Commission Regulation (EU) No 232/2012

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives^note, and in particular Article 10(3) thereof,Whereas:

(1)Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)Quinoline Yellow (E 104), Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) are food colours currently approved for use and listed in Annex II to Regulation (EC) No 1333/2008. The current approval takes into account the Acceptable Daily Intakes (ADI) established by the Scientific Committee for Food (SCF) in 1983^note.

(3)The European Food Safety Authority (hereinafter: ‘the Authority’) issued an Opinion on 23 September 2009^note related to the re-evaluation on the safety of Quinoline Yellow (E 104) as a food additive. In that Opinion, the Authority recommends to lower the ADI of that food colour from 10 mg/kg bw/day to 0,5 mg/kg bw/day. In addition, the Authority considers that the refined exposure estimates (Tier 2 and Tier 3) are generally well over the revised ADI of 0,5 mg/kg bw/day. It is therefore appropriate to amend the conditions of use and use levels for Quinoline Yellow (E 104) to ensure that the new ADI recommended by the Authority is not exceeded.

(4)The Authority issued an Opinion on 27 September 2009^note related to the re-evaluation on the safety of Sunset Yellow FCF/Orange Yellow S (E 110) as a food additive. In that Opinion, the Authority recommends to lower the ADI for Sunset Yellow FCF/Orange Yellow S (E 110) from 2,5 to 1 mg/kg bw/day. In addition, the Authority considers that the refined exposure estimates (Tier 3) are generally well over the revised temporary ADI of 1 mg/kg bw/day for high-consumer children. It is therefore appropriate to amend the conditions of use and use levels for Sunset Yellow FCF/Orange Yellow S (E 110) to ensure that the new temporary ADI recommended by the Authority is not exceeded.

(5)The Authority issued an Opinion on 23 September 2009^note related to the re-evaluation on the safety of Ponceau 4R, Cochineal Red A (E 124) as a food additive. In that Opinion, the Authority recommends to lower the ADI from 4 mg/kg bw/day to 0,7 mg/kg bw/day. In addition, the Authority considers that the refined exposure estimates (Tier 3) are generally well over the revised ADI of 0,7 mg/kg bw/day for high-consumer children. It is therefore appropriate to amend the conditions of use and use levels for Ponceau 4R, Cochineal Red A (E 124) to ensure that the new ADI recommended by the authority is not exceeded.

(6)It is necessary to remove these substances from Group III listed in Part C(3) of Annex II. However the combined maximum limit when the substances are used together with the remaining substances belonging to Group III should be maintained.

(7)In order to reduce the exposure below the recommended ADI, maximum limits should be revised. In particular they should be reduced by the same factor as the reduction in daily intake which is aimed at. Certain exceptions with higher levels should be allowed for some traditional products which do not significantly contribute to the exposure. Some provisions have also been deleted.

(8)Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.

(9)In order to allow the necessary time for the food industry to adjust their production to the new conditions of use and the use levels laid down in this Regulation, it is appropriate to provide for transitional arrangements.

(10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1 #

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2 #

This Regulation shall apply from 1 June 2013.Foods containing Quinoline Yellow (E 104), Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) that have been lawfully placed on the market before 1 June 2013 but that do not comply with the provisions of this Regulation, may continue to be marketed until stocks are exhausted.

Article 3 #

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

(1)in Part C, in point (3), the following entries are deleted:E 104 | Quinoline YellowE 110 | Sunset Yellow FCF/Orange yellow SE 124 | Ponceau 4R, Cochineal red A

(2)Part E is amended as follows:

(a)in the categories 03, 05.2, 05.3, 05.4, 07.2 and 14.1.4 footnote (25) is replaced by the following:‘(25):The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l’;

(b)in the category 1.7.5 footnote (33) is replaced by the following:‘(33):Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 160e and E 161b’;

(c)in the categories 04.2.1, 04.2.2, 04.2.3 and 04.2.4.1 footnote (34) is replaced by the following:‘(34):Maximum individually or for the combination of E 120, E 122, E 129, E 131 and E 133’;

(d)in the categories 04.2.5.2 and 04.2.5.3 footnote (31) is replaced by the following:‘(31):Maximum individually or in combination with E 120, E 142, E 160d and E 161b’;

