FDC Blue no 1

Common names: Brilliant Blue FCF, C.I. 42090, Acid Blue 9, E133 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 16, 2025
Medically reviewed by Dr. William Lin, MD
FD&C Blue No. 1, also known as Brilliant Blue FCF, is a synthetic dye widely used in the food industry to impart a vibrant blue hue to various products. It is commonly found in confections, beverages, dairy products, and baked goods, valued for its stability under light and heat, as well as its ability to blend with other dyes to produce a spectrum of colors. Approved by the U.S. Food and Drug Administration (FDA) for use in foods, drugs, and cosmetics, its application is subject to specific regulatory standards to ensure consumer safety.[1]
Despite its widespread use, FD&C Blue No. 1 has been associated with certain health concerns. While key studies in rats and mice did not find it to be toxic, an unpublished study suggested a potential link to kidney tumors in mice, and preliminary in vitro research raised questions about possible effects on nerve cells.[1] Additionally, the dye has been known to cause hypersensitivity reactions in some individuals. Although it may not be carcinogenic, further confirmatory studies are recommended to fully assess its safety profile.[1]

Safety Overview

Regulatory Bodies

FDA (US)
FD&C Blue No. 1 is permanently listed and approved for use in foods, drugs, and cosmetics, with certification required for each batch.[2]
Health Canada
Brilliant Blue FCF is listed as a permitted food color in Canada, allowed at Good Manufacturing Practice (GMP) levels in various food categories.[3]
EFSA (Europe)
Brilliant Blue FCF (E133) is authorized for use in the European Union, with specific applications and maximum permitted levels outlined in EU regulations.[4]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated Brilliant Blue FCF and established an acceptable daily intake (ADI) of 0–6 mg/kg body weight.[5]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
​FD&C Blue No. 1, also known as Brilliant Blue FCF, is a synthetic dye approved by the U.S. Food and Drug Administration (FDA) for use in foods, drugs, and cosmetics. However, it is not classified as “Generally Recognized As Safe” (GRAS). Instead, it is subject to certification for each batch to ensure compliance with safety standards.[2]

EWG Rating

Environmental Working Group
  • EWG Rating: The Environmental Working Group (EWG) assigns FD&C Blue No. 1, also known as Brilliant Blue FCF or CI 42090, a rating that varies based on its usage, with higher concern for inhalable products due to respiratory risks.[6]
  • Level of Caution: EWG recommends caution when using products containing this dye, especially in forms that are inhalable, due to potential respiratory concerns.[7]
  • Possible Health Risks: Potential health risks associated with FD&C Blue No. 1 include enhanced skin absorption, neurotoxicity, endocrine disruption, and organ system toxicity.[7]
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More about FDC Blue no 1

  • Beverages: Sports drinks, soft drinks, flavored water
  • Confections & Desserts: Candy, ice cream, frosting
  • Processed & Packaged Foods: Breakfast cereals, gelatin desserts, snack cakes

Historical Use
FD&C Blue No. 1, also known as Brilliant Blue FCF, was among the original synthetic colorants approved under the U.S. Pure Food and Drug Act of 1906. By 1931, it remained one of the six colors still approved for use in foods.[8]
Current Exposure
Consumers are frequently exposed to FD&C Blue No. 1 through various products, including confections, beverages, dairy products, and baked goods. A study analyzing approximately 600 foods found that this dye is commonly present in these categories.[9]

Neurotoxicity
In vitro studies have shown that FD&C Blue No. 1 can inhibit neurite growth and act synergistically with L-glutamic acid, suggesting potential neurotoxic effects.[10]
Allergic Reactions
There have been occasional reports of hypersensitivity reactions, such as skin irritations and bronchial constriction, associated with the consumption of FD&C Blue No. 1.[1]
Behavioral Effects in Children
Some studies have indicated a possible link between synthetic food dyes, including FD&C Blue No. 1, and hyperactivity or other behavioral issues in children, though individual sensitivity varies.[11]
Potential Carcinogenicity
While key studies in rats and mice did not find FD&C Blue No. 1 to be toxic, an unpublished study suggested a potential link to kidney tumors in mice, warranting further research.[1]

Toxicological Studies
In animal studies, FD&C Blue No. 1 exhibited low acute toxicity, with high oral LD50 values indicating low toxicity.[1] However, in vitro studies have shown that FD&C Blue No. 1 can inhibit neurite growth and act synergistically with L-glutamic acid, suggesting potential neurotoxic effects.[10]
Long-Term Safety
Long-term studies in rodents have not demonstrated significant carcinogenic effects from FD&C Blue No. 1 consumption.[1] However, an unpublished study suggested the possibility that Blue 1 caused kidney tumors in mice, and a preliminary in vitro study raised questions about possible effects on nerve cells.[1]

