HomeIngredients › Red 40 / Allura Red (E129)

Is Red 40 (Allura Red) safe?

By LabelCop · Last updated 13 July 2026 · Sources: EFSA, FDA, FSSAI, WHO/JECFA

The short answer: it's legal almost everywhere — but the EU makes it carry a child-hyperactivity warning, and the US is asking industry to drop it.

What is Red 40?

Which foods contain it?

What the regulators actually say

RegulatorStatusReasoning
EFSA / European UnionPermitted, with mandatory warning labelEFSA's 2009 re-evaluation set an acceptable daily intake of 7 mg/kg body weight and concluded the evidence did not substantiate a causal link to hyperactivity. But after the 2007 Southampton study, the EU required foods containing E129 to carry the warning "may have an adverse effect on activity and attention in children" — in force since 2010. Denmark, Belgium, France and Switzerland restricted or banned it before EU-wide harmonisation.
FDA (United States)Permitted, voluntary phase-out under wayRed 40 remains a lawfully authorised colour additive. In April 2025 the FDA and HHS announced a plan to phase petroleum-based synthetic dyes, including Red 40, out of the US food supply — a voluntary industry commitment targeting roughly end-2026 to 2027, with regulation threatened if compliance lags. The FDA has been approving natural replacements (beetroot red, gardenia blue) to speed the switch. Several states, including California and West Virginia, have passed their own restrictions.
FSSAI (India)Permitted in specified foodsAllura Red (INS 129) is one of the eight synthetic colours permitted in India, in specified categories within prescribed limits — commonly 100 mg/kg. No warning label is required.
WHO / JECFANo safety concern at typical intakesJECFA's 2016 re-evaluation confirmed an acceptable daily intake of 0–7 mg/kg body weight and concluded dietary exposure does not present a health concern for the general population.
UK, Canada, AustraliaPermittedPermitted within limits. The UK retained the EU-style child-activity warning label after Brexit; Canada and Australia require no warning.

Why do regulators disagree?

How LabelCop scores it

Frequently asked questions

Is Red 40 banned in the United States?

No. It remains lawfully authorised. The FDA announced a voluntary industry phase-out of synthetic dyes including Red 40 in April 2025, targeting roughly end-2026 to 2027, and some states have passed their own restrictions — but there is no federal ban.

Does Red 40 cause hyperactivity in children?

Regulators disagree on the strength of the evidence. The 2007 Southampton study linked colour mixes including Allura Red to increased hyperactivity; the EU responded with a mandatory warning label. EFSA and the FDA concluded no causal link is established for the general population, though effects in some sensitive children cannot be excluded.

Is Red 40 banned in Europe?

No — it is permitted EU-wide, but foods containing it must carry the warning "may have an adverse effect on activity and attention in children". Denmark, Belgium, France and Switzerland restricted it before EU rules were harmonised.

Is Red 40 permitted in India?

Yes. FSSAI permits Allura Red (INS 129) as one of eight synthetic colours, in specified foods within prescribed limits — commonly 100 mg/kg. Look for INS 129 on the ingredients list.

Is Red 40 the same as Red 3?

No. Red 3 (erythrosine, E127) was banned in US foods by the FDA in January 2025 over cancer findings in rats. Red 40's debate is about behaviour in children, not cancer — and it remains authorised in the US and most countries.

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Sources

EFSA (2009): re-evaluation of six food colours including Allura Red (E129) · EFSA (2015): refined exposure assessment for Allura Red AC (E129) · Regulation (EC) 1333/2008, Annex V — EU child activity-and-attention warning label · FDA: colour additives — questions and answers · FDA/HHS (April 2025): plan to phase out petroleum-based synthetic dyes · WHO/JECFA additives database — Allura Red AC (2016 evaluation) · FSSAI: Food Safety and Standards regulations — permitted additives

Related ingredients: Titanium dioxide (E171) · Aspartame (E951) · MSG (E621) · Sodium benzoate (E211) — the preservative tested alongside the colours in the Southampton study

This article explains regulatory status and published scientific assessments in plain English. It is not medical advice.