Beta-carotene / β-apo-8′-carotenal
These carotenoid colors are regulated separately but often appear as a practical label family: beta-carotene is E/INS 160a, while beta-apo-8′-carotenal is E/INS 160e. U.S. FDA regulations permit beta-carotene for coloring foods generally at good-manufacturing-practice levels, and beta-apo-8′-carotenal for foods generally up to 15 mg per pound of solid or semisolid food or 15 mg per pint of liquid food. European Union rules authorize them in listed food categories and set identity and purity specifications; Canada permits carotene and beta-apo-8′-carotenal in specified foods with conditions. The clearest biological caution is not an ordinary-food color signal: high-dose beta-carotene supplements increased lung-cancer risk in heavy smokers or asbestos-exposed groups in intervention trials, so regulators treat supplemental beta-carotene more cautiously than dietary carotenoids. JECFA later withdrew older beta-carotene group ADIs because the rat basis was not appropriate and because an ADI covering heavy smokers could not be ethically resolved, while it set a specific ADI for beta-apo-8′-carotenal of 0–0.3 mg/kg body weight/day. For food-color use, the concern is limited and exposure-related rather than evidence of proven harm at permitted uses.
- Concern
- Limited
- Function
- Coloring Agents
- Updated
- May 25, 2026
What this is
These carotenoid colors are regulated separately but often appear as a practical label family: beta-carotene is E/INS 160a, while beta-apo-8′-carotenal is E/INS 160e. U.S. FDA regulations permit beta-carotene for coloring foods generally at good-manufacturing-practice levels, and beta-apo-8′-carotenal for foods generally up to 15 mg per pound of solid or semisolid food or 15 mg per pint of liquid food. European Union rules authorize them in listed food categories and set identity and purity specifications; Canada permits carotene and beta-apo-8′-carotenal in specified foods with conditions. The clearest biological caution is not an ordinary-food color signal: high-dose beta-carotene supplements increased lung-cancer risk in heavy smokers or asbestos-exposed groups in intervention trials, so regulators treat supplemental beta-carotene more cautiously than dietary carotenoids. JECFA later withdrew older beta-carotene group ADIs because the rat basis was not appropriate and because an ADI covering heavy smokers could not be ethically resolved, while it set a specific ADI for beta-apo-8′-carotenal of 0–0.3 mg/kg body weight/day. For food-color use, the concern is limited and exposure-related rather than evidence of proven harm at permitted uses.
Safety Review
The critical endpoints experts review in safety assessments. This is not a prediction of harm.
The strongest human signal comes from supplement trials in which heavy smokers or asbestos-exposed people received high beta-carotene doses and had more lung cancer, probably reflecting a high-dose, smoke-related interaction rather than the effect of carotenoids in ordinary foods. EFSA has stated that beta-carotene exposure below 15 mg/day from additive and supplement use does not raise concern, but JECFA withdrew beta-carotene ADIs because a general-population ADI would have to cover heavy smokers and the old rat basis was unsuitable. For beta-apo-8′-carotenal, JECFA set an ADI of 0–0.3 mg/kg body weight/day from a 13-week rat study; EFSA’s refined assessment concluded reported uses and use levels were not a safety concern.
No safety review endpoints are listed for this ingredient yet.
Restaurant Usage
3 linked ingredient reports
State Policies
0 linked policies
No current state policy is listed for this ingredient in the policy tracker.
Federal Policies
0 linked policies
No direct federal policy is linked to this ingredient right now.
Sources
0 visible sources
Source population is still pending for this dossier. The page stays visible because the restaurant and policy context is still useful.