EN    EN   
 EUROPEAN COMMISSION   
Brussels, XXX  
SANCO/.../2011  
[…](2011) XXX draft   
  
COMMISSION REGULATION (EU) No …/..  
of XXX  
amendin g Annex II to Re gulation (EC) No 1333/2008 of the European Parliament and 
of the Council with re gard to conditions of use and use le vels of Quinoline Yellow, Sunset 
Yellow and Ponceau 4R  
(Text with EEA relevance)   
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council with regard to conditions of use and use levels of Quinoline Yellow, Sunset 
Yellow and Ponceau 4R  
(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 1331/2008 of the European Parliament and of the 
Council of 16 December 2008 establishing a co mmon authorisation procedure for food 
additives, food enzymes and food flavourings , in particular Article 7(5) thereof
1, 
After consulting the European Food Safety Authority Whereas: (1) Regulation (EC) No 1333/2008 of the European  Parliament and of the Council of 16 
December 2008 on food additives
2 lays down a Union list of food additives approved 
for use in foods and their conditions of use. 
(2) Commission Regulation XXXX amends Annex II to Regulation (EC) No 1333/2008 
of the European Parliament and of the C ouncil by establishing a Union list of food 
additives3. 
(3) Quinoline Yellow (E 104) is a food colour currently authorised under Annex II to 
Regulation (EC) No 1333/2008. The European F ood Safety Authority (hereinafter: 'the 
Authority') re-evaluated the safety of Qu inoline Yellow (E 104)  and recommended to 
lower down its acceptable da ily intake (ADI) from 10 mg/kg bw/d to 0.5 mg/kg 
bw/day in its opinion on 23 September 20094. In addition, the Authority considered 
that the refined exposure estimates (Tier 2 and Tier 3) are ge nerally well over the 
revised ADI of 0.5 mg/kg bw/day. It is th erefore appropriate to reduce the current 
                                                 
1 OJ L 354, 31.12.2008, p. 1. 
2  OJ L 354, 31.12.2008, p. 16. 
3  [OJ reference to be added]  
4 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.   
EN 3   EN conditions of use and use levels for Quino line Yellow to ensure that the new ADI is 
not exceeded any more. 
(4) Sunset Yellow (E 110) is a food colour currently authorised  under Annex II to 
Regulation (EC) No 1333.2008. The Authority re -evaluated the sa fety of Sunset 
Yellow5. Based on the available scientific data, the Authority considered necessary to 
reduce the ADI by an extra uncer tainty factor of 2.5, leading to 1 mg/kg bw/day and to 
make the ADI temporary for 2 years, un tl September 2011. In addition, the Authority 
considered that the refined exposure esti mates (Tier 3) are ge nerally well over the 
revised temporary ADI of 1 mg/kg bw/day for high cons umer children. It is therefore 
appropriate to reduce the current conditions of use and use levels for Sunset Yellow to ensure that the new temporary ADI is not exceeded anymore. 
(5) Ponceau 4R (E 124) is a food colour currently authorised under Annex II to 
Regulation (EC) No 1333/2008. The Authority re-evaluated the safety of Ponceau 4R 
and recommended to lower down the ADI from 4 mg/kg bw/d to 0.7 mg/kg bw/d in its 
opinion
6 on 23 September 2009. In addition, the Aut hority considered that the refined 
exposure estimates (Tier 3) are generall y well over the revised ADI of 0.7 mg/kg 
bw/day for high consumer children. It is th erefore appropriate to reduce the current 
conditions of use and use levels for Ponceau 4R to ensure that the new ADI is not 
exceeded any more. 
(6) In order to allow the necessary time for th e food industry to deve lop alternatives to 
these current authroisations, it is neceerasy to provide for transitional arrangements.   
(7)  The measures provided for in this Regul ation are in accordance with the opinion of 
the […] Committee, 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 by [date of entry into force + 24 months] 
                                                 
5 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 safe ty of Sunset Yellow (E 110) as a food additive, The 
EFSA Journal 2009; 7(11):1330. 
6 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.  
EN 4   EN Foods containing Quinoline Yellow, Sunset Yellow  and Ponceau 4R that have been lawfully 
placed on the market before [date of entry into  force + 24 months], but do not comply with 
this Regulation, may continue to be marketed until stocks are exhausted.  
Article 3 
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 the Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN ANNEX  
ANNEX  
Annex II to Regulation (EC) No 1333/2008 is amended as follows: 
(1) In Part C (3) Group III: Food co lours with combined maximum limit 
 
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) In Part E the following entries for E 104, E 110, E 124  are inserted :  
 
PART E: AUTHORISED FOOD ADDITIVES AND CONDITIONS OF USE IN FOOD CATEGORIES  
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 (59)   
EN 6   EN  E 110 Sunset Yellow FCF/Orange 
Yellow S 5 (59)  
 E 124 Ponceau 4R, Cochineal Red A 5 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
01.6.3 Other creams  
 E 104 Quinoline Yellow 10 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 5 (59)  
 E 124 Ponceau 4R, Cochineal Red A 5 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
01.7.3 Edible cheese rind  
 E 104 Quinoline Yellow 10 (60)  
  (60): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
04.2.4.1 Fruit and vegetable p reparations excluding compote  
 E 104 Quinoline Yellow 30 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 35 (59)  
 E 124 Ponceau 4R, Cochineal Red A 20 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
05.2 Other confectionery including  breath refreshening microsweets  
 E 104 Quinoline Yellow 30 (59) 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 cons umed at celebratory occasions ie: 
weddings, communion etc. 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 35 (25) (59) 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 cons umed at celebratory occasions ie: 
weddings, communion etc. 
 
