(1)

Annex II to Regulation (EC) No 1333/2008 is amended as follows: (a) in point 2 of Part A, point 5 is replaced by the following: ‘5. The colours E 123, E 127, E 160b(i), E 160b(ii), E 161g, E 173 and E 180 and mixtures thereof may not be sold directly to the consumer.’ (b) in Part B, point 1: ‘Colours’, the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following two entries: ‘E 160b(i) Annatto bixin E 160b(ii) Annatto norbixin’ (c) Part E is amended as follows: 1) Category 01.4 (Flavoured fermented milk products including heat-treated products) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 15 (94) E 160b(ii) Annatto norbixin 4 (94)’ (ii) the following footnote (94) is added after footnote (74): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 2) Category 01.7.2 (Ripened cheese) is amended as follows: (i) the entries for E 160b (Annatto, Bixin, Norbixin) are replaced by the following: ‘E 160b(i) Annatto bixin 15 (94) only ripened orange, yellow and broken-white cheese and red and green pesto cheese E 160b(ii) Annatto norbixin 15 (94) only ripened orange, yellow and broken-white cheese and red and green pesto cheese E 160b(ii) Annatto norbixin 50 only red Leicester cheese E 160b(ii) Annatto norbixin 35 only Mimolette cheese’ (ii) the following footnote (94) is added after footnote (83): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 3) Category 01.7.3 (Edible cheese rind) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 20 (94) E 160b(ii) Annatto norbixin 20 (94)’ (ii) the following footnote (94) is added after footnote (67): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 4) Category 01.7.5 (Processed cheese) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 15 (94) E 160b(ii) Annatto norbixin 8 (94)’ (ii) the following footnote (94) is added after footnote (66): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 5) in Category 01.7.6 (Cheese products (excluding products falling in category 16)), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(ii) Annatto norbixin 8 only ripened orange, yellow and broken-white products’ 6) in category 02.1 (Fats and oils essentially free from water (excluding anhydrous milkfat)), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 10 only fats’ 7) in category 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 10 excluding reduced fat butter’ 8) in category 03 (Edible ices), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(ii) Annatto norbixin 20’ 9) Category 04.2.5.2 (Jam, jellies and marmalades and sweetened chestnut purée as defined by Directive 2001/113/EC) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 160a (Carotenes): ‘E 160b(i) Annatto bixin 20 (94) except chestnut purée E 160b(ii) Annatto norbixin 20 (94) except chestnut purée’ (ii) the following footnote (94) is added after footnote (66): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 10) Category 04.2.5.3 (Other similar fruit or vegetable spreads) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 142 (Green S): ‘E 160b(i) Annatto bixin 20 (94) except crème de pruneaux E 160b(ii) Annatto norbixin 20 (94) except crème de pruneaux’ (ii) the following footnote (94) is added after footnote (60): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 11) Category 04.2.6 (Processed potato products) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 160a (Carotenes): ‘E 160b(i) Annatto bixin 10 (94) only dried potato granules and flakes E 160b(ii) Annatto norbixin 10 (94) only dried potato granules and flakes’ (ii) the following footnote (94) is added after footnote (46): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 12) Category 05.2 (Other confectionery including breath freshening microsweets) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entries for E 124 (Ponceau 4R, Cochineal Red A): ‘E 160b(i) Annatto bixin 30 (94) E 160b(ii) Annatto norbixin 25 (94)’ (ii) the following footnote (94) is added after footnote (72): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 13) Category 05.4 (Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 80 (94) only decorations and coatings E 160b(ii) Annatto norbixin 20 (94) only decorations and coatings’ (ii) the following footnote (94) is added after footnote (73): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 14) in category 06.3 (Breakfast cereals), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(ii) Annatto norbixin 20 only extruded puffed and or fruit-flavoured breakfast cereals’ 15) Category 06.5 (Noodles) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for group II (Colours at quantum satis): ‘E 160b(i) Annatto bixin 20 (94) E 160b(ii) Annatto norbixin 20 (94)’ (ii) the following footnote (94) is added after footnote (81): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 16) Category 06.6 (Batters) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 50 (94) only batters for coating E 160b(ii) Annatto norbixin 50 (94) only batters for coating’ (ii) the following footnote (94) is added after footnote (81): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 17) in category 07.2 (Fine bakery wares), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(ii) Annatto norbixin 10’ 18) Category 08.2 (Meat preparations as defined by Regulation (EC) No 853/2004) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 