Refined exposure assessment of Brown HT (E 155)


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(5):3719 [26 pp.].

EFSA wishes to thank the EFSA staff members: Davide Arcella, Petra Gergelova, Alexandra Tard, Stavroula Tasiopoulou for the preparatory work on this scientific output, and the members of the Working Group on Exposure Assessment: Polly Boon, Jürgen König, Jean-Charles Leblanc, Olivier Lindtner, Christophe Matthys and Christina Tlustos for the support provided to this scientific output.

Statement of EFSA
On request from
Question Number
28 May 2014
Published in the EFSA Journal
28 May 2014
Last Updated
23 July 2014. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

The European Food Safety Authority (EFSA) carried out an exposure assessment of Brown HT (E 155) taking into account additional information on its use in foods as consumed. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Brown HT and concluded that dietary exposure in both adults and 1-10 year old children at the high level may exceed the Acceptable Daily Intake (ADI) for Brown HT of 1.5 mg/kg body weight (bw)/day at the upper end of the range. Following this conclusion, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Brown HT in foods were requested from relevant stakeholders through a call for usage and concentration data. Usage levels were provided to EFSA for six out of 37 food categories in which Brown HT is authorised. A limited number of analytical results were also reported to EFSA, all below the limit of detection (LOD) or limit of quantification (LOQ). Exposure assessment was performed using the EFSA Comprehensive Food Consumption Database. Three different scenarios were considered, including i) exposure estimates based on Maximum Permitted Levels (MPLs), ii) a combination of MPLs and reported maximum use levels and iii) reported maximum use levels only. Considering the first two scenarios, high exposure levels (95th percentile) exceeded the ADI for all age groups, with exception for the elderly. In comparison to the previous assessment, for both children and adults, the current mean exposure estimates are of the same order of magnitude, while the 95th percentile exposure is lower, particularly in adults. The mean and high level exposure estimates of Brown HT are below the ADI for all population groups when considering the reported use levels only.

Brown HT, E 155, dietary exposure, EFSA Comprehensive European Food Consumption Database, food colours
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