About
E160aii is natural beta-carotene extracted from vegetable sources such as carrots, palm fruit oil, and algae (e.g. Dunaliella salina); it imparts a yellow-to-orange colour and also serves as a provitamin A precursor. It is widely used as a food colourant and nutritional supplement in soft drinks, dairy products, margarine, snacks, and baked goods.
Safety summary
EFSA's 2012 re-evaluation concluded that no formal ADI could be established but that use of vegetable beta-carotene as a food colour is not of safety concern, provided total intake from food additive use plus supplements does not exceed the amount naturally occurring in the diet (5–10 mg/day) and remains below 15 mg/day. Two independent clinical trials found that high-dose supplementation (≥20 mg/day) was associated with increased lung cancer incidence in heavy smokers, though EFSA confirmed this risk does not arise at sub-15 mg/day intake levels. The use of food colours in infant foods is generally prohibited in the EU.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Beta-carotene is permitted as a food colour and nutrient additive under the FSANZ Food Standards Code. It is also recognised as a permitted beta-carotene source in the Codex GSFA (STAN 192-1995), which FSANZ references.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised as a food colour under Regulation (EC) No 1333/2008. EFSA 2012 re-evaluation withdrew the prior ADI of 0–5 mg/kg bw/day; use is safe provided total beta-carotene intake from food additive and supplement use combined remains at or below naturally occurring dietary levels (5–10 mg/day, and not exceeding 15 mg/day). Use of colours in foods for infants and young children is prohibited under Regulation (EC) No 1333/2008 except under specific authorised conditions.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted as a food colour under FSS (Food Products Standards and Food Additives) Regulations, 2011. Also permitted as provitamin A (beta-carotene, JECFA 1987 purity standard) in infant formula and follow-up formula under FSS (Food for Infant Nutrition) Regulations, 2020.source |
| FDA (Food and Drug Administration) (United States) | Approved | Approved as a color additive for human food (21 CFR 73.95) and affirmed as GRAS for use as a nutrient supplement (21 CFR 184.1245). Also listed under 21 CFR 182.5245 / 182.8245 as GRAS nutrient/dietary supplement; in some food products beta-carotene is used for both colouring and nutritional purposes simultaneously. |
Who should approach with care
Research citations
- 1FDA. Beta-carotene — 21 CFR 73.95 (color additive) and 21 CFR 184.1245 (GRAS nutrient supplement). fda.gov
- 2other. GSFA Online Food Additive Details: beta-Carotenes, vegetable (160a(ii)). fao.org
- 3EFSA. Scientific opinion on the safety of the proposed extension of use of synthetic β-carotene [E 160a(ii)] in foods for special medical purposes in young children, 2016. efsa.europa.eu
- 4EFSA. Statement on the safety of β-carotene use in heavy smokers, 2012. efsa.europa.eu
- 5EFSA. Scientific Opinion on the re-evaluation of Mixed Carotenes (E 160a (i)) and beta-Carotene (E 160a (ii)) as a food additive, 2012. efsa.europa.eu