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(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:
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.