Refined exposure assessment for Brilliant Black BN (E 151)

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Article
European Food Safety Authority
Acknowledgements

EFSA wishes to thank: Jean-Charles Leblanc for the preparatory work on this scientific output, and EFSA staff : Alexandra Tard, Davide Arcella, Petra Gergelova and Stavroula Tasiopoulou for the support provided to this scientific output.

EFSA Journal
EFSA Journal 2015;13(1):3960 [33 pp.].
doi
10.2903/j.efsa.2015.3960
Contact
Type
Statement of EFSA
On request from
EFSA
Question Number
EFSA-Q-2012-00887
Approved
11 December 2014
Published
9 January 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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).

Keywords
Brilliant Black BN, E 151, dietary exposure, EFSA Comprehensive European Food Consumption Database, food colours
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Number of Pages
33