文章基本信息

标题：Scientific Opinion on the re-evaluation of Azorubine/Carmoisine (E 122) as a food additive
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作者：F. Aguilar ; U.R. Charrondiere ; B. Dusemund 等
期刊名称：EFSA Journal
印刷版ISSN：1831-4732
出版年度：2009
卷号：7
期号：11
DOI：10.2903/j.efsa.2009.1332
出版社：European Food Safety Authority (EFSA), Parma
摘要：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.
关键词：Azorubine; Carmoisine; E 122; CAS 3567-69-9; CI Acid Red 14; CI Food Red 3; food colouring substance; EINECS number 222-657-4