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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)
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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(1), 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(2).
(3) The European Food Safety Authority (hereinafter: ‘the Authority’) issued an Opinion on 23 September 2009(3) 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(4) 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(5) 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:
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
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.
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 II to Regulation (EC) No 1333/2008 is amended as follows:
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’’ |
Part E is amended as follows:
in the categories 03, 05.2, 05.3, 05.4, 07.2 and 14.1.4 footnote (25) is replaced by the following:
in the category 1.7.5 footnote (33) is replaced by the following:
in the categories 04.2.1, 04.2.2, 04.2.3 and 04.2.4.1 footnote (34) is replaced by the following:
in the categories 04.2.5.2 and 04.2.5.3 footnote (31) is replaced by the following:
in the category 9.2 footnotes (35), (36) and (37) are replaced by the following:
the following entries for E 104, E 110 and E 124 are inserted in numerical order in the food categories referred to:
category 08.2.1 is amended as follows:
the entry for E 110 is replaced by the following:
‘E 110 | Sunset yellow FCF/Orange Yellow S | 15 | only sobrasada’ |
the entry for E 124 is replaced by the following:
‘E 124 | Ponceau 4R, Cochineal Red A | 50 | only chorizo sausage/salchichon’ |
category 14.2.7.1 is amended as follows:
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’ |
the entry for E 124 is replaced by the following:
‘E 124 | Ponceau 4R, Cochineal Red A | 50 | (26) (27) | only americano, bitter vino’ |
category 14.2.7.2 is amended as follows:
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’ |
the entry for E 124 is replaced by the following:
‘E 124 | Ponceau 4R, Cochineal Red A | 50 | (28) | only bitter soda’ |
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’ |
Reports of the Scientific Committee for Food, Fourteenth series, 1983.
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.
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.
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.
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