Baby Safety / Compounds / Carmoisine (Azorubine; E122)

Is Carmoisine (Azorubine; E122) safe for babies and kids?

Elevated risk for kids

Infants are more vulnerable to Carmoisine (Azorubine; E122) than children or adults due to immature hepatic/renal clearance, higher intake-to-body-weight ratio, rapid organ development, and increased gastrointestinal absorption.

What is carmoisine (azorubine; e122)?

The IUPAC name is disodium;4-hydroxy-3-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-1-sulfonate.

Also known as: disodium;4-hydroxy-3-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-1-sulfonate, azorubine, RefChem:1077425, DTXCID001437202.

IUPAC name: disodium;4-hydroxy-3-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-1-sulfonate
CAS number: 3567-69-9
Molecular formula: C20H12N2Na2O7S2
Molecular weight: 502.4 g/mol
SMILES: C1=CC=C2C(=C1)C(=CC=C2S(=O)(=O)[O-])N=NC3=C(C4=CC=CC=C4C(=C3)S(=O)(=O)[O-])O.[Na+].[Na+]
PubChem CID: 19118

Risk for babies

Elevated risk

Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.

What to do: Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Risk for pregnant and nursing people

Context-dependent

Pregnancy alters the metabolism and distribution of Carmoisine (Azorubine; E122), potentially increasing fetal exposure. The developing embryo/fetus is vulnerable during organogenesis (weeks 3-8) and neurological development. Placental transfer should be assumed.

No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.

What to do: Minimize exposure during pregnancy and lactation. Consult healthcare provider regarding specific risks. Consider alternative products with lower hazard profiles.

Regulatory consensus

4 regulatory and scientific bodies have classified Carmoisine (Azorubine; E122). The classifications differ — that's the data.

Agency	Year	Classification
IARC	2009	Not evaluated by IARC for carcinogenicity — Carmoisine (also called Azorubine; E122; CAS 3567-69-9; disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo)naphthalene-1-sulfonate; Acid Red 14) is a synthetic monoazo dye producing a deep red-crimson color; it is permitted in the EU but banned in the United States, Canada, Japan, Australia/New Zealand, and Norway; Carmoisine was present in BOTH Mix A and Mix B of the Southampton 2007 hyperactivity study (McCann et al., Lancet) — the study showed statistically significant increases in hyperactivity in 3-year-old and 8-9-year-old children; EU Regulation 1333/2008 mandates a warning label ('may have an adverse effect on activity and attention in children'); EFSA ADI: 4 mg/kg/day (2009); no recognized carcinogenicity classification exists
EPA CTX / IARC	—	Group 3 - Not classifiable as to its carcinogenicity to humans
EPA CTX / Genetox	—	Genotoxicity: positive (Ames: positive, 1 positive / 10 negative reports)
EPA CTX / Genetox	—	Genotoxicity: positive (Ames: positive, 1 positive / 10 negative reports)

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where kids encounter carmoisine (azorubine; e122)

Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
Occupational Environments — Factories, Warehouses, Transportation vehicles
Consumer Products — food products, candy, beverages, cosmetics, supplements

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Carmoisine (Azorubine; E122):

Fragrance-free formulations
Trade-offs: Consumer preference for scented products

Relative cost: Lower (ingredient elimination)
Essential oil-based fragrances (with disclosure)
Trade-offs: Natural does not mean safe — many essential oils are skin sensitizers

Relative cost: 2-5× conventional

Frequently asked questions

Is carmoisine (azorubine; e122) safe for kids?

What products contain carmoisine (azorubine; e122)?

Carmoisine (Azorubine; E122) appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); food products (Consumer products).

What should I do if my child is exposed to carmoisine (azorubine; e122)?

Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Why do regulators disagree about carmoisine (azorubine; e122)?

Carmoisine (Azorubine; E122) has been classified by 4 agencies including IARC, EPA CTX / IARC, EPA CTX / Genetox, EPA CTX / Genetox, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.

See Carmoisine (Azorubine; E122) in the baby app

Look up products containing carmoisine (azorubine; e122), compare to alternatives, and explore the full data record.

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Sources (1)

Carmoisine Azorubine E122 CAS 3567-69-9 Acid Red 14 CI Food Red 3 Monoazo Disulfonate; EFSA 2009 ADI 4 mg/kg/day NOAEL 600 mg/kg/day Rat 90-day Safety Factor 100; Southampton 2007 McCann Lancet Mix A 14.3mg Mix B 7.5mg Both Mixtures; Hyperactivity Children 3yr 8-9yr CGHAS Statistically Significant; EU Regulation 1333/2008 Mandatory Warning Label; Banned US FDA Canada Japan Australia NZ Norway; UK FSA 2009 Voluntary Reformulation Natural Colorants; Azo Bond Gut Reductase 4-Aminonaphthalene-1-Sulfonate Metabolites; Aspirin Cross-Reactivity Azo Intolerance; WWTP Limited Biodegradation Sludge Adsorption (2009) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →