Refined exposure assessment of Brown HT (E 155)

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(5):3719 [26 pp.].
doi
10.2903/j.efsa.2014.3719
Acknowledgements

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.

Contact
Type
Statement of EFSA
On request from
EFSA
Question Number
EFSA-Q-2012-00884
Approved
28 May 2014
Published
28 May 2014
Last Updated
23 July 2014. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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.

Summary

EFSA carried out a refined exposure assessment for Brown HT (E 155) taking into account additional information on its use in foods and beverages as consumed.

Brown HT (E 155) is a synthetic bis-azo dye authorised as a food additive in the European Union (EU) for use in foods according to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, as amended. It was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1977 (JECFA, 1978) and the EU Scientific Committee for Food (SCF) in 1984 (SCF, 1984). In 1984, JECFA established an ADI of 0-1.5 mg/kg bw/day (JECFA, 1984), while the SCF established an ADI of 0-3 mg/kg bw/day (SCF, 1984).

In 2010, the EFSA ANS Panel adopted a scientific opinion on the re-evaluation of Brown HT (E 155) as a food additive. The ANS Panel concluded that at both the maximum permitted levels (MPLs) and maximum reported levels of use of Brown HT (E 155), mean intake estimates were generally below the ADI of 1.5 mg/kg bw/day. However, in both adults and 1-10 year old children, the high percentiles of exposure (95th/97.5th percentiles) can exceed the ADI at the upper end of the range (EFSA, 2010a).

Recently, new data on the actual uses of Brown HT (E 155) in foods and beverages as consumed were submitted to EFSA by industry following a call for data. In addition, analytical results reported by competent authorities through a call for data were also obtained. The present statement provides the exposure assessment of Brown HT (E 155) based on current MPLs, recently reported information on use levels (ULs) and individual consumption data from the EFSA Comprehensive European Food Consumption Database. Three exposure scenarios were considered: (i) based on MPLs (MPL scenario), (ii) based on the combination of MPLs and reported maximum use levels, if available (ULa scenario), and (iii) based on reported maximum use levels only (ULb scenario).

Scenarios used for the exposure assessment for the total population based on MPLs (MPL scenario) or use levels in reported food categories combined with MPLs for other categories (ULa scenario) led to exceedance of the ADI of 1.5 mg/kg/bw/day. The mean exposure estimates for Brown HT (E 155) are above the ADI for toddlers and children (about to two times higher from the ADI for toddlers), while high level estimates (95th percentile) are above the ADI for all populations groups, with the exception for the elderly. The results of the current exposure assessment of Brown HT (E 155) are for the mean exposure estimates in line with the evaluation carried out in 2010, while the 95th percentile exposure is estimated to be lower, particularly in adults. This is due to different usage level data submitted, more food consumption data being available and a detailed nomenclature of foods categories thus allowing a detailed selection of foods which can contain Brown HT (E 155).

The exposure assessment scenario based on reported use data only (ULb scenario) showed considerably lower exposure for all population groups with both mean and high level estimates below the ADI of 1.5 mg/kg bw/day. The mean dietary exposures to Brown HT (E 155) for toddlers and children were up to 0.05 mg/kg bw/day and 0.04 mg/kg bw/day, respectively, while exposure estimates at the 95th percentile exposure were up to 0.25 mg/kg bw/day and 0.21 mg/kg bw/day, respectively. For adolescents, mean and high level dietary exposure to Brown HT (E 155) were up to 0.03 mg/kg bw/day and 0.16 mg/kg bw/day, respectively. Mean dietary exposure to Brown HT (E 155) for adults was up to 0.03 mg/kg bw/day; high level (95th percentile) exposure estimates were up to 0.09 mg/kg bw/day. For the elderly, the dietary exposure to Brown HT (E 155) was very low (up to 0.01 mg/kg bw/day for the mean exposure; up to 0.04 mg/kg bw/day for the 95th percentile exposure). Due to the limited number of use levels reported, the outcome of this scenario is considered to underestimate exposure to Brown HT (E 155).

Keywords
Brown HT, E 155, dietary exposure, EFSA Comprehensive European Food Consumption Database, food colours
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Number of Pages
26