Regulatory Update

Food Dyes and Children: What Parents Need to Know

The FDA announced in 2025 it is phasing out six petroleum-derived synthetic dyes by 2027. Europe has required warning labels on products containing these same dyes since 2010. A landmark 2007 study triggered all of it. Here is the full picture — the science, the regulations, and what it means for what your children eat.

February 12, 20268 min readSources: FDA, EFSA, The Lancet
Gummy bears and colorful candy containing synthetic food dyes

Bottom line

Six synthetic food dyes — Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 — are being phased out by the FDA by end of 2027. The European Union has required a mandatory warning label ("may have an adverse effect on activity and attention in children") on all products containing five of these dyes since 2010. California passed a law in 2023 requiring similar warnings starting in 2027. The underlying concern is a possible link between these dyes and hyperactivity in sensitive children.

The McCann study: the research that changed regulations

In September 2007, researchers led by Jim McCann at the University of Southampton published a randomized, double-blind, placebo-controlled trial in The Lancet. The study gave children aged 3 and 8-9 either a mixture of artificial food colors plus sodium benzoate (a common preservative) or a placebo drink, then measured hyperactivity using standardized assessments.

The dye mixture included: Sunset Yellow (Yellow 6), Carmoisine, Tartrazine (Yellow 5), Ponceau 4R, Quinoline Yellow, and Allura Red (Red 40). The study found statistically significant increases in hyperactivity in both age groups after consuming the mixture — not just in children diagnosed with ADHD, but in the general population of children tested.

The UK Food Standards Agency reviewed the findings and recommended that manufacturers voluntarily remove the "Southampton Six" dyes from their products. Most UK manufacturers complied. When the European Commission acted, it required mandatory warning labels on products containing any of these dyes across all EU member states — a requirement still in force today.

Study limitation

The McCann study tested a mixture of dyes and sodium benzoate together, not individual dyes in isolation. It is not possible to determine from the study alone which component(s) drove the observed effect, or whether the effect requires the combination. Subsequent studies have attempted to isolate individual dyes with mixed results.

The FDA's advisory committee review

Following the McCann study, the FDA convened an advisory committee in March 2011 to review the evidence on food dyes and children's behavior. The committee's conclusion was more cautious than the EU's regulatory response: the FDA found that the evidence did not establish a causal link sufficient to require warning labels or bans, but acknowledged that a subset of children — particularly those with ADHD — may be sensitive to synthetic dyes.

The FDA committee vote was not unanimous. Several members wanted stronger action, citing the precautionary principle. The majority position was that the evidence showed an association in sensitive children but was not strong enough to conclude that dyes cause hyperactivity in the general pediatric population. No regulatory action resulted from the 2011 review.

In 2025, the FDA changed course significantly. Citing accumulating evidence and an administration push to review synthetic additives, the FDA announced it would phase out six petroleum-derived synthetic dyes from the food supply by the end of 2027 and would work with manufacturers to transition to natural alternatives. Red Dye 3 had already been banned separately in January 2025 due to a different concern — thyroid tumors in high-dose rat studies.

California's Food Safety Act and warning labels

California passed the California Food Safety Act (AB 418) in 2023, which originally included provisions targeting certain food dyes. A subsequent law, the School Food Safety Act (AB 2316, signed 2024), specifically prohibited the sale of food containing six synthetic dyes — Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 — in California public school cafeterias starting December 31, 2027.

Earlier California legislation required warning labels on products containing these dyes intended for children. The trajectory in California mirrors what the EU did over a decade earlier: warning labels first, then restrictions in children's settings.

DyeUS FDA StatusEU Status

Red 40 (Allura Red)

E129

Approved — phase-out by end of 2027 announcedPermitted; mandatory hyperactivity warning label

Yellow 5 (Tartrazine)

E102

Approved — phase-out by end of 2027 announcedPermitted; mandatory hyperactivity warning label

Yellow 6 (Sunset Yellow)

E110

Approved — phase-out by end of 2027 announcedPermitted; mandatory hyperactivity warning label

Blue 1 (Brilliant Blue)

E133

Approved — phase-out by end of 2027 announcedPermitted; mandatory hyperactivity warning label

Red 3 (Erythrosine)

E127

Banned in food January 2025Banned in food since 1994 (EU)

Green 3 (Fast Green FCF)

E143

ApprovedNot permitted

The science: what the evidence actually supports

The current state of evidence, as summarized by a 2012 meta-analysis in the Journal of the American Academy of Child and Adolescent Psychiatry (Nigg et al.), found a small but statistically significant relationship between artificial food color consumption and increased ADHD symptoms in children. The effect size was small — comparable to lead exposure effects at low doses — but consistent across studies.

Key caveats: the research does not establish that dyes cause ADHD. Children with existing ADHD or behavioral sensitivities appear more affected than neurotypical children. The effect is behavioral (hyperactivity, inattention) rather than structural — no studies show dyes alter brain development or cause lasting changes in neurological function. Most studied children showed no measurable effect.

Separately, several synthetic dyes have raised concerns unrelated to behavior. Yellow 5 (Tartrazine) is associated with allergic reactions, particularly in aspirin-sensitive individuals. Red 40 is under EFSA genotoxicity review as of 2024. These are distinct safety questions from the hyperactivity research.

Where are these dyes found?

Synthetic food dyes are concentrated in products marketed heavily to children. The highest-exposure categories include:

  • Candy and gummiesSkittles, gummy bears, M&Ms, Starbursts
  • Breakfast cerealsFroot Loops, Cap'n Crunch, Lucky Charms
  • Sports and fruit drinksGatorade, Kool-Aid, Capri Sun (some varieties)
  • Snack foodsDoritos, Cheetos, flavored crackers
  • Frosted baked goodsPop-Tarts, cupcakes with colored frosting, decorated cookies
  • Frozen treatsPopsicles, sherbet, flavored ice cream

Reading labels for dyes

Synthetic dyes must be listed by their full name in the ingredient list — "Red 40," "Yellow 5," "Blue 1," etc. A product labeled "made with natural colors" or "no artificial colors" will not contain them. The front-of-pack color alone is not a reliable indicator — beet juice, turmeric, and spirulina can produce vivid colors without synthetic dyes.

Sources

  • McCann D, et al. '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, 2007.
  • FDA Food Advisory Committee. 'Certified Color Additives in Food and Possible Association with Attention Deficit Hyperactivity Disorder in Children.' Meeting summary, March 2011.
  • Nigg JT, et al. '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 and Adolescent Psychiatry, 2012.
  • European Commission Regulation (EC) No 1333/2008 — mandatory warning label requirement for certain food colors.
  • California AB 2316 — School Food Safety Act, signed 2024.
  • FDA. 'FDA to Phase Out Petroleum-Based Synthetic Dyes in US Food Supply.' Press release, 2025.