Yellow Dye 5 is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Yellow Dye 5 was one of six dyes studied in the landmark 2007 McCann et al. study in The Lancet. The study found statistically significant increases in hyperactivity in children ages 3 and 8–9 given a mixture containing tartrazine and sodium benzoate. EFSA reviewed the evidence and confirmed the effect was real, mandating the EU warning label from 2010. A 2012 review in Neurotherapeutics (Arnold et al.) confirmed that artificial food colors including tartrazine have a small but statistically significant adverse effect on children's behavior that is not confined to those with diagnosed ADHD. Tartrazine is one of the most documented causes of food dye hypersensitivity. Cross-reactivity with aspirin (acetylsalicylic acid, ASA) is well established in allergy literature: individuals with aspirin hypersensitivity have elevated risk of reacting to tartrazine. Symptoms include urticaria, angioedema, rhinitis, and in rare cases anaphylaxis. Prevalence of tartrazine sensitivity is estimated at 0.1% of the population but higher in aspirin-sensitive individuals. Because of this known hypersensitivity risk, the FDA specifically requires Yellow No. 5 to be declared by name on US food labels — an exceptional requirement not applied to most other additives, reflecting the FDA's acknowledgment of this real clinical concern. EFSA's 2009 re-evaluation found no evidence of genotoxicity in standard test systems at food use levels, setting an ADI of 7.5 mg/kg body weight, but noted in vitro evidence at higher doses. In April 2025, the FDA announced plans to phase out Yellow 5 along with other petroleum-based dyes.
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