(e)in the category 9.2 footnotes (35), (36) and (37) are replaced by the following:‘(35):Maximum individually or for the combination of E 102, E 120, E 122, E 142, E 151, E 160e and E 161b’‘(36):Maximum individually or for the combination of E 102, E 120, E 122, E 129, E 142, E 151, E 160e and E 161b’‘(37):Maximum individually or for the combination of E 102, E 120, E 151 and E 160e’;

(f)the following entries for E 104, E 110 and E 124 are inserted in numerical order in the food categories referred to:Category number | E-Number | Name | Maximum level(mg/l or mg/kg as appropriate) | Footnotes | restrictions/exceptions01.4 | Flavoured fermented milk products including heat treated productsE 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 5 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 5 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III01.6.3 | Other creamsE 104 | Quinoline Yellow | 10 | (61) | Only flavoured creamsE 110 | Sunset Yellow FCF/Orange Yellow S | 5 | (61) | Only flavoured creamsE 124 | Ponceau 4R, Cochineal Red A | 5 | (61) | Only flavoured creams(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III01.7.3 | Edible cheese rindE 104 | Quinoline Yellow | 10 | (62) |(62):The total quantity of E 104 and the colours in Group III shall not exceed the maximum listed for Group III04.2.4.1 | Fruit and vegetable preparations excluding compoteE 104 | Quinoline Yellow | 30 | (61) | Only mostarda di fruttaE 110 | Sunset Yellow FCF/Orange Yellow S | 35 | (61) | Only mostarda di fruttaE 124 | Ponceau 4R, Cochineal Red A | 20 | (61) | Only mostarda di frutta(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III05.2 | Other confectionery including breath refreshening microsweetsE 104 | Quinoline Yellow | 30 | (61) | except candied fruit and vegetables; traditional sugar coated nut- or cocoa-based confectionery of almond shape or host shape, typically longer than 2 cm and typically consumed at celebratory occasions, i.e. weddings, communion, etc.E 110 | Sunset Yellow FCF/Orange Yellow S | 35 | (61) | except candied fruit and vegetables; traditional sugar coated nut- or cocoa-based confectionery of almond shape or host shape, typically longer than 2 cm and typically consumed at celebratory occasions, i.e. weddings, communion, etc.E 124 | Ponceau 4R, Cochineal Red A | 20 | (61) | except candied fruit and vegetables; traditional sugar coated nut- or cocoa-based confectionery of almond shape or host shape, typically longer than 2 cm and typically consumed at celebratory occasions, i.e. weddings, communion, etc.E 104 | Quinoline Yellow | 30 | (61) | only candied fruit and vegetablesE 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) | only candied fruit and vegetablesE 124 | Ponceau 4R, Cochineal Red A | 10 | (61) | only candied fruit and vegetablesE 104 | Quinoline Yellow | 300 | (61) | only traditional sugar coated nut- or cocoa-based confectionery of almond shape or host shape, typically longer than 2 cm and typically consumed at celebratory occasions, i.e. weddings, communion, etc.E 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (61) | only traditional sugar coated nut- or cocoa-based confectionery of almond shape or host shape, typically longer than 2 cm and typically consumed at celebratory occasions, i.e. weddings, communion, etc.E 124 | Ponceau 4R, Cochineal Red A | 50 | (61) | only traditional sugar coated nut- or cocoa-based confectionery of almond shape or host shape, typically longer than 2 cm and typically consumed at celebratory occasions, i.e. weddings, communion, etc.(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III05.3 | Chewing gumE 104 | Quinoline Yellow | 30 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III05.4 | Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4E 104 | Quinoline Yellow | 50 | (61) | only decorations, coatings and sauces, except fillingsE 110 | Sunset Yellow FCF/Orange Yellow S | 35 | (61) | only decorations, coatings and sauces, except fillingsE 124 | Ponceau 4R, Cochineal Red A | 55 | (61) | only decorations, coatings and sauces, except fillingsE 104 | Quinoline Yellow | 50 | (61) | only fillingsE 110 | Sunset Yellow FCF/Orange Yellow S | 35 | (61) | only fillingsE 124 | Ponceau 4R, Cochineal Red A | 55 | (61) | only fillings(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III06.6 | BattersE 104 | Quinoline Yellow | 50 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 35 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 55 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III08.2.3 | Casings and coatings and decorations for meatE 104 | Quinoline Yellow | 50 | (61) | only decorations and coatings except edible external coating of pasturmasE 110 | Sunset Yellow FCF/Orange Yellow S | 35 | (61) | only decorations and coatings except edible external coating of pasturmasE 124 | Ponceau 4R, Cochineal Red A | 55 | (61) | only decorations and coatings except edible external coating of pasturmasE 104 | Quinoline Yellow | 10 | (62) | only edible casings(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III(62):The total quantity