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Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive

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The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Brilliant Blue FCF (E 133). Brilliant Blue FCF has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970 and the EU Scientific Committee for Food (SCF) in 1975. Both committees established an ADI of 12.5 mg/kg bw/day. In 1984, the SCF revised the ADI to 10 mg/kg bw/day, based on new long-term studies. The Panel concluded that the present dataset on the absorption, distribution, metabolism and excretion, genotoxicity, subchronic, reproductive, developmental and long-term toxicity, and carcinogenicity give reason to revise the ADI of 10 mg/kg bw/day allocated by the SCF in 1984. The Panel considered that the NOAEL of 631 mg/kg bw/day from the chronic toxicity study in rat can be used to allocate a new ADI to Brilliant Blue FCF. By application of an uncertainty factor of 100, the Panel established a new ADI to Brilliant Blue FCF equal to 6 mg/kg bw/day. The Panel concluded that at the maximum reported levels of use of Brilliant Blue FCF, refined intake estimates (Tier 3) are lower than the ADI of 6 mg/kg bw/day. The Panel concluded that at Tier 2 the intake estimates are below the ADI at the mean for both adults and children and at the higher level for adults, but above the ADI at the higher level (95th percentile) for children.