Canthaxanthin

Synonyms/Identifiers
canthaxanthinINS No. 161g
E161g
EINECS No. 208-187-2
CAS No. 514-78-3
CI Food Orange 8
CI No. 40850

Physical Description
Canthaxanthin was first extracted from an edible mushroom, Cantharellus cinnabarinus, in 1950. It has since been identified in sea trout, algae, daphnia, salmon, brine shrimp, and several species of flamingo. In addition to these natural sources, canthaxanthin can be synthetically produced from acetone. Canthaxanthin crystals are insoluble in ethanol and poorly soluble in other solvents. Canthaxanthin is chemically stable at pH 2-8, and sensitive to light and oxygen. It is commercially available as a dry powder and a water-dispersible, dry beadlet composed of 10% colorant, gelatin, vegetable oil, sugar, starch, antioxidants, and preservatives.

Common Uses
Canthaxanthin is a reddish-orange color additive used in tomato products, fruit drinks, sausage products and baked goods.

Specifications
US FDA
JECFA
EU defined in Commission Regulation (EU) No 23/2012

Codex Provisions
Canthaxanthin is 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, 2016).

Regulatory Approval/Consumption Limits
USA: The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions: (i) the quantity of canthaxanthin may not exceed 30 mg per pound of solid or semisolid foods or per pint liquid. (ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (21 CFR 73.75)

EU: 0-0.3 mg/kg ADI (EFSA, 2010), The use of canthaxanthin as food additive in the EU is restricted to the coloring of saucisse de Strasbourg, at a level of 15 mg/kg (Directive 94/36/EC)

JECFA: 0-0.03 mg/kg ADI (44th report, 1995)

Safety Assessment
Canthaxanthin is not genotoxic by a weight of evidence analysis. Canthaxanthin is  poorly absorbed from the gastrointestinal tract of animals. Once absorbed canthaxanthin is slowly eliminated from the plasma. Most canthaxanthin is transferred to fat tissue where remobilization is slow, even under conditions of rapid fat utilization. Although poorly absorbed, canthaxanthin, like other carotenoids may be cleaved by cellular dioxygenase to form two identical fragments of 4-oxoretinal. The low acute toxicity of canthaxanthin is demonstrated by an oral LD50=10,000 mg/kg  in mice.

Canthaxanthin was fed to 4 week old CD-1 mice (60/sex/group) at dietary levels of 0 (control), 0 (control), 250, 500 or 1000 mg/kg bw/day for 90 weeks (males) or 98 weeks (females). Apart from a generalized orange discoloration of fur/skin, subcutis, adipose tissue and gastrointestinal tract, no treatment-related effects were observed. No adverse effects were observed when dogs were given canthaxanthin at oral doses of 0, 50, 100 or 250 mg/kg bw/day for 52 weeks.

In a three-generation reproduction study, rats received canthaxanthin via micro-encapsulated water soluble beadlets at dietary levels of 0, 0 (control), 250, 500 and 1000 mg/kg bw/day. There were no treatment-related effects on mating, gestation, parturition, lactation or the ability of the dams to successfully rear their offspring. FU-Albino rats (40/group) were given canthaxanthin at dietary doses of 0, 250,  500 or 1000 mg/kg bw/day on days 7 to 16 of pregnancy. No treatment-related effects were observed on the dams and there was no indication of embryotoxic or teratogenic effects at any dose level.

Safety Reviews
JECFA (1995). Evaluation of certain food additives and contaminants. WHO Technical Report Series. No. 859. Forty-forth meeting of the Joint FAO/WHO Expert Committee on Food Additives. Available online.

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the reevaluation of canthaxanthin (E 161 g) as a food additive. EFSA Journal 2010; 8(10):1852 [42 pp.]. Available online.

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