Beta-Apo-8’-Carotenal

Synonyms/Identifiers
Beta-apo-8’-carotenal (C30)
INS No. 160e
CAS No. 1107-26-2
E No. E 160e
CI Food Orange 6
CI No. 40820betaapo8carotenal
Physical Description
β-Apo-8′-carotenal is an aldehydic carotenoid that is widely distributed in nature. It can be isolated from spinach, oranges, grass, tangerines, and marigolds. Synthetic production yields the crystalline all-trans stereoisomer which is a purplish-black powder that melts (with decomposition) in the range 136-140 °C. It is oxidized in air and sparingly soluble in polar solvents like ethanol.

Common Uses
β-apo-8′-carotenal can be used to color confectionery, bakery products, snack food, juices, fruit drinks, soups, jams, jellies, gelatins, processed cheese, margarine, salad dressings, fats and oils.

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

Codex GSFA Provisions
β-apo-8′-carotenal 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 Approvals/Consumption Limits
USA: The quantity of β-apo-8′-carotenal may not exceed 15 mg/lb of solid or semisolid food or 15 mg/pt of liquid food (21 CFR 73.90).

JECFA:  A group ADI of 0-5 mg/kg bw expressed as the sum of carotenoids including β-carotene, β-apo-8’-carotenal, and the methyl and ethyl esters of β-apo-8’-carotenoic acid was established at the 18th JECFA (1974).

EU: ADI of 0.05 mg/kg bw/day(EFSA, 2012). EFSA has also established MPLs for use of β-apo-8’-carotenal in foods and beverages in Europe (Council Directive 94/36/EC).

Safety Assessment
No relevant genotoxicity data were identified. Ethyl and methyl β-apo-8′-carotenate, free and esterified vitamin A, and vitamin A alcohol were identified as metabolites of β-apo-8′-carotenal. The absorption of β-apo-8′-carotenal from the GI tract is poor, but the accumulation of pigments or metabolites, including vitamin A, has occurred following ingestion by several species of laboratory animals. The low acute oral toxicity of β-apo-8’-carotenal is demonstrated by a mouse LD50 that exceeds 10 g/kg bw. Although pigment deposition was found in the kidney, adrenal and fatty tissue of dogs fed 10 or 100 mg/kg bw/day β-apo-8′-carotenal for 14 weeks, blood analyses, and the microscopic appearance and weights of the organs were normal. Increased vitamin A levels were found in the kidneys. Apart from the pigment deposition in the liver and kidneys, no adverse effects occurred in rats fed up to 500 mg/kg bw/day β-apo-8′-carotenal for 34 weeks. No adverse effects were reported in a summary of multigeneration studies where rats were fed 250 mg/kg bw/day of β-apo-8’-carotenal or 500 mg/kg bw/day of its methyl ester. The fertility of rats fed 500 mg/kg bw/day of β-apo-8’-carotenal or its ethyl ester was also unaffected.

Safety Reviews
JECFA (1974). Toxicological evaluation of some food colors, enzymes, flavor enhancers, thickening agents and certain food additives. FAO Nutr. Mtgs. Ser. No. 54; WHO Tech. Rept. Ser. No. 557. Eighteenth 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 re-evaluation of β-apo-8’-carotenal (E 160e) as a food additive. EFSA Journal 2012;10(3):2499. [46 pp.] doi:10.2903/j.efsa.2012.2499. Available online.

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