Quinoline Yellow
Quinoline Yellow

Quinoline Yellow

Common names: FD&C Yellow No. 10Acid Yellow 3C.I. 47005E104 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Risky
Published by Jordana Tobelem, RD, LDN — Last Updated on May 6, 2025
Medically reviewed by Dr. William Lin, MD
FD&C Yellow No. 10, also known as D&C Yellow No. 10 or Quinoline Yellow, is a synthetic dye primarily used in pharmaceutical and cosmetic products to provide a lemon-yellow color to tablets, capsules, and topical formulations. Although not approved for food use in the United States, it is permitted in certain countries, including those in the European Union, under the designation E104. The dye is appreciated for its water solubility and stability under processing conditions.[1]
Although generally considered safe for its intended uses, FD&C Yellow No. 10 has been associated with potential hypersensitivity reactions in some individuals. One study noted that approximately 13% of patients tested showed allergic reactions, such as urticaria flare-ups, when exposed to quinoline yellow. Despite these findings, such reactions are rare, and regulatory agencies continue to evaluate its safety for public use.[2]

Safety Overview

Regulatory Bodies

FDA (US)
Quinoline Yellow is permanently listed for use in drugs, cosmetics, and certain medical devices, with certification required; however, it is not approved for use in food products.[3]
Health Canada
Quinoline Yellow is permitted for use in drugs and cosmetics but is not listed among the permitted food color additives, indicating it is not approved for use in foods.[4]
EFSA (Europe)
Quinoline Yellow (E104), the European equivalent of D&C Yellow No. 10, is approved for use as a food additive in the European Union, subject to specific usage limits.[5]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives has evaluated Quinoline Yellow and established an Acceptable Daily Intake (ADI) of 0-3 mg/kg bw, reflecting its assessment of the dye’s safety for use in foods.[6]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
FD&C Yellow No. 10 is not classified as GRAS (Generally Recognized As Safe) by the U.S. Food and Drug Administration (FDA). Instead, it is listed as a certified color additive permitted only for specific uses, such as in drugs and cosmetics, but not approved for use in food. Its usage requires batch certification by the FDA to ensure safety and compliance with regulatory standards.[3]

EWG Rating

Environmental Working Group
  • EWG Rating: D&C Yellow No. 10 (CI 47005) receives a rating that varies from 'Restricted' to 'Unacceptable' based on its usage, particularly in aerosol products where respiratory concerns are elevated.[7]
  • Level of Caution: The ingredient is associated with high use restrictions due to regulatory limitations and potential contamination concerns. [7]
  • Possible Health Risks: Potential health risks include low to moderate concerns for allergies and immunotoxicity, as well as low concerns for cancer and developmental or reproductive toxicity.[7]
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More about Quinoline Yellow

  • Beverages (outside the U.S.): Lemon-lime soft drinks, energy drinks, fruit-flavored beverages
  • Confectionery: Hard candies, jellies, chewing gum
  • Processed Foods: Flavored gelatin, dessert powders, powdered drink mixes. Note: FD&C Yellow No. 10 (Quinoline Yellow or E104) is not approved for use in foods in the United States but is permitted in various countries such as those in the EU, where it may appear in the above food categories.

Historical Use
FD&C Yellow No. 10, also known as Quinoline Yellow, has been used since the early 20th century as a synthetic dye for coloring pharmaceutical and cosmetic products.[1] It was never approved for food use in the U.S., but saw historical application in food items in other regions under different regulatory codes.[2]
Current Exposure
Currently, exposure in the United States is limited to use in pharmaceuticals and personal care items such as tablets, creams, and mouthwashes.[1] In regions where Quinoline Yellow (E104) is allowed in food, like the EU, it appears in beverages, candies, and dessert powders.[2]

Hyperactivity in Children
Some studies have linked synthetic dyes like FD&C Yellow No. 10 to increased hyperactivity in children, though results remain mixed and not all studies find a significant effect.[8]
Allergic Reactions
FD&C Yellow No. 10 may trigger allergic responses, such as skin rashes or asthma-like symptoms, particularly in individuals with dye sensitivities.[9]
Potential Carcinogenicity
Limited data suggest that synthetic food dyes could pose carcinogenic risks, though FD&C Yellow No. 10 specifically lacks definitive evidence for such effects.[1]

