Is Red 40 banned in Europe?

No. Red 40 (E129) is approved in the EU. However, EU law requires a warning label — 'may have an adverse effect on activity and attention in children' — on foods containing it, following the 2007 Southampton study (McCann et al., The Lancet 2007;370:1560–1567). Several EU member states have voluntarily reformulated to avoid it.

How much Red 40 is a person allowed to consume?

The EFSA and JECFA ADI is 7 mg/kg body weight per day. The FDA ADI is the same. A single serving of a brightly coloured breakfast cereal or fruit-flavoured drink typically contains 5–20 mg of Red 40, so most adults consume less than a tenth of the ADI on a typical day; heavy consumers, especially children eating multiple coloured products daily, can approach it.

Is Red 40 in prescription medications?

Frequently. Red 40 is used to colour pills, capsules, and syrups. FDA rules require the specific colour to be listed on the drug facts panel and the prescribing information, but the colour itself does not need a separate warning.

Was Red 3 banned in the US?

Yes, in January 2025 the FDA revoked its authorisation for use in food and ingested drugs. Reformulation deadlines run to January 2027 for food and January 2028 for drugs. Red 3 (erythrosine) is a different molecule from Red 40 — the two dyes share only the colour, not the chemistry — and the Red 3 revocation does not carry over to Red 40.

Red 40 (Allura Red AC, E129)

Red 40, also known as Allura Red AC, FD&C Red No. 40, or E129, is a synthetic azo dye derived from petroleum and approved by the FDA and EFSA as a colour additive for foods, beverages, and medications. It is the most-used food dye in the United States by volume.

What is Red 40?

Red 40, also known as Allura Red AC, FD&C Red No. 40, or E129, is a synthetic azo dye — a class of colours defined by the presence of one or more azo groups (–N=N–) bridging aromatic rings. It is manufactured by coupling diazotised 5-amino-4-methoxy-2-toluenesulfonic acid with 6-hydroxy-2-naphthalenesulfonic acid, producing a bright red water-soluble powder.

It was first approved by the FDA in 1971 as a certifiable colour under 21 CFR 74.340, replacing FD&C Red No. 4 which had been decertified. It is approved in the EU under Regulation (EC) No 1333/2008 as E129 and by JECFA at an ADI of 7 mg/kg body weight per day. It is the most widely used food dye in the US by volume.

What foods and drinks contain Red 40?

Fruit-flavoured drinks — Kool-Aid, Gatorade Fruit Punch, Powerade.
Sugar-sweetened breakfast cereals — Fruity Pebbles, Froot Loops, Trix.
Candy — Skittles, Starburst, M&Ms, jelly beans.
Sweetened yoghurts and puddings — strawberry and mixed-berry varieties.
Ice creams, popsicles, and frozen desserts.
Toaster pastries and snack cakes — Pop-Tarts strawberry, Twinkies red velvet.
Baked goods with red icings or fillings.
Prescription medications — some cough syrups, capsules, and paediatric formulations.

What does the research say about Red 40 and behaviour?

The best-known behavioural study is McCann et al. (2007) in The Lancet — the "Southampton study" — which tested two mixtures of six synthetic colours plus sodium benzoate against a placebo in 297 children aged 3 and 8/9. Both mixtures produced small but statistically significant increases in a composite measure of hyperactivity.

The Southampton study triggered the EU-wide warning-label requirement in 2010: any food containing one of the six colours (Sunset Yellow FCF, Quinoline Yellow, Carmoisine, Allura Red — Red 40 — Tartrazine, or Ponceau 4R) must be labelled "may have an adverse effect on activity and attention in children." The FDA reviewed the same evidence in 2011 and concluded that a causal link had not been demonstrated, but a 2021 California Office of Environmental Health Hazard Assessment (OEHHA) report reached the opposite conclusion — that synthetic food dyes can cause or exacerbate neurobehavioural problems in some children.

A 2012 meta-analysis by Nigg et al. (Journal of the American Academy of Child and Adolescent Psychiatry) pooled 24 studies and reported a small but statistically significant effect size (0.18 standard deviations) of artificial food colouring restriction on ADHD symptoms in children. The subgroup of children with confirmed ADHD showed a larger effect (0.42). The clinical significance for the general paediatric population remains debated.

Regulatory divergence — US vs EU vs California

Jurisdiction	Red 40 status	Labelling requirement
US federal (FDA)	Certified; permitted in food, drugs, cosmetics	Ingredient list only; no behavioural warning
California (2028)	Banned from foods served in public schools starting 2028	Schools only; state-wide food ban not enacted
EU (EFSA)	Approved as E129	Mandatory 'may affect activity and attention in children' warning
Norway, Austria (pre-2010)	Banned individually until harmonisation forced approval	—

Multinationals routinely reformulate their EU versions to remove Red 40 (and often the other five Southampton colours) using natural alternatives — beet juice concentrate, paprika oleoresin, anthocyanins, carmine — to avoid the mandatory warning. The same brands sold in the US retain the synthetic dye because no warning applies. This is the single clearest example of the regulatory divergence covered in the additives hub.

How does NakedCalorie flag Red 40?

Red 40 is a Tier 2 evidence-linked additive in the encyclopedia — surfaced individually on every scan with the McCann 2007, Nigg 2012, and California OEHHA 2021 references. Presence of Red 40 triggers NOVA Group 4 classification under Monteiro 2019 (any cosmetic colour is a Group 4 marker).

Products marketed to children receive an additional flag when Red 40 is present, reflecting the behavioural-effect evidence and the EU warning label. For related additives see aspartame and sodium benzoate — the same Southampton study that flagged Red 40 also tested sodium benzoate in the mixture. For the class-level discussion see the colours section on the additives hub.