Azorubine, also known as carmoisine, is an azo dye consisting of two naphthalene subunits. It is a red solid. It is mainly used in foods that are heat-treated after fermentation. It has E number E122.Pubchem entry
Uses In the US, this color was listed in 1939 as Ext. D&C Red No. 10Regulatory Status of Color Additives: Ext. D&C Red No. 10 for use in externally applied drugs and cosmetics. It was delisted in 1963 because no party was interested in supporting the studies needed to establish safety. It was not used in food in the US.FDA. Background Document for the Food Advisory Committee: Certified Color Additives in Food and Possible Association with Attention Deficit Hyperactivity Disorder in Children: March 30-31, 2011FDA. 9 November 2008. Food and Drug Administration, Compliance Program Guidance Manual, Chapter 03 - Foodborne Biological Hazards p37
In the EU, azorubine is known as E number E122, and is authorized for use in certain foods and beverages, such as cheeses, dried fruit, and some alcoholic beverages,Azorubine entry in EU Food Additive Database Accessed 6 December 2014 and is permitted for use as an excipient in medications.EU. 19 June 2007 Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal ProductDirective 94/36/EC - European Commission
There are no provisions for azorubine in the Codex Alimentarius.Azorubine (Carmoisine) (122) in the GSFA Online Database Accessed 6 December 2014
Safety The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) for azorubine of 0–4 mg/kg of body weight per day in 1983. In 2009, the European Food Safety Authority (EFSA) re-evaluated azorubine and retained the 4 mg/kg ADI, concluding that the available data showed no concern regarding genotoxicity and that evidence was insufficient to establish that azorubine directly induces sensitivity reactions.
Azorubine is one of the "Southampton Six", a group of six synthetic food colors that also includes tartrazine (E102), quinoline yellow (E104), sunset yellow (E110), Ponceau 4R (E124), and Allura red (E129). In a 2007 study by researchers at the University of Southampton, the colors were tested across two distinct mixtures containing sodium benzoate; azorubine was one of two colors included in both trial mixtures. EFSA reviewed the trial in 2008 and concluded that it provided limited evidence of a small effect of the tested mixtures on activity and attention in some children, but that the trial design could not identify which individual additives were responsible.
Under Article 24 and Annex V of Regulation (EC) No 1333/2008, foods sold in the European Union containing azorubine must carry the color's name or E number accompanied by the warning statement that it "may have an adverse effect on activity and attention in children".
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