 E 124 Ponceau 4R, Cochin eal Red A 20 (25) (59) except candied fruit and vegetables; traditional sugar coated nut- or  
EN 7   EN cocoa-based confectionery of almond shape or host shape, typically 
longer than 2 cm and typically cons umed at celebratory occasions ie: 
weddings, communion etc.  
 E 104 Quinoline Yellow 30 (59) only candied fruit and vegetables  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59) only candied fruit and vegetables  
 E 124 Ponceau 4R, Cochineal Red A 10 (59) only candied fruit and vegetables  
 E 104 Quinoline Yellow 50  (59) 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 ie: weddings, communion etc. 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (25) (59) 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 ie: weddings, communion etc. 
 E 124 Ponceau 4R, Cochin eal Red A 300 (25) (59) 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 ie: weddings , communion etc. 
  (25): The quantities of each of the colours E 110, E 122, E 124 and E 155 may not exceed 50 mg/kg or mg/l 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
05.3 Chewing gum  
 E 104 Quinoline Yellow 30  (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (25) (59)  
 E 124 Ponceau 4R, Cochin eal Red A 10 (25) (59)  
  (25): The quantities of each of the colours E 110, E 122, E 124 and E 155 may not exceed 50 mg/kg or mg/l 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
05.4 Decorations, coatings and fillings, except fruit based fillings covered  by category 4.2.4  
 E 104 Quinoline Yellow 50 (59) only decorations, coatings and sauces, except fillings  
EN 8   EN  E 110 Sunset Yellow FCF/Orange 
Yellow S 35 (59) only decorations, coatings and sauces, except fillings  
 E 124 Ponceau 4R, Cochineal Red A 55 (59) only decorations, coatings and sauces, except fillings  
 E 104 Quinoline Yellow 50  (59) only fillings 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 35 (25) (59) only fillings  
 E 124 Ponceau 4R, Cochin eal Red A 55 (25) (59) only fillings  
  (25): The quantities of each of the colours E 110, E 122, E 124 and E 155 may not exceed 50 mg/kg or mg/l 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
06.6 Batters  
 E 104 Quinoline Yellow 50 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 35 (59)  
 E 124 Ponceau 4R, Cochineal Red A 55 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
08.2.3 Casings and coatings  and decorations for meat  
 E 104 Quinoline Yellow 50 (59) only decorations and coatings except edible external coating of 
pasturmas  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 35 (59) only decorations and coatings except edible external coating of 
pasturmas  
 E 124 Ponceau 4R, Cochineal Red A 55 (59) only decorations and coatings except edible external coating of 
pasturmas  
 E 104 Quinoline Yellow 10 (59) only edible casings 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
09.2 Processed fish and fishery pro ducts including mollusks and crustaceans  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 200 (35) (59) only in salmon substitutes based on Theragra chalcogramma  and 
Pollachius virens  
 E 124 Ponceau 4R, Cochineal Red A 55 (59) only in salmon substitutes based on Theragra chalcogramma  and  
EN 9   EN Pollachius virens  
  (35): Maximum indiviually or for the combination of E 102, E 104, E 110, E 120, E 122, E 124, E 142, E 151, E 160e, E 161b 
  (37): Maximum indiviually or for the combination of E 102, E 110, E 120, E 124, E 151, E 160e 
09.3 Fish roe  
 E 104 Quinoline Yellow 200 (59) except Sturgeons' eggs (Caviar) 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 200 (59) except Sturgeons' eggs (Caviar) 
 E 124 Ponceau 4R, Cochineal Red A 55 (59) except Sturgeons' eggs (Caviar) 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
12.2.2 Seasonings and condiments  
 E 104 Quinoline Yellow 10 (59) only seasonings, for example curry powder, tandoori 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
12.4 Mustard  
 E 104 Quinoline Yellow 10 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (59)  
 E 124 Ponceau 4R, Cochineal Red A 35 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
12.6 Sauces  
 E 104 Quinoline Yellow 20 (59) including pickles, relishes, chutney and picalilli; excluding tomato-
based sauces 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 30 (59) only in pickles and picalilli 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
12.9 Protein products, excluding products covered in category 1.8  
 E 104 Quinoline Yellow 10 (59) only meat and fish analogues based on vegetable proteins 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 20 (59) only meat and fish analogues based on vegetable proteins 
 E 124 Ponceau 4R, Cochineal Red A 10 (59) only meat  and fish analogues base d on vegetable proteins  
EN 10   EN   (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
13.2 Dietary foods for special medical purpo ses defined in Directive 1999/21/EC (excludi ng products from food category 13.1.5) 
 E 104 Quinoline Yellow 10 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59)  
 E 124 Ponceau 4R, Cochineal Red A 10 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
13.3 Dietary foods for weight co ntrol diets intended to replace total daily food in take or an individual meal (the whole or par t of the total daily diet) 
 E 104 Quinoline Yellow 10 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59)  
 E 124 Ponceau 4R, Cochineal Red A 10 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
14.1.4 Flavoured drinks  
 E 104 Quinoline Yellow 10 (59) excluding chocolate milk and malt products 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 20 (25) (59) excluding chocolate milk and malt products 
 E 124 Ponceau 4R, Cochineal Re d A 10 (25) (59) excluding choc olate milk and malt products 
  (25): The quantities of each of the colours E 110, E 122, E 124 and E 155 may not exceed 50 mg/kg or mg/l 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
14.2.3 Cider and perry  
 E 104 Quinoline Yellow 25 (59) excluding cidre bouché 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59) excluding cidre bouché 
  (59): 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 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59)   
EN 11   EN  E 124 Ponceau 4R, Cochineal Red A 1 (59)  
  (59): The total quantity of  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 (59) Except americano, bitter vino  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (59) Except americano, bitter vino  
 E 124 Ponceau 4R, Cochineal Red A 50 (59) Except americano, bitter vino  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
14.2.7.2 Aromatised wine-based drinks  
 E 104 Quinoline Yellow 50 (59) except bitter soda, sangria, claria, zurra  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (59) except bitter soda, sangria, claria, zurra  
 E 124 Ponceau 4R, Cochineal Red A 50 (59) except bitter soda, sangria, claria, zurra  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
14.2.7.3 Aromatised wine-product cocktails  
 E 104 Quinoline Yellow 50 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (59)  
 E 124 Ponceau 4R, Cochineal Red A 50 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
14.2.8 Other alcoholic drinks including mixt ures of alcoholic drinks with non-alcoholic  drinks and spirits with less than 15 % of alcohol 
 E 104 Quinoline Yellow 180 (59) only alcoholic drinks with less than 15 % of alcohol 
 E 110 Sunset Yellow FCF/Orange 
Yellow S 100 (59) only alcoholic drinks with less than 15 % of alcohol 
 E 124 Ponceau 4R, Cochineal Red A 170 (59) only al coholic drinks with less than 15 % of alcohol 
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
16. Desserts excluding products co vered in category 1, 3 and 4  
 E 104 Quinoline Yellow 10 (59)   
EN 12   EN  E 110 Sunset Yellow FCF/Orange 
Yellow S 5 (59)  
 E 124 Ponceau 4R, Cochineal Red A 10 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
17.1 Food supplements supplied in a solid form including caps ules and tablets and similar fo rms, excluding chewable forms 
 E 104 Quinoline Yellow 35 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59)  
 E 124 Ponceau 4R, Cochineal Red A 35 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
17.2 Food supplements supplied in a liquid form  
 E 104 Quinoline Yellow 10 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59)  
 E 124 Ponceau 4R, Cochineal Red A 10 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
17.3 Food supplements supplied in a syrup-type or chewable form  
 E 104 Quinoline Yellow 10 (59)  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 10 (59)  
 E 124 Ponceau 4R, Cochineal Red A 10 (59)  
  (59): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group II I 
(3) In Part E the current entries for E 104, E 110, E 124  are replaced by the following: 
   
