Commission Regulation (EU) No 232/2012
of 16 March 2012
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the conditions of use and the use levels for Quinoline Yellow (E 104), Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124)
(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, and in particular Article 10(3) thereof,
OJ L 354, 31.12.2008, p. 16.
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.
Reports of the Scientific Committee for Food, Fourteenth series, 1983.
(3) The European Food Safety Authority (hereinafter: ‘the Authority’) issued an Opinion on 23 September 2009 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.
Scientific opinion of the Panel on Food Additives and Nutrient sources added to Food (ANS) on a request from the Commission related to the re-evaluation on the safety of Quinoline Yellow (E 104) when used as a food additive, The EFSA Journal 2009; 7(11):1329.
(4) The Authority issued an Opinion on 27 September 2009 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.
Scientific opinion of the Panel on Food Additives and Nutrient sources added to Food (ANS) on a request from the Commission related to the re-evaluation on the safety of Sunset Yellow (E 110) as a food additive, The EFSA Journal 2009; 7(11):1330.
(5) The Authority issued an Opinion on 23 September 2009 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.
Scientific opinion of the Panel on Food Additives and Nutrient sources added to Food (ANS) on a request from the Commission related to the re-evaluation on the safety of Ponceau 4R as a food additive, The EFSA Journal 2009; 7(11):1328.
(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.
This Regulation shall be binding in its entirety and directly applicable in the Member States.
Done at Brussels, 16 March 2012.
For the Commission
The President
José Manuel Barroso
ANNEX Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) in Part C, in point (3), the following entries are deleted:

‘E 104	Quinoline Yellow
‘E 110	Sunset Yellow FCF/Orange yellow S’
‘E 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/exceptions
‘01.4	Flavoured fermented milk products including heat treated products				
	E 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 III			
01.6.3	Other creams				
	E 104	Quinoline Yellow	10	(61)	Only flavoured creams
	E 110	Sunset Yellow FCF/Orange Yellow S	5	(61)	Only flavoured creams
	E 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 III			
01.7.3	Edible cheese rind				
	E 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 III			
04.2.4.1	Fruit and vegetable preparations excluding compote				
	E 104	Quinoline Yellow	30	(61)	Only mostarda di frutta
	E 110	Sunset Yellow FCF/Orange Yellow S	35	(61)	Only mostarda di frutta
	E 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 III			
05.2	Other confectionery including breath refreshening microsweets				
	E 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 vegetables
	E 110	Sunset Yellow FCF/Orange Yellow S	10	(61)	only candied fruit and vegetables
	E 124	Ponceau 4R, Cochineal Red A	10	(61)	only candied fruit and vegetables
	E 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 III			
05.3	Chewing gum				
	E 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 III			
05.4	Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4				
	E 104	Quinoline Yellow	50	(61)	only decorations, coatings and sauces, except fillings
	E 110	Sunset Yellow FCF/Orange Yellow S	35	(61)	only decorations, coatings and sauces, except fillings
	E 124	Ponceau 4R, Cochineal Red A	55	(61)	only decorations, coatings and sauces, except fillings
	E 104	Quinoline Yellow	50	(61)	only fillings
	E 110	Sunset Yellow FCF/Orange Yellow S	35	(61)	only fillings
	E 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 III			
06.6	Batters				
	E 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 III			
08.2.3	Casings and coatings and decorations for meat				
	E 104	Quinoline Yellow	50	(61)	only decorations and coatings except edible external coating of pasturmas
	E 110	Sunset Yellow FCF/Orange Yellow S	35	(61)	only decorations and coatings except edible external coating of pasturmas
	E 124	Ponceau 4R, Cochineal Red A	55	(61)	only decorations and coatings except edible external coating of pasturmas
	E 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 III			
09.2	Processed fish and fishery products including molluscs and crustaceans				
	E 110	Sunset Yellow FCF/Orange Yellow S	200	(63)	only in salmon substitutes based on Theragra chalcogramma and Pollachius virens
	E 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 III			
09.3	Fish roe				
	E 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 III			
12.2.2	Seasonings and condiments				
	E 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 III			
12.4	Mustard				
	E 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 III			
12.6	Sauces				
	E 104	Quinoline Yellow	20	(64)	including pickles, relishes, chutney and piccalilli; excluding tomato-based sauces
	E 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 III			
12.9	Protein products, excluding products covered in category 1.8				
	E 104	Quinoline Yellow	10	(61)	only meat and fish analogues based on vegetable proteins
	E 110	Sunset Yellow FCF/Orange Yellow S	20	(61)	only meat and fish analogues based on vegetable proteins
	E 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 III			
13.2	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 III			
13.3	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 III			
14.1.4	Flavoured drinks				
	E 104	Quinoline Yellow	10	(61)	excluding chocolate milk and malt products
	E 110	Sunset Yellow FCF/Orange Yellow S	20	(61)	excluding chocolate milk and malt products
	E 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 III			
14.2.3	Cider and perry				
	E 104	Quinoline Yellow	25	(64)	excluding cidre bouché
	E 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 III			
14.2.4	Fruit wine and made wine				
	E 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 III			
14.2.7.1	Aromatised wines				
	E 104	Quinoline Yellow	50	(61)	Except americano, bitter vino
	E 110	Sunset Yellow FCF/Orange Yellow S	50	(61)	Except americano, bitter vino
	E 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 III			
14.2.7.2	Aromatised wine-based drinks				
	E 104	Quinoline Yellow	50	(61)	except bitter soda, sangria, claria, zurra
	E 110	Sunset Yellow FCF/Orange Yellow S	50	(61)	except bitter soda, sangria, claria, zurra
	E 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 III			
14.2.7.3	Aromatised wine-product cocktails				
	E 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 III			
14.2.8	Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol				
	E 104	Quinoline Yellow	180	(61)	only alcoholic drinks with less than 15 % of alcohol
	E 110	Sunset Yellow FCF/Orange Yellow S	100	(61)	only alcoholic drinks with less than 15 % of alcohol
	E 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 III			
16.	Desserts excluding products covered in categories 1, 3 and 4				
	E 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 III			
17.1	Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms				
	E 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 III			
17.2	Food supplements supplied in a liquid form				
	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 III			
17.3	Food supplements supplied in a syrup-type or chewable form				
	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 III’			

