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Refined exposure assessment for Brilliant Black BN (E 151)

on the Wiley Online Library



The European Food Safety Authority (EFSA) carried out an exposure assessment of Brilliant Black BN (E 151), taking into account new information on its use as a food additive in foods. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Brilliant Black BN and concluded that dietary exposure in 1- to 10-year-old children at the high level may exceed the Acceptable Daily Intake (ADI) for Brilliant Black BN of 5 mg/kg body weight (bw)/day at the upper end of the range. Following this conclusion, the European Commission requested that EFSA performs a refined exposure assessment for this food colour. Data on the presence of Brilliant Black BN in foods were requested from relevant stakeholders through a call for usage and concentration data. Usage levels were provided to EFSA for 11 out of 37 food categories in which Brilliant Black is authorised. In addition, 4 337 analytical results were also reported to EFSA, with the majority of values being below the limit of detection (LOD) or limit of quantification (LOQ). Exposure assessment was performed using the EFSA Comprehensive Food Consumption Database. Three scenarios were considered: (1) exposure estimates based on Maximum Permitted Levels (MPLs), (2) a refined brand-loyal exposure scenario, and (3) a refined non-brand-loyal exposure scenario. Considering the first scenario, high exposure levels (95th percentile) exceeded the ADI for toddlers and children in four dietary surveys. In comparison with the previous assessment, for both children and adults, the current mean exposure estimates are of the same order of magnitude, whereas the 95th percentile exposure is lower, particularly in adults. The mean and high-level exposure estimates of Brilliant Black BN are below the ADI for all population groups when considering the refined scenarios (brand-loyal and non-brand-loyal).