Open AccessScientific Opinion on the re‐evaluation of Azorubine/Carmoisine (E 122) as a food additive
Author(s) -
Francis Aguilar,
U. Ruth Charrondière,
Birgit Dusemund,
Pierre Galtier,
Juan Manuel de Faramiñán Gilbert,
David Michael Gott,
Sandro Grilli,
R. Guertler,
J. Koenig,
Claude Lambré,
John Chr. Larsen,
JeanCharles Leblanc,
A. Mortensen,
D. Parent Massin,
Iona Pratt,
I.M.C.M. Rietjens,
Ivan Stanković,
Paul Tobback,
T. Verguieva,
Rudolf Antonius Woutersen
Publication year - 2009
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2009.1332
Subject(s) - food science , novel food , biology , chemistry
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.