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

Abstract

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 (95 th ) can be slightly higher than the ADI at the upper end of the range. KEY WORDSAzorubine, Carmoisine, E 122, CAS 3567-69-9, CI Acid Red 14, CI Food Red 3, food colouring substance, EINECS number 222-657-4. The Panel noted that the specifications on the purity of Azorubine/Carmoisine permit concentrations of unidentified unsulphonated aromatic amines to be present in concentrations of up to 100 mg/kg Azorubine/Carmoisine. Although some aromatic amines may be associated with genotoxicity or even carcinogenicity, the Panel notes that Azorubine/Carmoisine was negative in in vitro genotoxicity studies and an in vivo genotoxicity study as well as in long-term carcinogenicity studies.The Panel concurs with the view expressed in previous evaluations by JECFA and TemaNord that the absorption of Azorubine/Carmoisine is limited, but that after reduction in the gastrointestinal tract, free sulphonated aromatic amines may reach the systemic circulation.The SCF and also the JECFA and TemaNord evaluations concluded, based on in vivo and in vitro studies available at that time, that Azorubine/Carmoisine does not show any genotoxic activity.In a more recent study, Zaharia and Pavel have tested four colourings, Tartrazine (E 102), Azorubine/Carmoisine (E 122), Patent Blue (E 131) and Acid Green 50 (E 142), on the frequency of divisional cells, mitotic index, mutagenic process, and the potential of these synthetic colourings to induce chromosomal modifications. Using cyt...

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Food Colour Additives: A Synoptical Overview on Their Chemical Properties, Applications in Food Products, and Health Side Effects

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