Carotene
Also known as: E160a, carotin, mixed carotenes
Beta-carotene is FDA-listed as a color additive exempt from certification (21 CFR 73.95) and EFSA reaffirmed safety as a food additive. High-dose (≥20 mg/day) supplements increase lung cancer risk in heavy smokers (CARET, ATBC trials), but food and food-color use are not implicated.
What it is
Mixed carotenes (E160a(i)) and synthetic beta-carotene (E160a(ii)); orange-yellow carotenoid pigments and provitamin A precursors.
Natural / nature-identical food coloring; vitamin A fortification.
Why it's flagged
- increased lung cancer risk for heavy smokers at high supplement doses
What regulators actually say
"The color additive beta-carotene may be safely used for coloring foods generally..."
Regulatory status
United States — FDA
Color additive exempt from certification under 21 CFR 73.95
European Union — EFSA
Authorized food additive (re-evaluated 2012)
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