(g) category 08.2.1 is amended as follows:
(i) the entry for E 110 is replaced by the following:

	‘E 110	Sunset yellow FCF/Orange Yellow S	15		only sobrasada’

(ii) the entry for E 124 is replaced by the following:

	‘E 124	Ponceau 4R, Cochineal Red A	50		only chorizo sausage/salchichon’

(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 cheese				
	E 104	Quinoline Yellow	100	(33)	only flavoured processed cheese
	E 110	Sunset Yellow FCF/Orange Yellow S	100	(33)	only flavoured processed cheese
	E 124	Ponceau 4R, Cochineal Red A	100	(33)	only flavoured processed cheese
04.2.1	Dried fruit and vegetables				
	E 124	Ponceau 4R, Cochineal Red A	200	(34)	only preserves of red fruit
04.2.2	Fruit and vegetables in vinegar, oil, or brine				
	E 124	Ponceau 4R, Cochineal Red A	200	(34)	only preserves of red fruit
04.2.3	Canned or bottled fruit and vegetables				
	E 124	Ponceau 4R, Cochineal Red A	200	(34)	only preserves of red fruit
04.2.4.1	Fruit and vegetable preparations excluding compote				
	E 124	Ponceau 4R, Cochineal Red A	200	(34)	only preserves of red fruit
04.2.5.2	Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC				
	E 104	Quinoline Yellow	100	(31)	except chestnut puree
	E 110	Sunset Yellow FCF/Orange Yellow S	100	(31)	except chestnut puree
	E 124	Ponceau 4R, Cochineal Red A	100	(31)	except chestnut puree
04.2.5.3	Other similar fruit or vegetable spreads				
	E 104	Quinoline Yellow	100	(31)	except crème de pruneaux
	E 110	Sunset Yellow FCF/Orange Yellow S	100	(31)	except crème de pruneaux
	E 124	Ponceau 4R, Cochineal Red A	100	(31)	except crème de pruneaux
08.2.1	Non heat treated processed meat				
	E 124	Ponceau 4R, Cochineal Red A	200		only sobrasada
09.2	Processed fish and fishery products including molluscs and crustaceans				
	E 104	Quinoline Yellow	100	(35)	only fish paste and crustacean paste
	E 110	Sunset Yellow FCF/Orange Yellow S	100	(35)	only fish paste and crustacean paste
	E 124	Ponceau 4R, Cochineal Red A	100	(35)	only fish paste and crustacean paste
	E 110	Sunset Yellow FCF/Orange Yellow S	250	(36)	only precooked crustacean
	E 124	Ponceau 4R, Cochineal Red A	250	(36)	only precooked crustacean
	E 110	Sunset Yellow FCF/Orange Yellow S	100	(37)	only smoked fish
	E 124	Ponceau 4R, Cochineal Red A	100	(37)	only smoked fish’