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Ingredientartificial dye

Red 40 lake

On our research list
Studies on file
1
Official rulings
0
Rules by country
3

What the research says

Peer-reviewed literature and regulator findings
ReviewIndependent funding

Regulator action: Banned from California public school food (AB 2316, eff. 12/31/2027); FDA requested voluntary industry phase-out by end of 2026; banned in West Virginia schools (eff. 8/2025)

Regulatory status is the clearest fact here. California's School Food Safety Act (signed September 2024) bans this dye from food served in public schools statewide, effective December 31, 2027.

The rest of this record

In April 2025 FDA announced a plan to phase this dye out of the US food supply by end of 2026 — but this is a voluntary request to manufacturers, not a ban. West Virginia enacted a broader statewide ban in March 2025; its school provision took effect August 2025, while the full statewide provision was temporarily blocked by a federal court after an industry lawsuit. On the underlying science: a 2021 systematic review by California's OEHHA, covering 27 human clinical trials plus animal and in vitro data, concluded synthetic food dyes are associated with adverse neurobehavioral effects such as inattentiveness, hyperactivity and restlessness in sensitive children, including some children without pre-existing behavioral diagnoses. FDA's position differs: it states that the totality of evidence shows most children have no adverse effects, while acknowledging some children may be sensitive. The careful reading supported by both sides is that these dyes do not cause ADHD, but may worsen hyperactivity and attention in a subset of susceptible children. Dyes serve a purely cosmetic function, so avoiding them carries no nutritional cost.

Note on this specific form

a "lake" is the aluminium-bound, water-insoluble form of the same dye, used where the dye must not bleed (coatings, fats, tablets). It is the same colour additive chemically and is covered by the same regulatory actions described above.

Read the full research record — every paragraph in full, with each citation, who funded it, what the authors declared, and the date we read the source.

Official rulings

Published decisions by named health and safety agencies
We hold no authority classification for this ingredient. What we check, and what we do not

Global regulation comparison

Regulator publications
United States (federal)
Permitted, no limit set
Permitted as a certified colour additive with no consumer warning required. In April 2025 FDA requested a voluntary industry phase-out by end of 2026 — a request, not a ban. FDA's stated position is that most children experience no adverse effects, while acknowledging some may be sensitive.
United States (California)
Restricted
Banned from food served in public schools statewide under the California School Food Safety Act (AB 2316, signed September 2024), effective 31 December 2027. Still permitted in retail food.
European Union
Permitted with a required warning
Mandatory label: "may have an adverse effect on activity and attention in children"
One of the six "Southampton colours" subject to a mandatory consumer warning under Article 24 of Regulation 1333/2008, in force since 20 July 2010. Notably, EFSA itself concluded the data did not substantiate a causal link between the individual colours and behavioural effects — the warning reflects a precautionary approach rather than a finding of proven harm. Retained in UK law after Brexit.