Toxicological Studies
A comprehensive study involving rats administered D&C Yellow No. 10 at dietary levels up to 5% (equivalent to 2500 mg/kg body weight/day) identified reduced pup viability and lower weight gains during lactation at doses of 0.5% (250 mg/kg bw/day) and above. These findings suggest potential adverse effects on reproduction and development at high exposure levels.[10]
Long-Term Safety
The same study established a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw/day for D&C Yellow No. 10, indicating that long-term consumption below this threshold is not associated with observable adverse effects in the tested animal model.[10]

High-Risk Groups
Children, especially those with Attention Deficit Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD), are considered high-risk groups for adverse effects from synthetic food dyes, including FD&C Yellow No. 10.[11]
Health Impacts
Research suggests that exposure to synthetic food dyes may worsen behavioral symptoms in sensitive children, with some studies indicating a link between dye consumption and increased hyperactivity.[12]

Recommended Intake
The European Food Safety Authority (EFSA) established an Acceptable Daily Intake (ADI) for Quinoline Yellow (E104, equivalent to FD&C Yellow No. 10) at 0.5 mg/kg body weight per day, based on toxicity studies identifying a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg bw/day in animal models.[5]

General Safety Level
FD&C Yellow No. 10 is generally considered safe for the majority of the population when used within regulatory limits, with no widespread reports of allergic reactions under normal conditions of exposure.[5]
Sensitive Individuals
In rare cases, individuals with sensitivities to azo or quinoline-based dyes have reported hypersensitivity reactions, such as urticaria or exacerbated asthma symptoms following ingestion or dermal contact.[13]

FAQ

What is quinoline yellow made of?

Quinoline yellow is a synthetic dye made from quinoline compounds derived from coal tar.

What is quinoline yellow?

Quinoline yellow is an artificial food coloring used to give products a yellow-green hue.

Why is quinoline yellow added to foods?

Quinoline yellow is added to foods to enhance or restore color and improve visual appeal.

References

  1. National Center for Biotechnology Information (n.d.) 'D&C Yellow No. 10', PubChem. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/D_C-Yellow-No.-10 ↩︎
  2. National Center for Biotechnology Information (n.d.) 'C.I. Food Yellow 13', PubChem. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/C.I.-Food-Yellow-13 ↩︎
  3. U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21 - D&C Yellow No. 10. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-B/section-74.1710 ↩︎
  4. Health Canada. (2024). 'List of Permitted Food Colours (Lists of Permitted Food Additives)'. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html ↩︎
  5. European Food Safety Authority. (2009). Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive. EFSA Journal, 7(11):1329. Available at: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1329 ↩︎
  6. World Health Organization. (2016). Quinoline Yellow. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3466 ↩︎
  7. Environmental Working Group (n.d.) 'D&C Yellow No. 10 (CI 47005)', EWG's Skin Deep. Available at: https://www.ewg.org/skindeep/ingredients/701829-DC_Yellow_No_10_CI_47005/ ↩︎
  8. Stevens, L.J., Burgess, J.R., Stochelski, M.A. and Kuczek, T. (2013). 'Amount of artificial food colors in commonly consumed beverages and potential behavioral implications for consumption in children', Clinical Pediatrics, 52(10), pp. 1000-1008. Available at: https://pubmed.ncbi.nlm.nih.gov/24037921/ ↩︎
  9. McCann, D. et al. (2007) 'Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial', The Lancet, 370(9598), pp. 1560-1567. Available at: https://pubmed.ncbi.nlm.nih.gov/17825405/ ↩︎
  10. European Commission (2021) 'Opinion on Acid Yellow 3 - C054 (CAS No. 8004-92-0, EC. No 305-897-5)', Scientific Committee on Consumer Safety. Available at: https://health.ec.europa.eu/document/download/5d0b824f-f85c-4b2d-a66c-694d274d1ff1_en ↩︎
  11. Nigg, J.T., Lewis, K., Edinger, T. and Falk, M. (2012). 'Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives', Journal of the American Academy of Child & Adolescent Psychiatry, 51(1), pp. 86-97. Available at: https://pubmed.ncbi.nlm.nih.gov/22176942/ ↩︎
  12. Stevens, L.J., Kuczek, T., Burgess, J.R., Hurt, E. and Arnold, L.E. (2011). 'Dietary sensitivities and ADHD symptoms: Thirty-five years of research', Clinical Pediatrics, 50(4), pp. 279-293. Available at: https://pubmed.ncbi.nlm.nih.gov/21127082/ ↩︎
  13. Center for Science in the Public Interest. (2024). Synthetic food dyes: A rainbow of risks. Available at: https://www.cspinet.org/cspi-news/synthetic-food-dyes-rainbow-risks ↩︎

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