Scientific Opinion on the re-evaluation of Brilliant Black BN (E 151) as a food additive

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

The Panel wishes to thank the members of the Working Group A on Food Additives and Nutrient Sources of the ANS Panel for the preparation of this opinion: F. Aguilar, N Bemrah, P. Galtier, J. Gilbert, S. Grilli, R. Gürtler, N-G. Ilback, C. Lambré, J.C. Larsen, J-C. Leblanc, A. Mortensen, I. Pratt, I. Stankovic, C. Tlustos.

EFSA Journal
EFSA Journal 2010;8(4):1540 [30 pp.].
doi
10.2903/j.efsa.2010.1540
Panel members at the time of adoption
F. Aguilar, U.R. Charrondiere, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Gürtler, J. Köenig, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D. Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2008-241
Adopted
11 March 2010
Published
21 April 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Brilliant Black BN (E 151). Brilliant Black BN has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1981, and the EU Scientific Committee for Food (SCF) in 1984. JECFA established an Acceptable Daily Intake (ADI) of 1 mg/kg bw/day, whereas the SCF established an ADI of 5 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. In a recent study, Brilliant Black BN was found positive in a micronucleus test and a Comet assay in vitro. However, the Panel noted that Brilliant Black BN was negative in long-term carcinogenicity studies and that the effects on nuclear DNA migration observed in these assays are not expected to result in carcinogenicity. The Panel concluded that the present database does not give reason to revise the ADI of 5 mg/kg bw/day based on a long-term carcinogenicity and toxicity study in rats. The Panel concluded that at the current maximum reported levels of use of Brilliant Black BN, refined intake estimates are generally below the ADI of 5 mg/kg bw/day. However in children under 10 years, the 95th percentile can be 6.9 mg/kg bw/day and thus exceeds the ADI at the upper end of the range.

Keywords
Brilliant Black BN, Brilliant Black PN, Black PN, E151, CAS Registry Number 2519-30-4, tetrasodium 4-acetamido-5-hydroxy-6-[7-sulphonato-4-(4-sulphonatophenylazo)-1-naphtylazo]naphthalene-1,7-disulphonate, food colouring substance, EINECS number 219-746-5
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Number of Pages
30