Beta-Carotenes

Identifiers
CAS No. 7235-40-7
CI Food Orange 5

Beta-Carotene, synthetic

  • INS No. 160a(i)
  • Beta-Carotene
  • E 160a(i)
  • EINECS No. 230-636-6
  • CI No. 40800

Carotenes (vegetable)

  • INS No. 160a(ii)
  • Carrot Oil
  • Plant Carotenes
  • E160a(ii)
  • EINECS No. 230-636-6
  • CI No 75130
  • Natural Beta-carotene
  • carotenes-natural
  • mixed carotenes

Beta-Carotene from Blakeslea trispora

  • INS No. 160a(iii)
  • Beta-Carotene
  • E160a(iii)
  • EINECS No. 230-636-6
  • CI No. 40800

Carotenes (Algae)

  • INS No. 160a(iv)
  • Beta-Carotene
  • Algal Carotenes
  • E160a(iv)
  • CI No. 75130
  • Natural Beta-carotene
  • carotenes-natural

Physical Description
Beta-Carotene, an isomer of the naturally occurring carotenoid Carotene, is the pigment largely responsible for the color of various products obtained from nature. β -carotene may be obtained from natural sources, such as various edible vegetable sources or by fermentation from Blakeslea trispora, or produced synthetically from acetone. Both the synthetically produced and the natural sources of β -carotene can be used as color additives. All types of Carotenes display Pro-Vitamin A activity. Carotenes are generally available in shades of yellow to yellow-orange  but can also be found in orange or red shades. Carotenes offer excellent light, heat and pH stability.

Common Uses
β -carotene is used in margarine, shortening, butter, cheese, baked goods, confections, ice cream, eggnog, macaroni products, soups, juices, and beverages. Carotenes may also be used in dairy products, bakery products, meat, seafood, snack food, fruit preparations, and convenience foods.

Specifications
US FDA

JECFA

EU defined in Commission Regulation (EU) No 23/2012

Codex GSFA Provisions
Carotenes are added to foods and beverages at concentrations up to a maximum permitted level (MPL) as established by the Codex Alimentarius Commission and published in the General Standard of Food Additives (GSFA) (CODEX STAN 192-1995, 2015).

Regulatory Approvals/Consumption Limits
USA: Both Beta-Carotene (21 CFR 73.95) and Carrot Oil (21 CFR 73.300) are allowed at GMP for use in foods generally

EU: No ADI established (EFSA, 2012)

JECFA: 0-5 mg/kg bw, Group ADI for beta-carotene (synthetic) and beta-carotene from Blakeslea trispora (57th Report, 2001). ADI of acceptable established for carotenes (vegetable) provided the level of use does not exceed the level normally found in vegetables and no ADI was allocated for carotenes (algae) (41st Report, 1993).

Safety Assessment
β -carotene is not genotoxic by the weight of evidence analysis  and it is reported to have antimutagenic properties. Mammals differ in the intestinal metabolism of β -carotene. Man absorbs unchanged carotenoids to some extent, while rats do not absorb unchanged carotene beyond the intestinal mucosa. The major metabolite of β -carotene is vitamin A. In man absorbed β -carotene is largely converted to vitamin A and then esterified and transported in the lymph in the same manner as dietary retinol. Approximately 50-70% of the β -carotene orally administered to rats is absorbed. The extremely low acute oral toxicity of β -carotene is reflected by the LD50 value in dogs which exceeds 8 g/kg. Hypercarotenemia and nausea were the only effects observed in humans consuming approximately 0.7-2.8 mg/kg bw/day of pure β -carotene for several months. Hypercarotenemia, the accumulation of β -carotene in the body, is generally considered harmless because it produces no symptoms other than coloration of the skin. It is not associated with vitamin A accumulation (hypervitaminosis A), which may lead to toxicity. No adverse effects were seen in rats or mice fed up to 1 g/kg bw/day or dogs fed up to 250 mg/kg bw/day of beta-carotene for up to 2 years. It has been reported that β -carotene has anticarcinogenic properties. No reproductive toxicity or teratogenic effects occurred when four successive generations of rats were fed 50-100 mg/kg bw/day of β -carotene. A slight reduction in body weight was seen in the offspring of rats fed 1 g/kg bw/day of β -carotene on days 7-16 of pregnancy. No embryotoxic or teratogenic effects were observed in the offspring of rabbits given up to 400 mg/kg bw/day via stomach tube on days 7-19 of pregnancy.

Safety Reviews
JECFA (2001) Evaluation of certain food additives and contaminants. 57th report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series 909. Available online.

JECFA (1993) Evaluation of certain food additives and contaminants. 41st report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series 837. Available online.

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the reevaluation of Mixed Carotenes (E 160a (i)) and beta-Carotene (E 160a (ii)) as a food additive. EFSA Journal 2012;10(3):2593. [67 pp.] doi:10.2903/j.efsa.2012.2593. Available online.

Full safety monograph, including references, available to IACM members or upon request.