FD&C Red No. 40

Common names: Allura Red AC, Food Red 17, CI 16035 (Color Index Number), Red 40 Dye (common in the U.S.), E129 (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 Red No. 40, also known as Allura Red AC, is a synthetic dye commonly used in the food industry to impart a bright red color to products such as candies, baked goods, and beverages. Its stability under various processing conditions makes it a preferred choice for manufacturers seeking consistent and appealing coloration in consumables. The U.S. Food and Drug Administration (FDA) has approved its use in foods, provided it meets specified purity criteria.^[1]
Despite its widespread use, concerns have been raised regarding potential health effects associated with FD&C Red No. 40. Some studies suggest a link between artificial food dyes and behavioral issues in children, including hyperactivity and attention deficits. However, regulatory agencies continue to evaluate the evidence to determine appropriate usage guidelines.^[2]

Safety Overview

Regulatory Bodies

FDA (US)

The FDA has approved FD&C Red No. 40 for use in foods, drugs, and cosmetics, specifying that it must meet strict specifications and be free from impurities other than those named, to the extent that such other impurities may be avoided by good manufacturing practice.^[1]

Health Canada

Health Canada permits the use of Allura Red AC in food products, aligning with international safety assessments and regulations.^[3]

EFSA (Europe)

The EFSA has evaluated Allura Red AC (E129) and established an acceptable daily intake (ADI) of 7 mg/kg body weight. This assessment is based on available scientific data regarding its safety.^[4]

WHO (World Health Organization)

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has set an ADI for Allura Red AC at 0-7 mg/kg body weight, indicating that daily intake within this range is considered safe.^[5]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)

Current Status

Classified

EWG Rating

Environmental Working Group

EWG Rating: FD&C Red No. 40 has a hazard score of 4 according to the Environmental Working Group (EWG), indicating a moderate level of concern.^[6]
Level of Caution: EWG states that products containing this ingredient are allowed in EWG VERIFIED™ but must meet specific use restrictions and warnings.^[6]
Possible Health Risks: Concerns include enhanced skin absorption, neurotoxicity, endocrine disruption, bioaccumulation, and contamination risks.^[6]

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More about FD&C Red No. 40

Candies and Sweets: Gummy bears, hard candies, fruit-flavored chews
Beverages: Fruit punch, soda, sports drinks
Baked Goods and Desserts: Red velvet cake, frosted cookies, gelatin desserts

Historical Use

FD&C Red No. 40, also known as Allura Red AC, was approved for use in food products in 1971.^[7] It was introduced as a replacement for other synthetic red dyes that had been delisted due to safety concerns.^[8]

Current Exposure

Consumers are commonly exposed to FD&C Red No. 40 through various food products, including candies, beverages, and baked goods.^[9] Recent studies have assessed the exposure levels of this dye from over-the-counter medications, indicating its widespread presence in consumable products.^[10]

Hyperactivity in Children

Some studies have suggested a link between artificial food colorings, including Red No. 40, and increased hyperactive behavior in children. However, the evidence is not conclusive, and further research is needed to establish a definitive connection.^[11]

Allergic Reactions

In certain individuals, Red No. 40 may cause allergic reactions such as hives, facial swelling, or respiratory issues. These reactions are relatively rare and often occur in individuals with existing sensitivities.^[12]

Potential Carcinogenicity

While Red No. 40 has been approved for use by regulatory agencies, some animal studies have raised concerns about its potential carcinogenic effects. Nonetheless, current evidence does not conclusively demonstrate a cancer risk to humans at permitted exposure levels.^[13]

Behavioral Changes

There is limited evidence suggesting that Red No. 40 may contribute to behavioral changes such as irritability and depression in certain individuals. Further studies are required to confirm these findings and understand the underlying mechanisms.^[11]

Toxicological Studies

A lifetime feeding study involving 400 mice assessed the carcinogenicity of FD&C Red No. 40 by administering varying doses to different groups. The study aimed to evaluate potential tumor development associated with long-term exposure to the dye.^[13]

Long-Term Safety

The Acceptable Daily Intake (ADI) for FD&C Red No. 40 has been established based on toxicity studies in animals, indicating the maximum amount considered safe for daily consumption over a lifetime. Regulatory agencies have determined these ADIs to ensure consumer safety.^[12]

High-Risk Groups

Children are considered a high-risk group concerning exposure to FD&C Red No. 40, particularly due to their consumption of artificially colored foods and beverages. Studies have indicated that artificial food colorings may exacerbate hyperactive behaviors in children, especially those diagnosed with attention-deficit/hyperactivity disorder (ADHD).^[14]

Health Impacts

In pediatric populations, certain excipients, including artificial colorants like FD&C Red No. 40, have been associated with adverse reactions such as allergies and behavioral changes. The immature metabolic pathways in children may render them more susceptible to these effects, necessitating careful consideration of additive exposure in this vulnerable group.^[15]