of E 104 and the colours in Group III shall not exceed the maximum listed for Group III09.2 | Processed fish and fishery products including molluscs and crustaceansE 110 | Sunset Yellow FCF/Orange Yellow S | 200 | (63) | only in salmon substitutes based on Theragra chalcogramma and Pollachius virensE 124 | Ponceau 4R, Cochineal Red A | 200 | (63) | only in salmon substitutes based on Theragra chalcogramma and Pollachius virens(63):The total quantity of E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III09.3 | Fish roeE 104 | Quinoline Yellow | 200 | (61) | except Sturgeons’ eggs (Caviar)E 110 | Sunset Yellow FCF/Orange Yellow S | 200 | (61) | except Sturgeons’ eggs (Caviar)E 124 | Ponceau 4R, Cochineal Red A | 200 | (61) | except Sturgeons’ eggs (Caviar)(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III12.2.2 | Seasonings and condimentsE 104 | Quinoline Yellow | 10 | (62) | only seasonings, for example curry powder, tandoori(62):The total quantity of E 104 and the colours in Group III shall not exceed the maximum listed for Group III12.4 | MustardE 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 35 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III12.6 | SaucesE 104 | Quinoline Yellow | 20 | (64) | including pickles, relishes, chutney and piccalilli; excluding tomato-based saucesE 110 | Sunset Yellow FCF/Orange Yellow S | 30 | (64) | only in pickles and piccalilli(64):The total quantity of E 104 and E 110 and the colours in Group III shall not exceed the maximum listed for Group III12.9 | Protein products, excluding products covered in category 1.8E 104 | Quinoline Yellow | 10 | (61) | only meat and fish analogues based on vegetable proteinsE 110 | Sunset Yellow FCF/Orange Yellow S | 20 | (61) | only meat and fish analogues based on vegetable proteinsE 124 | Ponceau 4R, Cochineal Red A | 10 | (61) | only meat and fish analogues based on vegetable proteins(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III13.2 | Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)E 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III13.3 | Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet)E 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III14.1.4 | Flavoured drinksE 104 | Quinoline Yellow | 10 | (61) | excluding chocolate milk and malt productsE 110 | Sunset Yellow FCF/Orange Yellow S | 20 | (61) | excluding chocolate milk and malt productsE 124 | Ponceau 4R, Cochineal Red A | 10 | (61) | excluding chocolate milk and malt products(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III14.2.3 | Cider and perryE 104 | Quinoline Yellow | 25 | (64) | excluding cidre bouchéE 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (64) | excluding cidre bouché(64):The total quantity of E 104, E 110 and the colours in Group III shall not exceed the maximum listed for Group III14.2.4 | Fruit wine and made wineE 104 | Quinoline Yellow | 20 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 1 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III14.2.7.1 | Aromatised winesE 104 | Quinoline Yellow | 50 | (61) | Except americano, bitter vinoE 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (61) | Except americano, bitter vinoE 124 | Ponceau 4R, Cochineal Red A | 50 | (61) | Except americano, bitter vino(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III14.2.7.2 | Aromatised wine-based drinksE 104 | Quinoline Yellow | 50 | (61) | except bitter soda, sangria, claria, zurraE 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (61) | except bitter soda, sangria, claria, zurraE 124 | Ponceau 4R, Cochineal Red A | 50 | (61) | except bitter soda, sangria, claria, zurra(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III14.2.7.3 | Aromatised wine-product cocktailsE 104 | Quinoline Yellow | 50 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 50 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III14.2.8 | Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcoholE 104 | Quinoline Yellow | 180 | (61) | only alcoholic drinks with less than 15 % of alcoholE 110 | Sunset Yellow FCF/Orange Yellow S | 100 | (61) | only alcoholic drinks with less than 15 % of alcoholE 124 | Ponceau 4R, Cochineal Red A | 170 | (61) | only alcoholic drinks with less than 15 % of alcohol(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III16. | Desserts excluding products covered in categories 1, 3 and 4E 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 5 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III17.1 | Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable formsE 104 | Quinoline Yellow | 35 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 35 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III17.2 | Food supplements supplied in a liquid formE 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III17.3 | Food supplements supplied in a syrup-type or chewable formE 104 | Quinoline Yellow | 10 | (61) |E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) |E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) |(61):The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III

