Refined exposure assessment for Quinoline Yellow (E 104)


European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(3):4070 [33 pp.].

EFSA wishes to thank Polly Boon, Jean-Charles Leblanc and Oliver Lindtner, for the preparatory work on this scientific output and EFSA staff: Davide Arcella, Petra Gergelova, Alexandra Tard and Stavroula Tasiopoulou, for the support provided to this scientific output. EFSA acknowledges those European competent authorities, food industry and other stakeholders that provided occurrence data (usage and analytical data) on Quinoline Yellow (E 104) in food and beverages, and supported the data collection for the Comprehensive European Food Consumption Database.

Statement of EFSA
On request from
European Commission
Question Number
23 March 2015
Published in the EFSA Journal
25 March 2015
European Food Safety Authority (EFSA), Parma, Italy

The European Food Safety Authority (EFSA) carried out an exposure assessment of Quinoline Yellow (E 104), taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Quinoline Yellow (E 104) and concluded that, at the maximum usage levels, refined intake estimates were generally well above the Acceptable Daily Intake (ADI) of 0.5 mg/kg body weight (bw)/day. Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission as regards the conditions of use such that Maximum Permitted Levels (MPLs), when not withdrawn (n = 14), were decreased by a factor of 1.1 to 50, depending on the food category, applicable from 1 June 2013 onwards. Following this, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Quinoline Yellow (E 104) in foods were requested from relevant stakeholders through a call for usage and analytical data. Usage levels were provided to EFSA for 6 out of 28 food categories in which Quinoline Yellow (E 104) is authorised. In addition, 6 266 analytical results were reported. Following the amendment of Annex II to Regulation (EC) No 1333/2008, exposure estimates for Quinoline Yellow (E 104) presented in this statement were based on the currently authorised MPLs and analytical levels combined with food consumption data from the EFSA Comprehensive Food Consumption Database. Three scenarios were considered: (1) exposure estimates based on MPLs, (2) a refined brand-loyal exposure scenario and (3) a refined non-brand-loyal exposure scenario. Mean and high-level exposure estimates of Quinoline Yellow (E 104) were below the ADI for all population groups in all three scenarios.

Quinoline Yellow, E 104, dietary exposure, EFSA Comprehensive European Food Consumption Database, food colours
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