Red 40 is a synthetic petroleum-derived azo dye used to add red, orange, or berry coloring to foods, beverages, and oral care products. It is the most widely used artificial food dye in the United States, found in candy, cereals, snacks, fruit-flavored drinks, and children's toothpaste.
Red 40 is flagged SEVERE because the American Academy of Pediatrics identified it as a food additive with evidence of behavioral effects in children, including hyperactivity and inattention. The European Union requires a mandatory warning label on products containing Red 40 stating 'may have an adverse effect on activity and attention in children.' Multiple countries have banned or restricted its use.
Children ages 2-12, particularly those with ADHD or family history of attention disorders. Effects are dose-dependent and more pronounced when multiple artificial dyes are consumed together.
| Country | Status |
|---|---|
| United States | Permitted. FDA approved with no restrictions on use in children's products. No warning label required. |
| European Union | Permitted with mandatory warning: 'may have an adverse effect on activity and attention in children' (EU Regulation 1333/2008). Many manufacturers voluntarily reformulated to avoid the label. |
| Canada | Permitted. No warning label required. |
| Australia | Permitted as E129. No mandatory warning. |