150a-d (Caramels): ‘E 160b(i) Annatto bixin 20 (94) only breakfast sausages with a minimum cereal content of 6 % and burger meat with a minimum vegetable and/or cereal content of 4 % mixed within the meat; In these products, the meat is minced in such a way so that the muscle and fat tissue are completely dispersed, so that fibre makes an emulsion with the fat, giving those products their typical appearance E 160b(ii) Annatto norbixin 20 (94) only breakfast sausages with a minimum cereal content of 6 % and burger meat with a minimum vegetable and/or cereal content of 4 % mixed within the meat; In these products, the meat is minced in such a way so that the muscle and fat tissue are completely dispersed, so that fibre makes an emulsion with the fat, giving those products their typical appearance’ (ii) the following footnote (94) is added after footnote (66): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 19) Category 08.3.1 (Non-heat–treated meat products) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 160a (Carotenes): ‘E 160b(i) Annatto bixin 20 (94) only chorizo sausage, salchichon, pasturmas and sobrasada E 160b(ii) Annatto norbixin 20 (94) only chorizo sausage, salchichon, pasturmas and sobrasada’ (ii) the following footnote (94) is added after footnote (66): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 20) Category 08.3.2 (Heat-treated meat products) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 160a (Carotenes): ‘E 160b(i) Annatto bixin 20 (94) only sausages, pâtés, terrines and luncheon meat E 160b(ii) Annatto norbixin 20 (94) only sausages, pâtés, terrines and luncheon meat’ (ii) the following footnote (94) is added after footnote (66): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 21) Category 08.3.3 (Casings and coatings and decorations for meat) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 50 (94) E 160b(ii) Annatto norbixin 50 (94)’ (ii) the following footnote (94) is added after footnote (89): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 22) Category 09.2 (Processed fish and fishery products including molluscs and crustaceans) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) concerning ‘only smoked fish’ is replaced by the following new entries for Annatto bixin and Annato norbixin, respectively for ‘only smoked fish’ and for ‘only surimi and similar products and salmon substitutes’: ‘E 160b(i) Annatto bixin 10 (94) only smoked fish E 160b(i) Annatto bixin 30 (94) only surimi and similar products and salmon substitutes E 160b(ii) Annatto norbixin 10 (94) only smoked fish E 160b(ii) Annatto norbixin 30 (94) only surimi and similar products and salmon substitutes’ (ii) the following footnote (94) is added after footnote (85): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 23) Category 12.5 (Soups and broths) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for Group III (Colours with combined maximum limit): ‘E 160b(i) Annatto bixin 15 (94) E 160b(ii) Annatto norbixin 10 (94)’ (ii) the following footnote (94) is added after footnote (60): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 24) Category 12.6 (Sauces) is amended as follows: (i) the following new entries for E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are inserted after the entry for E 110 (Sunset Yellow FCF/Orange Yellow S): ‘E 160b(i) Annatto bixin 30 (94) including pickles, relishes, chutney and piccalilli; excluding tomato-based sauces E 160b(ii) Annatto norbixin 30 (94) including pickles, relishes, chutney and piccalilli; excluding tomato-based sauces’ (ii) the following footnote (94) is added after footnote (65): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 25) in category 14.1.4 (Flavoured drinks), the following new entry for E 160b(i) (Annatto bixin) is inserted after the entry for E 124 (Ponceau 4R, Cochineal Red A): ‘E 160b(i) Annatto bixin 20’ 26) in category 14.2.6 (Spirit drinks as defined in Regulation (EC) No 110/2008), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 10 only liqueurs’ 27) in category 14.2.8 (Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(ii) Annatto norbixin 10 only alcoholic drinks with less than 15 % of alcohol’ 28) Category 15.1 (Potato-, cereal-, flour- or starch-based snacks) is amended as follows: (i) the two entries for E 160b (Annatto, Bixin, Norbixin) are replaced by the following: ‘E 160b(i) Annatto bixin 20 (94) E 160b(ii) Annatto norbixin 20 (94)’ (ii) the following footnote (94) is added after footnote (71): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 29) Category 15.2 (Processed nuts) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 10 (94) E 160b(ii) Annatto norbixin 10 (94)’ (ii) the following footnote (94) is added after footnote (60): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’ 30) Category 16 (Desserts excluding products covered in category 1, 3 and 4) is amended as follows: (i) the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following: ‘E 160b(i) Annatto bixin 15 (94) E 160b(ii) Annatto norbixin 7,5 (94)’ (ii) the following footnote (94) is added after footnote (74): ‘(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the higher individual maximum level applies to the sum, but the individual maximum levels shall not be exceeded.’