Baby Safety / Compounds / Erythrosine (FD&C Red No. 3)

Is Erythrosine (FD&C Red No. 3) safe for babies and kids?

Moderate risk for kids

Infants are more vulnerable to Erythrosine (FD&C Red No. 3) 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 erythrosine (fd&c red no. 3)?

The IUPAC name is 3',6'-dihydroxy-2',4',5',7'-tetraiodospiro[2-benzofuran-3,9'-xanthene]-1-one.

Also known as: 3',6'-dihydroxy-2',4',5',7'-tetraiodospiro[2-benzofuran-3,9'-xanthene]-1-one, ERYTHROSINE, E127, FD & C red no. 3.

IUPAC name
3',6'-dihydroxy-2',4',5',7'-tetraiodospiro[2-benzofuran-3,9'-xanthene]-1-one
CAS number
16423-68-0
Molecular formula
C20H8I4O5
Molecular weight
835.9 g/mol
SMILES
C1=CC=C2C(=C1)C(=O)OC23C4=CC(=C(C(=C4OC5=C(C(=C(C=C35)I)O)I)I)O)I
PubChem CID
3259

Risk for babies

Moderate risk

Infants are more vulnerable to Erythrosine (FD&C Red No. 3) than children or adults due to immature hepatic/renal clearance, higher intake-to-body-weight ratio, rapid organ development, and increased gastrointestinal absorption.

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

High risk

Pregnancy alters the metabolism and distribution of Erythrosine (FD&C Red No. 3), potentially increasing fetal exposure. The developing embryo/fetus is vulnerable during organogenesis (weeks 3-8) and neurological development. Placental transfer should be assumed.

Known reproductive toxicant (GHS H360) or confirmed endocrine disruptor. Placental transfer is presumed. Fetal exposure during critical developmental windows may cause structural malformations, growth restriction, or functional deficits.

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

Regulatory consensus

7 regulatory and scientific bodies have classified Erythrosine (FD&C Red No. 3). The classifications differ — that's the data.

AgencyYearClassificationNotes
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 37 positive / 13 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 37 positive / 13 negative reports)
EPA CTX / Skin-Eye—skin sensitisation: in vivo (LLNA): Not likely to be sensitizing (score: low)
EPA CTX / Skin-Eye—skin sensitisation: in vivo (non-LLNA): High Frequency of Sensitization (score: high)
EPA CTX / Skin-Eye—skin sensitisation: Not likely to be sensitizing (score: low)
EPA CTX / Skin-Eye—eye irritation: in vivo: Studies Indicate No Significant Irritation (score: low)
EPA CTX / Skin-Eye—skin irritation: in vivo: Studies Indicate No Significant Irritation (score: low)

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 erythrosine (fd&c red no. 3)

  • 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 Erythrosine (FD&C Red No. 3):

  • Water-based formulations where feasible
    Trade-offs: Longer drying time. May not achieve same performance in all applications.
    Relative cost: 0.8-1.5×
  • Bio-based solvents (d-limonene, ethyl lactate)
    Trade-offs: Higher cost. Flammability concerns with some bio-solvents.
    Relative cost: 2-5× conventional

Frequently asked questions

Is erythrosine (fd&c red no. 3) safe for kids?

Infants are more vulnerable to Erythrosine (FD&C Red No. 3) than children or adults due to immature hepatic/renal clearance, higher intake-to-body-weight ratio, rapid organ development, and increased gastrointestinal absorption.

What products contain erythrosine (fd&c red no. 3)?

Erythrosine (FD&C Red No. 3) 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 erythrosine (fd&c red no. 3)?

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 erythrosine (fd&c red no. 3)?

Erythrosine (FD&C Red No. 3) has been classified by 7 agencies including EPA CTX / Genetox, EPA CTX / Genetox, EPA CTX / Skin-Eye, EPA CTX / Skin-Eye, EPA CTX / Skin-Eye, 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 Erythrosine (FD&C Red No. 3) in the baby app

Look up products containing erythrosine (fd&c red no. 3), compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (2)
  1. US FDA: Revocation of Authorization for FD&C Red No. 3 (Erythrosine) in Food and Ingested Drugs — Delaney Clause Application, Thyroid Tumor Evidence in Male Rats, Compliance Timeline, and Continued Cosmetic Permissions (January 2025) (2025) — regulatory
  2. EFSA Panel on Food Additives: Re-evaluation of Erythrosine (E127) — ADI 0.1 mg/kg bw/day, Thyroid Iodine Loading Mechanism Assessment, Dietary Exposure in EU, and Continued E127 Authorization (EFSA Journal 2011;9(3):1854) (2011) — 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 →