Scientific Opinion on the re-evaluation of Azorubine/Carmoisine (E 122) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Azorubine/Carmoisine (E 122). Azorubine/Carmoisine has previously been evaluated by JECFA in 1983 and the SCF in 1984. Both committees established an Acceptable Daily Intake (ADI) of 0-4 mg/kg 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 reporting alterations in the morphology of somatic chromosomes in Secale cereale (rye), and a study by McCann et al. that concluded that exposure to mixtures including Azorubine/Carmoisine, resulted in increased hyperactivity in 3-years old and 8- to 9-years old children. The Panel notes that the study in rye was not a standard genotoxicity assay, and concluded, given that all other genotoxicity tests were negative and that Azorubine/Carmoisine does not contain a structural alert, that there is no concern with respect to genotoxicity. The Panel also concurs 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 concludes that the present database does not give reason to revise the ADI of 4 mg/kg bw/day. The Panel also concludes that at the maximum reported levels of use, refined intake estimates are below the ADI, although in 1- to 10-year old children the high percentile of exposure (95th) can be slightly higher than the ADI at the upper end of the range