillate [FL no: 21.001] has been added shall not be used in the manufacture of other foodstuffs. 3. In addition to the requirements of Article 15 of Regulation (EC) No 1334/2008, when this flavouring is marketed as such, it shall be indicated in the labelling that this flavouring may only be used for the manufacture of the spirit drinks tuzemák and tuzemský. Member States shall require additional labelling, informing consumers about the specific risks linked to the presence of pyroligneous distillate [FL no. 21.001] in the spirit drinks tuzemák and tuzemský. | | EFSA

PART F

Source materials

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