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Refined exposure assessment for Ponceau 4R (E 124)

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Abstract

Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for Ponceau 4R (E 124) 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 Ponceau 4R (E 124) used as a food additive. In that opinion, the Panel concluded that, at the maximum levels of use, intake estimates for adults at the high percentile (97.5th) and for 1- to 10-year old children at the mean and high percentiles (95th/97.5th) were generally above the Acceptable Daily Intake (ADI), even for the refined intake estimates. Consequently, Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission regarding the conditions of use of Ponceau 4R (E 124), applicable as from 1 June 2013. Many Maximum Permitted Levels (MPLs) of Ponceau 4R (E 124) were withdrawn (n = 24) or decreased by a factor 1.2 to 200 (n = 29), depending on the food category. Following this, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as analytical data submitted to EFSA by Member States, combined with food consumption data of the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided for three out of the 31 food categories for which Ponceau 4R (E 124) is authorised as a food additive; while analytical data from Member States were provided to EFSA for 18 food categories. Using MPLs and these new data, none of the exposure estimates exceeded the ADI of 0.7 mg/kg bw per day in any population.