Scientific Opinion on the re-evaluation of Brilliant Black BN (E 151) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Brilliant Black BN (E 151). Brilliant Black BN has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1981, and the EU Scientific Committee for Food (SCF) in 1984. JECFA established an Acceptable Daily Intake (ADI) of 1 mg/kg bw/day, whereas the SCF established an ADI of 5 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. In a recent study, Brilliant Black BN was found positive in a micronucleus test and a Comet assay in vitro. However, the Panel noted that Brilliant Black BN was negative in long-term carcinogenicity studies and that the effects on nuclear DNA migration observed in these assays are not expected to result in carcinogenicity. The Panel concluded that the present database does not give reason to revise the ADI of 5 mg/kg bw/day based on a long-term carcinogenicity and toxicity study in rats. The Panel concluded that at the current maximum reported levels of use of Brilliant Black BN, refined intake estimates are generally below the ADI of 5 mg/kg bw/day. However in children under 10 years, the 95th percentile can be 6.9 mg/kg bw/day and thus exceeds the ADI at the upper end of the range.