Azorubine / Carmoisine

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Children — EFSA found high-consuming children aged 1–10 could exceed the ADI at maximum permitted levels, and carmoisine in dye mixtures was linked to increased hyperactivity in children aged 3 and 8–9 years (McCann et al., 2007); EU regulations require a mandatory 'may have an adverse effect on activity and attention in children' label.

Other — Individuals with known hypersensitivity, atopic conditions, or prior sensitisation to azo dyes are at risk of allergic skin reactions including fixed drug eruptions, as documented in peer-reviewed clinical case reports (PMC6759534).

Epilepsy — As an azo dye with documented neurological effects (hyperactivity links) in sensitive populations, individuals with neurological conditions including epilepsy should consult a physician before regular consumption of E122-containing products.

Research citations

The sources behind this verdict.

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

Independently researched6 citations