Baby Safety / Compounds / Sunset yellow FCF (FD&C Yellow No. 6)

Is Sunset yellow FCF (FD&C Yellow No. 6) safe for babies and kids?

Moderate risk for kids

Infants are more vulnerable to Sunset yellow FCF (FD&C Yellow No. 6) 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 sunset yellow fcf (fd&c yellow no. 6)?

The IUPAC name is disodium;6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate.

Also known as: disodium;6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate, FD&C Yellow 6, DTXCID101131536, RefChem:1085314.

IUPAC name
disodium;6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
CAS number
2783-94-0
Molecular formula
C16H10N2Na2O7S2
Molecular weight
452.4 g/mol
SMILES
C1=CC(=CC=C1N=NC2=C(C=CC3=C2C=CC(=C3)S(=O)(=O)[O-])O)S(=O)(=O)[O-].[Na+].[Na+]
PubChem CID
17730

Risk for babies

Moderate risk

Infants are more vulnerable to Sunset yellow FCF (FD&C Yellow No. 6) 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 Sunset yellow FCF (FD&C Yellow No. 6), 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 Sunset yellow FCF (FD&C Yellow No. 6). The classifications differ — that's the data.

AgencyYearClassificationNotes
IARC2020Not evaluated by IARC for carcinogenicity — Sunset Yellow FCF (FD&C Yellow No. 6; E110) is an azo dye food colorant not classified as carcinogenic; one of the six colors in the Southampton hyperactivity study (McCann et al., Lancet 2007); associated with allergic-type reactions in aspirin-sensitive individuals; azo reductive cleavage products (sulfanilic acid and aminonaphthalenesulfonic acid) are not classified as carcinogens at food additive exposure levels; EU mandatory hyperactivity warning applies
EPA CTX / IARC—Group 3 - Not classifiable as to its carcinogenicity to humans
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 32 positive / 12 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 32 positive / 12 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 sunset yellow fcf (fd&c yellow no. 6)

  • 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 Sunset yellow FCF (FD&C Yellow No. 6):

  • 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 sunset yellow fcf (fd&c yellow no. 6) safe for kids?

Infants are more vulnerable to Sunset yellow FCF (FD&C Yellow No. 6) 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 sunset yellow fcf (fd&c yellow no. 6)?

Sunset yellow FCF (FD&C Yellow No. 6) 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 sunset yellow fcf (fd&c yellow no. 6)?

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 sunset yellow fcf (fd&c yellow no. 6)?

Sunset yellow FCF (FD&C Yellow No. 6) 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 Sunset yellow FCF (FD&C Yellow No. 6) in the baby app

Look up products containing sunset yellow fcf (fd&c yellow no. 6), compare to alternatives, and explore the full data record.

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Sources (1)
  1. Sunset Yellow FCF FD&C Yellow 6 E110 CI 15985 Monoazo; EFSA 2009 ADI Reduced 1 mg/kg/day from 2.5 Renal Tubular Toxicity; Southampton Six McCann Lancet 2007 Hyperactivity Warning EU; Aspirin Intolerance COX-1 Leukotriene Urticaria; Tobias Acid Sulfanilic Acid Azo Cleavage Non-Carcinogenic; EFSA High-Consuming Children ADI Approach Monitoring; FDA 21 CFR 74.706 Certified Color; Voluntary EU Reformulation Paprika Beta-Carotene Natural; Azo Dye Aerobic Resistant Anaerobic Reductive Ozonation; IARC Not Evaluated Not Carcinogen (2020) — 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 →