About
Azorubine (Carmoisine) is a synthetic azo dye that imparts a vivid red to deep crimson colour to food and beverages. It is used in soft drinks, bakery products, jams, confectionery, and desserts primarily for aesthetic appeal.
Safety summary
JECFA (1983) and EFSA (2009) both established an ADI of 4 mg/kg bw/day, unchanged for over four decades. High-consuming children aged 1–10 can potentially exceed this ADI at maximum permitted intake levels, though EFSA's refined 2015 exposure assessment found the ADI was not exceeded under realistic consumption scenarios. A mixture including carmoisine was linked to increased hyperactivity in 3- and 8–9-year-old children (McCann et al., 2007), though EFSA concluded this finding was insufficient to revise the ADI; no genotoxicity concern was identified. Hypersensitivity and allergic skin reactions have been reported in sensitised individuals.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| MHLW (Ministry of Health, Labour and Welfare) (Japan) | Banned | Japan does not permit Carmoisine (E122) for use in food or drinks; referenced in peer-reviewed literature (PubMed PMID:37806207). |
| FDA (Food and Drug Administration) (United States) | Banned | Carmoisine (CI 14720, E122) is not an approved color additive for food use in the US; it was formerly certifiable as Ext. D&C Red No. 10 but is no longer permitted. Products found to contain it are flagged as non-compliant in FDA import alerts (Import Alert 45-02).source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved under Regulation (EC) No 1333/2008 in up to 50 food categories including soft drinks, bakery products, and desserts. Products containing E122 must carry the mandatory warning label 'may have an adverse effect on activity and attention in children' per EU Regulation (EC) No 1333/2008 / Commission Regulation (EU) No 1129/2011.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Listed as INS 122 (Azorubine/Carmoisine) under permitted food colour additives in FSSAI Food Safety and Standards (Food Products Standards and Food Additives) Regulations. Subject to purity standards including limits on lead, arsenic, and heavy metals; preparations must be free from sediment (liquid) or visible extraneous matter (powder).source |
Who should approach with care
Research citations
- 1FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations – Appendix C: Permitted Food Additives. fssai.gov.in
- 2PubMed. A pediatric case report of fixed drug eruption related to carmoisine colorant present in paracetamol syrup. pmc.ncbi.nlm.nih.gov
- 3PubMed. Recent advances in electrochemical sensors based on nanomaterials for detection of red dyes in food products: A review, 2024. pubmed.ncbi.nlm.nih.gov
- 4FDA. FDA Compliance Program Guidance Manual – Color Additives in Foods, 2019. fda.gov
- 5EFSA. Refined Exposure Assessment for Azorubine/Carmoisine (E 122), 2015. efsa.europa.eu
- 6EFSA. Scientific Opinion on the Re-evaluation of Azorubine/Carmoisine (E 122) as a food additive, 2009. efsa.europa.eu
