Azorubine

Uses

In the US, this color was listed in 1939 as 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.

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, and is permitted for use as an excipient in medications.

There are no provisions for azorubine in the Codex Alimentarius.

Safety

Azorubine has shown no evidence of mutagenic or carcinogenic properties and an acceptable daily intake (ADI) of 0–4 mg/kg was established in 1983 by the WHO. In rare instances, it may cause skin and respiratory allergic reactions even to FDA approved dosages.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6759534/#ref4

No evidence supports broad claims that food coloring causes food intolerance and ADHD-like behavior in children. It is possible that certain food coloring may act as a trigger in those who are genetically predisposed, but the evidence is weak.

References

References

1. (2005). "Azo Dyes".
2. [https://pubchem.ncbi.nlm.nih.gov/compound/19118?from=summary Pubchem entry]
3. [https://hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives&id=ExtDCRed10 Regulatory Status of Color Additives: Ext. D&C Red No. 10]
4. FDA. [https://web.archive.org/web/20110331210358/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/UCM248549.pdf 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, 2011]
5. FDA. 9 November 2008. [https://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm072848.pdf Food and Drug Administration, Compliance Program Guidance Manual, Chapter 03 - Foodborne Biological Hazards]{{dead link. (May 2025)
6. link. (11 December 2014 Accessed 6 December 2014)
7. EU. 19 June 2007 [http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003382.pdf Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product]
8. [http://ec.europa.eu/food/fs/sfp/addit_flavor/flav08_en.pdf Directive 94/36/EC - European Commission]
9. [https://web.archive.org/web/20060610005124/http://www.codexalimentarius.net/gsfaonline/additives/details.html?id=91 Azorubine (Carmoisine) (122) in the GSFA Online Database] Accessed 6 December 2014
10. WHO, 1983. [http://whqlibdoc.who.int/trs/WHO_TRS_696.pdf Evaluation of certain food additives and contaminants]. Linked from [http://apps.who.int/food-additives-contaminants-jecfa-database/chemical.aspx?chemINS=122 WHO listing here]
11. Tomaska LD and Brooke-Taylor, S. ''Food Additives - General'' pp 449-454 in Encyclopedia of Food Safety, Vol 2: Hazards and Diseases. Eds, Motarjemi Y et al. Academic Press, 2013. {{ISBN. 9780123786135
12. (February 2012). "The diet factor in attention-deficit/hyperactivity disorder". Pediatrics.