Baby Safety / Compounds / Amaranth (FD&C Red No. 2; E123)

Is Amaranth (FD&C Red No. 2; E123) safe for babies and kids?

Elevated risk for kids

Infants are more vulnerable to Amaranth (FD&C Red No. 2; E123) 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 amaranth (fd&c red no. 2; e123)?

The IUPAC name is trisodium;3-hydroxy-4-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-2,7-disulfonate.

Also known as: trisodium;3-hydroxy-4-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-2,7-disulfonate, AMARANTH, Acid red 27, Azorubin S.

IUPAC name
trisodium;3-hydroxy-4-[(4-sulfonatonaphthalen-1-yl)diazenyl]naphthalene-2,7-disulfonate
CAS number
915-67-3
Molecular formula
C20H11N2Na3O10S3
Molecular weight
604.5 g/mol
SMILES
C1=CC=C2C(=C1)C(=CC=C2S(=O)(=O)[O-])N=NC3=C4C=CC(=CC4=CC(=C3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
PubChem CID
13506

Risk for babies

Elevated risk

Infants are more vulnerable to Amaranth (FD&C Red No. 2; E123) 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

Context-dependent

Pregnancy alters the metabolism and distribution of Amaranth (FD&C Red No. 2; E123), 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 Amaranth (FD&C Red No. 2; E123). The classifications differ — that's the data.

AgencyYearClassificationNotes
IARC1986Group 3 — Not classifiable as to its carcinogenicity to humans (IARC Monograph Volume 40, 1986) — inadequate evidence of carcinogenicity in both humans and experimental animals; the Soviet/Eastern Bloc animal studies that initially suggested carcinogenicity (bladder, uterine, and mammary tumors in rats) were not replicated under rigorous conditions; the US FDA banned Amaranth (FD&C Red No. 2) in 1976 on precautionary grounds based on these Soviet studies before IARC concluded its evaluation; the EU permits Amaranth (E123) for very limited uses (fish roe/caviar substitutes, aperitif wines, spirits, and blood/liver products); IARC Group 3 does not indicate the compound is safe — only that available evidence was inadequate to determine carcinogenicity; no subsequent IARC reassessment has been published since 1986
EPA CTX / IARC—Group 3 - Not classifiable as to its carcinogenicity to humans
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 3 positive / 13 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 3 positive / 13 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 amaranth (fd&c red no. 2; e123)

  • 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 Amaranth (FD&C Red No. 2; E123):

  • Natural dyes (indigo, madder, weld) where applicable
    Trade-offs: Lower colorfastness. Limited palette. Higher cost per unit.
    Relative cost: 2-5× conventional
  • Reactive dyes with lower aquatic toxicity
    Trade-offs: Not suitable for all fiber types
    Relative cost: 1.2-2×

Frequently asked questions

Is amaranth (fd&c red no. 2; e123) safe for kids?

Infants are more vulnerable to Amaranth (FD&C Red No. 2; E123) 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 amaranth (fd&c red no. 2; e123)?

Amaranth (FD&C Red No. 2; E123) 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 amaranth (fd&c red no. 2; e123)?

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 amaranth (fd&c red no. 2; e123)?

Amaranth (FD&C Red No. 2; E123) 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.

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Sources (1)
  1. Amaranth FD&C Red No 2 E123 CAS 915-67-3 CI Food Red 9 Acid Red 27 Trisulfonated Monoazo; IARC Monograph Vol 40 1986 Group 3 Not Classifiable Inadequate Evidence Humans Animals; USSR Soviet Studies 1970s Mammary Uterine Bladder Tumors Female Wistar Rats Methodological Concerns Not Replicated; FDA Ban January 1976 Precautionary Delaney Clause Alexander Schmidt; EFSA 2010 ADI 0.5 mg/kg/day IARC Group 3 Confirmed; EU E123 Restricted: Imitation Caviar 150mg/kg Aperitif Wines 30mg/L Blood Liver Sausage; Banned US Canada Japan Russia; Not Southampton Hyperactivity Study; Poor GI Absorption <5% Trisulfonate; Azo Bond Gut Reductase Aromatic Amine Metabolites (2010) — 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 →