08.2.1 Non heat treated processed meat  
 E 110 Sunset yellow FCF/Orange 
Yellow S 15  only sobrasada   
EN 13   EN  E 124 Ponceau 4R, Cochineal Red A 50  only chorizo sausage/salchichon  
14.2.7.1 Aromatised wines  
 E 104 Quinoline Yellow 50 (26) (27) only americano, bitter vino  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (27) only bitter vino  
 E 124 Ponceau 4R, Cochineal  Red A 50 (26) (27) only americano, bitter vino  
14.2.7.2 Aromatised wine-based drinks  
 E 104 Quinoline Yellow 50 (28) only bitter soda  
 E 110 Sunset Yellow FCF/Orange 
Yellow S 50 (28) only bitter soda  
 E 124 Ponceau 4R, Cochineal Red A 50 (28) only bitter soda  
(4) In Part E the following entries for E 104, E 110, E 124  are deleted:   
 
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 
04.2.5.2 Jam, jellies and marmalade s and sweetened chestn ut 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  
EN 14   EN  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 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 
08.2.1 Non heat treated processed meat  
 E 124 Ponceau 4R, Cochineal Red A 200  only sobrasada  
09.2 Processed fish and fishery pro ducts including mollusks 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 past e and crustacean paste 
 E 124 Ponceau 4R, Cochineal Red A 100 (3 5) 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 Re d A 100 (37) only smoked fish