Carotenes

 

Identifiers

INS No. 160a (i-iv)
Carotenes, beta-, synthetic
Carotenes, beta-, vegetable
Carotenes, beta-, Blakeslea trispora
Beta-Carotene-rich extract from Dunaliella salina

E160a(i-iv)
beta-carotene
Plant carotenes
Beta-carotene from Blakeslea trispora
Algal carotenes

Carrot oil
CI Food Orange 5
EINECS 230-636-6

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

Carotenes are natural orange food colors used in a wide range of food and beverages including cider, malt beverages, water-based flavored drinks, margarines, cheeses, cake fillings, custards, yogurts, processed nuts, precooked pastas and noodles.

Specifications

US FDA

JECFA

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

Codex GSFA Provisions

Carotenoids, including beta-apo-8′-Carotenal (INS No. 160e), beta-Carotenes, Blakeslea trispora (INS No. 160a(iii) and beta-Carotenes, synthetic (INS No. 160a(i)), and beta-apo-8′-Carotenoic acid, ethyl ester (INS No. 160f) are added to foods and beverages at concentrations in more than 70 food categories up to a maximum permitted level (MPL) as established by the Codex Alimentarius Commission and published in the General Standard of Food Additives (GSFA).

Additionally, vegetable beta-Carotenes (INS No. 160a(ii)) are added to foods and beverages at concentrations in more than 80 food categories up to a maximum permitted level (MPL) as established by the Codex Alimentarius Commission and published in the General Standard of Food Additives (GSFA). Many applications for the use of Beta-Carotene-rich extract from Dunaliella Salina (INS No. 160(aiv)) as a color additive in foods and beverages have been proposed and are pending authorization, following completion of the review and comments process.

Regulatory Approvals

USA: β -carotene is exempt from certification and may be safely used for coloring foods generally (21 CFR 73.95), for coloring drugs generally, including those for eye area (21 CFR 73.1095), and for coloring cosmetics generally, including those for eye area (21 CFR 73.2095) in amounts consistent with GMP. Also, carrot oil is exempt from certification and may be safely used for coloring foods generally in amounts consistent with GMP (21 CFR 73.300)

EU: No ADI established (EFSA, 2012). EFSA has authorized carotenes for use in specific food and beverage categories at quantum satis

JECFA: ADI withdrawn for beta-carotene (synthetic) and beta-carotene from Blakeslea trispora (2019). ADI of not specified established for beta-carotene-rich extract from D. salina (84th meeting, 2017). ADI of acceptable established for carotenes (vegetable) provided the level of use does not exceed the level normally found in vegetables (41st Report, 1993).

Safety Reviews

Evaluation of certain food additives (Eighty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives) WHO Technical Report Series, No. 1020, 2019. Available online.

Evaluation of certain food additives: prepared by the Eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Geneva: World Health Organization and Food and Agriculture Organization of the United Nations; 2019 (WHO Food Additives Series, No. 75). Available online

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