E122 · Azorubine, Carmoisine
- WHO
- Safe in moderation
- FDA
- Better avoided
- EFSA
- Safe in moderation
- FSANZ
- Safe in moderation
- Japan
- Better avoided
- UK FSA
- Safe in moderation
- Health Canada
- Better avoided
What is E122?
Azorubine (Carmoisine) is a synthetic azo dye used to give a red colour to foods, beverages, and some medicines. It is authorised in the EU/UK and Australia/New Zealand with maximum use levels and requires the EU hyperactivity warning label, but it is not permitted in foods in the United States, Canada, or Japan.
Also appears on labels as: E122, E 122, E-122, Azorubine, Carmoisine, Food Red 3, CI 14720, Acid Red 14, Carmoisine A, Azorubine Carmoisine, Red azo dye E122, Colouring E122.
What the evidence says
- EU/UK warning: may have an adverse effect on activity and attention in children.
- Hypersensitivity reactions possible in susceptible individuals (e.g., some with asthma/aspirin intolerance).
Research behind the verdict
- Carmoisine (E122) Allergic Reactions and Exposure Assessment — A. Mahajan et al., Indian Journal of Pharmacology (2019). A case report described a 5-year-old boy who developed a fixed drug eruption when given a paracetamol syrup containing the colourant carmoisine (E122); a patch test confirmed sensitivity, showing that carmoisine can cause rare allergic skin reactions even at permitted doses【633330200995111†L159-L193】【633330200995111†L190-L268】. An EFSA refined exposure assessment found that using actual use levels, exposure did not exceed the ADI (4 mg/kg bw/day) for any population group, although maximum permitted levels could exceed the ADI for toddlers and children【507526908888315†L108-L124】. A challenge study found hypersensitivity to a mixture of azo dyes including carmoisine in 5.1% of chronic urticaria patients【594584486185286†L171-L188】, suggesting that sensitive individuals may react.[avoid]
Frequently asked questions
Is E122 safe?
Our overall verdict for E122 (Azorubine, Carmoisine) is “Better avoided”, based on the most cautious of the major regulators’ positions — FDA: better avoided; WHO: safe in moderation; EFSA: safe in moderation; FSANZ: safe in moderation; Japan: better avoided; UK FSA: safe in moderation; Health Canada: better avoided.
Is E122 vegan, halal or gluten-free?
According to our ingredient data for Azorubine, Carmoisine — vegan: yes, vegetarian: yes, halal: yes, kosher: yes, gluten-free: yes, dairy-free: yes. Manufacturing sources can vary between products; check the label if it matters to you.
What is E122 and why is it used?
Azorubine (Carmoisine) is a synthetic azo dye used to give a red colour to foods, beverages, and some medicines. It is authorised in the EU/UK and Australia/New Zealand with maximum use levels and requires the EU hyperactivity warning label, but it is not permitted in foods in the United States, Canada, or Japan.
Does E122 contain allergens?
No known allergens are recorded for Azorubine, Carmoisine, though some people report sensitivity (azo dye sensitivity, aspirin/salicylate sensitivity).
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This page summarises publicly available regulatory assessments and research. It is general information, not medical advice. Sources: EFSA, FDA, WHO and the studies linked above.