Revised exposure assessment for Sunset Yellow FCF based on the proposed revised maximum permitted levels of use as a food additive

Sunset yellow, E 110, revised MPLs, dietary exposure
First published in the EFSA Journal
5 settembre 2011
26 agosto 2011
Statement of EFSA


Following a request from the European Commission, the European Food Safety Authority (EFSA) carried out a revised exposure assessment for children of Sunset Yellow FCF (E 110) from its use as a food additive, based on the revised proposed use levels as provided by the European Commission. Four scenarios have been considered, differing only by the maximum permitted levels for use in flavoured drinks: 10, 15, 18 and 20 mg/l respectively. Revised exposure estimates have been calculated for Tier 2 applying the same methodology used by the Panel on Food Additives and Nutrient Sources added to Food (ANS) for the re-evaluation of food colours, based on the revised use levels combined with food consumption data for children. These exposure estimates could be considered as conservative as it is assumed that the food additive is used at the maximum permitted levels for all authorised uses. The mean anticipated dietary exposure to Sunset Yellow FCF in European children (aged 1-14 years) range from 0.02 to 0.4 mg/kg bw/day, and the high level estimates range from 0.08 to 1.2 mg/kg bw/day. The main contributors to the total anticipated exposure to Sunset Yellow FCF are non-alcoholic flavoured drinks and desserts including flavoured milk products. For all scenarios the high level exposure estimates for children calculated with the proposed revised Maximum Permitted Levels are below the temporary ADI of 1 mg/kg bw/day for all European countries considered (maximum of 0.8 mg/kg bw/day) except for UK pre-school children who might slightly exceed the ADI in scenarios 3 and 4 (1.1 and 1.2 mg/kg bw/day respectively).

European Food Safety Authority
ans [at]
EFSA Journal 2011;9(9):2349
Question Number
On request from
European Commission