(g)category 08.2.1 is amended as follows:

(h)category 14.2.7.1 is amended as follows:

(i)the entries for E 104 and E 110 are replaced by the following:| E 104 | Quinoline Yellow | 50 | (26) (27) | only americano, bitter vino| E 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (27) | only bitter vino

(ii)the entry for E 124 is replaced by the following:| E 124 | Ponceau 4R, Cochineal Red A | 50 | (26) (27) | only americano, bitter vino

(i)category 14.2.7.2 is amended as follows:

(i)the entries for E 104 and E 110 are replaced by the following:| E 104 | Quinoline Yellow | 50 | (28) | only bitter soda| E 110 | Sunset Yellow FCF/Orange Yellow S | 50 | (28) | only bitter soda

(ii)the entry for E 124 is replaced by the following:| E 124 | Ponceau 4R, Cochineal Red A | 50 | (28) | only bitter soda

(j)the following entries for E 104, E 110 and E 124 are deleted in the food categories referred to:01.7.5 | Processed cheeseE 104 | Quinoline Yellow | 100 | (33) | only flavoured processed cheeseE 110 | Sunset Yellow FCF/Orange Yellow S | 100 | (33) | only flavoured processed cheeseE 124 | Ponceau 4R, Cochineal Red A | 100 | (33) | only flavoured processed cheese04.2.1 | Dried fruit and vegetablesE 124 | Ponceau 4R, Cochineal Red A | 200 | (34) | only preserves of red fruit04.2.2 | Fruit and vegetables in vinegar, oil, or brineE 124 | Ponceau 4R, Cochineal Red A | 200 | (34) | only preserves of red fruit04.2.3 | Canned or bottled fruit and vegetablesE 124 | Ponceau 4R, Cochineal Red A | 200 | (34) | only preserves of red fruit04.2.4.1 | Fruit and vegetable preparations excluding compoteE 124 | Ponceau 4R, Cochineal Red A | 200 | (34) | only preserves of red fruit04.2.5.2 | Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/ECE 104 | Quinoline Yellow | 100 | (31) | except chestnut pureeE 110 | Sunset Yellow FCF/Orange Yellow S | 100 | (31) | except chestnut pureeE 124 | Ponceau 4R, Cochineal Red A | 100 | (31) | except chestnut puree04.2.5.3 | Other similar fruit or vegetable spreadsE 104 | Quinoline Yellow | 100 | (31) | except crème de pruneauxE 110 | Sunset Yellow FCF/Orange Yellow S | 100 | (31) | except crème de pruneauxE 124 | Ponceau 4R, Cochineal Red A | 100 | (31) | except crème de pruneaux08.2.1 | Non heat treated processed meatE 124 | Ponceau 4R, Cochineal Red A | 200 | | only sobrasada09.2 | Processed fish and fishery products including molluscs and crustaceansE 104 | Quinoline Yellow | 100 | (35) | only fish paste and crustacean pasteE 110 | Sunset Yellow FCF/Orange Yellow S | 100 | (35) | only fish paste and crustacean pasteE 124 | Ponceau 4R, Cochineal Red A | 100 | (35) | only fish paste and crustacean pasteE 110 | Sunset Yellow FCF/Orange Yellow S | 250 | (36) | only precooked crustaceanE 124 | Ponceau 4R, Cochineal Red A | 250 | (36) | only precooked crustaceanE 110 | Sunset Yellow FCF/Orange Yellow S | 100 | (37) | only smoked fishE 124 | Ponceau 4R, Cochineal Red A | 100 | (37) | only smoked fish

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

Commission Regulation (EU) No 232/2012

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