Beta-carotene

What this is

This page is for Beta-carotene. Its food-use assessment is Limited. The accepted joint review below explains the distinct evidence for both components. These two colors need separate interpretation. In 2026, JECFA estimated that high-consuming EU toddlers could receive beta-apo-8′-carotenal above its acceptable daily intake, a protective benchmark for long-term exposure. This was a dietary model using typical use levels, not evidence that children had suffered injury. For beta-carotene, the same review found higher upper exposure estimates but could not characterize their toxicological meaning because no acceptable daily intake has been established. Stronger human harm evidence concerns beta-carotene supplements in smoking-related risk groups: trials found increased lung cancer with sustained supplemental doses, and follow-up evidence also raises concern for former smokers. These findings should not be equated with ordinary coloring use or carotenoids in vegetables. A 2026 French cohort linked additive beta-carotene intake with diabetes and cancer in separate analyses of shared participants; this is not independent replication or proof of causation, and randomized supplement studies found no overall diabetes effect. Differences in dose, food context and study population matter. The Moderate concern here is driven by the apocarotenal exposure finding, while beta-carotene food-use evidence remains uncertain. Current US and Canadian rules permit specified uses, and JECFA’s recommendation to review uses is advisory.

Safety Review

The health areas reviewed when evaluating an ingredient. This does not mean the ingredient is proven to cause harm.

Component food-use concern: Limited. The Moderate proposal reflects a meaningful modeled exposure concern for beta-apo-8′-carotenal, whose acceptable daily intake incorporates a safety margin below doses associated with liver and kidney effects in rats, without implying injury at the estimated human intake. Beta-carotene is different: supplement trials identify lung-cancer risk in smoking-related groups, while food-use exposure has no established intake benchmark and recent diabetes and cancer associations from one cohort remain uncertain alongside null randomized supplement diabetes findings. EFSA previously found no indication of harm from background dietary beta-carotene, including food colors, but that assessment predates the newer exposure estimates and cohort analyses. Neither the supplement findings nor an intake-model exceedance establishes a disease risk from one colored food serving.