beta-Carotenes

Identifiers

INS No. 160a(i); beta-Carotene (synthetic)
INS No. 160a(ii); Carotenes (vegetable)
INS No. 160a(iii); E160a(iii); beta-Carotene from Blakeslea trispora
INS No. 160(iv); beta-carotene-rich extract from Dunaliella salina
E160a(i); beta-carotene
E160a(ii); plant carotenes
E160a(iv); algal carotenes
CI Food Orange 5
Carotenes

Physical Description

β- Carotene is prepared synthetically or obtained from natural sources. Synthetic β- Carotene occurs as red crystals or as crystalline powder. It consists predominantly of all-trans-β-carotene, but may also contain minor amounts of cis-isomers and other carotenoids such as all-trans-retinal, beta-apo-12′-carotenal, and beta-apo-10′-carotenal.

Carotenes (vegetable) are obtained by solvent extraction of carrots (Daucus carota), oil of palm fruit (Elaeis guinensis), sweet potato (Ipomoea batatas) and other edible plants with subsequent purification. The main coloring principles are alpha-and β-Carotenes of which β-Carotene account for the major part. Carrot oil is the liquid or solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots.

β-Carotene from Blakeslea trispora occurs as red, brownish-red, or purple-violet crystals or as crystalline powder, with  the color varying depending on the solvents used and the crystallization conditions. β-Carotene from Blakeslea trispora consists predominantly of all-trans-β-carotene, but may also contain minor amounts of cis-isomers and other carotenoids, of which γ-carotene is the most characteristic type.

β-Carotene-Rich Extract from Dunaliella salina is obtained by extraction from strains of the algae Dunaliella salina using the essential oil d-limonene. The extract is then prepared as a suspension in vegetable oil after removal of the essential oil. The main coloring principles are trans- and cis–isomers of ß-carotene together with minor amounts of other carotenes including α-carotene, lutein, zeaxanthin and cryptoxanthin.

Common Uses

β –carotene can be 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

JECFA

US FDA

Commission Regulation (EU) No 23/2012

Codex GSFA Provisions

Carotenoids, including beta-Carotenes, Blakeslea trispora (INS No. 160a(iii) and beta-Carotenes, synthetic (INS No. 160a(i)) 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 adopted in the General Standard of Food Additives. 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 MPL as adopted in the General Standard of Food Additives. Many applications for the use of beta-Carotene-rich extract from Dunaliella Salina (INS No. 160a(iv)) as a color additive in foods and beverages have been proposed and are pending adoption.

Regulatory Approvals

JECFA: ADI withdrawn for beta-carotene (synthetic) and beta-carotene from Blakeslea trispora (87th meeting, 2019). The Committee was unable to establish a group ADI for synthetic β-carotene, β-carotene derived from B. trispora, β-carotene-rich extract from D. salina, and β-apo-8′-carotenoic acid methyl and ethyl esters because a group ADI is applicable to the general population, which includes heavy smokers. The Committee noted that it is very unlikely that it will ever be possible to establish a group ADI because further data from the population of heavy smokers cannot be gathered ethically. ADI of not specified established for beta-carotene-rich extract from D. salina (84th meeting, 2017). ADI of not specified established for carotenes (vegetable) provided the level of use does not exceed the level normally found in vegetables (41st Report, 1993).

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 for mixed carotenes (E 160a(i)) and beta-carotene (E 160a(ii)) (EFSA, 2012). EFSA has authorized carotenes (E 160a) for use in specific food and beverage categories at quantum satis via Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives

Safety Reviews

Safety Evaluation of certain food additives (Eighty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives) WHO Food Additive Series, No. 78, 2020. Available online

Evaluation of certain food additives (Eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives) WHO Food Additives Series, No. 75 . Available online

Evaluation of certain food additives and contaminants (41st report of the Joint FAO/WHO Expert Committee on Food Additives) WHO Technical Report Series No. 837, 1993. 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