Recommended Intake

Regulatory bodies, including the U.S. Food and Drug Administration (FDA), have established an Acceptable Daily Intake (ADI) for FD&C Red No. 40 at 7 milligrams per kilogram of body weight. This means that a person weighing 60 kg (approximately 132 pounds) can safely consume up to 420 mg of Red No. 40 per day.^[16]

General Safety Level

FD&C Red No. 40, also known as Allura Red AC, is a widely used synthetic colorant in various food and pharmaceutical products. While regulatory agencies have approved its use, recent studies suggest potential health concerns associated with its consumption.^[7]

Sensitive Individuals

Certain individuals may experience hypersensitivity reactions to FD&C Red No. 40, including allergic responses such as hives and facial swelling. Additionally, research has suggested a possible link between artificial food dyes and increased hyperactivity in children, especially those with Attention Deficit Hyperactivity Disorder (ADHD).^[9]

FAQ

Is FD&C Red 40 safe?

FD&C Red 40 is considered safe by the FDA and other regulatory agencies, but some studies suggest potential links to hyperactivity in sensitive individuals.

What is FD&C Red Color No. 40?

FD&C Red 40 is a synthetic food dye derived from petroleum, commonly used in processed foods, beverages, and cosmetics.

Why isn't Red 40 banned?

Red 40 is not banned because regulatory agencies, including the FDA and EFSA, have determined it to be safe for consumption based on current scientific evidence.

References

U.S. Food and Drug Administration (FDA). (2023). CFR - Code of Federal Regulations Title 21. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=74.340 ↩︎
Healthline. (2023). Red Dye 40: Safety, Side Effects, and Food List. Available at: https://www.healthline.com/nutrition/red-dye-40 ↩︎
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 ↩︎
European Food Safety Authority (EFSA). (2009). Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal, 7(11), 1327. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/1327 ↩︎
World Health Organization (WHO). (2011). Safety evaluation of certain food additives. WHO Food Additives Series: 64. Available at: https://apps.who.int/iris/handle/10665/44521 ↩︎
Environmental Working Group (EWG). (n.d.). FD&C Red No. 40 (CI 16035). Available at: https://www.ewg.org/skindeep/ingredients/702431-FDC_RED_NO_40_CI_16035/ ↩︎
Choi, J., Eom, S., Kim, J., Lee, S., Kim, Y., Choi, D., ... & Park, J. (2022). Chronic exposure to synthetic food colorant Allura Red AC promotes susceptibility to intestinal inflammation by disrupting gut homeostasis. Nature Communications, 13(1), 1-14. Available at: https://www.nature.com/articles/s41467-022-35309-y ↩︎
Food Additives. (2016). SpringerLink. Available at: https://link.springer.com/chapter/10.1007/978-3-319-12472-8_6 ↩︎
Stevens, L. J., Kuczek, T., Burgess, J. R., Hurt, E., & Arnold, L. E. (2011). Dietary sensitivities and ADHD symptoms: thirty-five years of research. Clinical Pediatrics, 50(4), 279-293. Available at: https://link.springer.com/chapter/10.1007/978-3-030-30402-7_15 ↩︎
Exposures to FD&C synthetic color additives from over-the-counter medications. (2022). Journal of Exposure Science & Environmental Epidemiology. Available at: https://www.nature.com/articles/s41370-022-00418-9 ↩︎
Stevens, L. J., Kuczek, T., Burgess, J. R., Hurt, E., & Arnold, L. E. (2013). Artificial Food Colors and Attention-Deficit/Hyperactivity Symptoms: Conclusions to Dye for. Neurotherapeutics, 10(4), 791-799. Available at: https://link.springer.com/article/10.1007/s13311-012-0133-x ↩︎
Neltner, T. G., Kulkarni, N. R., Alger, H. M., Maffini, M. V., Bongard, E. D., & Fortin, N. D. (2013). Navigating the U.S. Food Additive Regulatory Program. Comprehensive Reviews in Food Science and Food Safety, 12(4), 500-520. Available at: https://link.springer.com/content/pdf/10.1186/s12940-022-00849-9.pdf ↩︎
Andrews, D. F., & Herzberg, A. M. (1985). Time to Death and Type of Death in Mice Receiving Various Doses of Red Dye No. 40. In Data (pp. 239-244). Springer, New York, NY. Available at: https://link.springer.com/chapter/10.1007/978-1-4612-5098-2_43 ↩︎
Food Color and Autism: A Meta-Analysis. (2019). SpringerLink. Available at: https://link.springer.com/chapter/10.1007/978-3-030-30402-7_15 ↩︎
Excipients in Pediatric Formulations: Biopharmaceutical and Toxicological Considerations. (2015). SpringerLink. Available at: https://link.springer.com/chapter/10.1007/978-3-319-20206-8_16 ↩︎
Centers for Disease Control and Prevention. (2015). Determination of Red Food Coloring in Commercial Beverages. Available at: https://stacks.cdc.gov/view/cdc/58356/cdc_58356_DS8.pdf ↩︎

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