Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Allura Red AC (E 129). Allura Red AC has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1980 and the EU Scientific Committee for Food (SCF) in 1984 and 1989. Both committees established an Acceptable Daily Intake (ADI) of 0-7 mg/kg body weight (bw)/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. New studies included a study by Tsuda et al. from 2001 reporting effects on nuclear DNA migration in the mouse in vivo Comet assay, and a study by McCann et al. from 2007 that concluded that exposure to a mixture including Allura Red AC, resulted in increased hyperactivity in 8-to 9-years old children. The Panel notes that Allura Red AC was negative in in vitro genotoxicity as well as in long-term carcinogenicity studies and that the effects on nuclear DNA migration observed in the mouse in vivo Comet assay are not expected to result in carcinogenicity. The Panel also concurrs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel concluded that the present database does not give reason to revise the ADI of 7 mg/kg bw/day. The Panel also concludes that at the maximum reported levels of use refined intake estimates are generally below the ADI, although in 1-10 years old children the high percentile of exposure (95th) can be slightly higher than the ADI at the upper end of the range.