High-Risk Groups
Children are particularly vulnerable to the effects of synthetic food dyes, including FD&C Blue No. 1, due to their developing nervous systems and higher consumption rates relative to body weight.[12]
Health Impacts
Exposure to FD&C Blue No. 1 has been associated with neurobehavioral effects in children, such as hyperactivity and attention deficits, with some studies indicating that certain children may be more sensitive to these dyes.[12]

Recommended Intake
Recommended Intake: The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has established an acceptable daily intake (ADI) for FD&C Blue No. 1, also known as Brilliant Blue FCF, of 0–6 mg/kg body weight.[5] In contrast, the U.S. Food and Drug Administration (FDA) suggests a higher ADI of up to 12 mg/kg body weight for this color additive.[1]

General Safety Level
FD&C Blue No. 1 is considered safe for most individuals and has a low likelihood of causing allergic reactions, as studies have not consistently linked it to widespread hypersensitivity.[1] Regulatory bodies such as the FDA and EFSA classify it as a safe food additive within established intake limits.[4]
Sensitive Individuals
Some individuals may experience hypersensitivity reactions, including skin rashes, asthma-like symptoms, or anaphylaxis, particularly those with pre-existing dye allergies.[1] Case reports suggest that FD&C Blue No. 1 can trigger allergic responses in rare instances, especially in people with a history of sensitivity to synthetic dyes.[1]

FAQ

Is FD&C Blue 1 safe?

FD&C Blue 1 is generally considered safe for most people when used within approved limits.

What are the hazards of FD&C Blue #1?

Some studies suggest it may cause allergic reactions or hyperactivity in sensitive individuals.

What does Blue 1 do to the human body?

Blue 1 adds color to foods and cosmetics but may cause mild side effects in rare cases.

Can dogs have FD&C Blue #1?

While not toxic, artificial dyes like Blue 1 are best avoided in a dog's diet.

References

  1. Center for Science in the Public Interest 2010 Food Dyes A Rainbow of Risks Available at: https://www.cspinet.org/sites/default/files/attachment/food-dyes-rainbow-of-risks.pdf ↩︎
  2. US Food and Drug Administration n.d. Code of Federal Regulations Title 21 - FDC Blue No. 1 Brilliant Blue FCF Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-B/section-74.1101 ↩︎
  3. European Food Safety Authority n.d. Scientific Opinion on the re-evaluation of Brilliant Blue FCF E 133 as a food additive Available at: https://www.efsa.europa.eu/en/efsajournal/pub/1853 ↩︎
  4. World Health Organization n.d. Brilliant Blue FCF Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3309 ↩︎
  5. Health Canada n.d. List of Permitted Colouring Agents Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html ↩︎
  6. Environmental Working Group n.d. CI 42090 FDC Blue No. 1 or DC Blue No. 4 Available at: https://www.ewg.org/skindeep/ingredients/702408-CI_42090_FDC_Blue_No_1_or_DC_Blue_No_4/ ↩︎
  7. Environmental Working Group n.d. Ci 42090 FdC Blue No. 1 Or DC Blue No. 4 Skin Deep Available at: https://www.ewg.org/skindeep/ingredients/702408-CI_42090_FDC_Blue_No_1_or_DC_Blue_No_4/ ↩︎
  8. US Food and Drug Administration n.d. Color Additives History Available at: https://www.fda.gov/industry/color-additives/color-additives-history ↩︎
  9. Doell D. L. Folmer D. E. Lee H. S. Butts K. M. Carberry S. E. 2016 Exposure estimate for FDC color additives for the US population Food Additives and Contaminants Part A 33(5) 782-797 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4975380/ ↩︎
  10. Kus E. Eroglu H. E. 2015 Genotoxic and Cytotoxic Effects of Sunset Yellow and Brilliant Blue Colorant Food Additives on Human Blood Lymphocytes Pakistan Journal of Pharmaceutical Sciences 28(1) 227-230 Available at: https://pubmed.ncbi.nlm.nih.gov/25553699/ ↩︎
  11. Office of Environmental Health Hazard Assessment OEHHA 2020 Food Dyes Health Effects Assessment Reproductive and Cancer Hazard Assessment Branch Available at: https://oehha.ca.gov/media/downloads/risk-assessment/report/fooddyesassessmentdraft082820.pdf ↩︎

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