Scientific Opinion on the re-evaluation of Azorubine/Carmoisine (E 122) as a food additive



The Panel wishes to thank the members of the Working Group B on Food Additives and Nutrient Sources for the preparation of this opinion: D. Boskou, R. Charrondiere, B. Dusemund, D. Gott, T. Hallas-Møller, K.F.A.M. Hulshof, J. König, D. Parent-Massin, I.M.C.M. Rietjens, G.J.A. Speijers, P. Tobback, T. Verguieva, R.A. Woutersen.

Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2009; 7(11):1332 [40 pp.].
Panel members at the time of adoption
F. Aguilar, U.R. Charrondiere, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Guertler, J. Koenig, 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
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
24 September 2009
12 November 2009
Last Updated
24 November 2009. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Azorubine/Carmoisine (E 122). Azorubine/Carmoisine has previously been evaluated by JECFA in 1983 and the SCF in 1984. Both committees established an Acceptable Daily Intake (ADI) of 0-4 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. New studies included a study reporting alterations in the morphology of somatic chromosomes in Secale cereale (rye), and a study by McCann et al. that concluded that exposure to mixtures including Azorubine/Carmoisine, resulted in increased hyperactivity in 3-years old and 8- to 9-years old children. The Panel notes that the study in rye was not a standard genotoxicity assay, and concluded, given that all other genotoxicity tests were negative and that Azorubine/Carmoisine does not contain a structural alert, that there is no concern with respect to genotoxicity. The Panel also concurs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel concludes that the present database does not give reason to revise the ADI of 4 mg/kg bw/day. The Panel also concludes that at the maximum reported levels of use, refined intake estimates are below the ADI, although in 1- to 10-year old children the high percentile of exposure (95th) can be slightly higher than the ADI at the upper end of the range.

Azorubine, Carmoisine, E 122, CAS 3567-69-9, CI Acid Red 14, CI Food Red 3, food colouring substance, EINECS number 222-657-4
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