Luteins

Identifiers

INS No. 161b(i); Lutein from Tagetes erecta
INS No. 161b(ii); Tagetes extract
INS No. 161b(iii); Lutein esters from Tagetes erecta
Tagetes (Aztec marigold) extract
E 161b; Lutein

Physical Description

Lutein occurs as a free-flowing, orange-red powder. It is the purified fraction obtained from saponification of the oleoresin of Tagetes erecta L. Lutein from Tagetes erecta L. is a purified extract of xanthophylls obtained from marigold oleoresin. The oleoresin is prepared from hexane extracts of marigold (Tagetes erecta L) flowers, saponified with potassium hydroxide in either methanol or propylene glycol. The resulting crystalline material contains lutein, and minor components including other carotenoids and waxes.

Tagetes extract occurs as a dark yellow to brown liquid. The major coloring principles are lutein and helenien (dipalmitate of lutein) and they are obtained by the hexane extraction of dried petals of Tagetes erecta L., with subsequent solvent removal. Lutein esters from Tagetes erecta is obtained by solvent extraction of dried petals of Tagetes erecta L., further purification and subsequent removal of solvents under vacuum.

Common Uses

Lutein esters from Tagetes erecta and lutein from Tagetes erecta can be used as food colors in a wide range of baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogues, egg products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, soft and hard candy, infant and toddler foods, milk products, processed fruits and fruit juices, soups and soup mixes.

Specifications

JECFA

US FDA

Commission Regulation (EU) No 23/2012

Codex GSFA Provisions

The Codex Alimentarius Commission has adopted lutein from Tagetes erecta (INS 161b(i)) in the General Standard of Food Additives for use in flavored fluid milk drinks with a maximum permitted level (MPL) of 100 mg/kg. Many other applications of lutein from Tagetes erecta as a color additive in foods and beverages have been proposed and are pending adoption. Lutein esters from Tagetes erecta (161b(iii)) is a food additive that is included in Table 3 of the GSFA, and as such may be used in specified foods under the conditions of good manufacturing practices (GMP) as outlined in the Preamble of the GSFA.

Regulatory Approvals

JECFA: Based on the absence of toxicity in a wide range of studies, the Committee at its 86th meeting established a group ADI “not specified” for lutein from Tagetes erecta, lutein esters from Tagetes erecta and zeaxanthin (synthetic). (86th meeting, 2018) No ADI allocated for tagetes extract (31st report, 1987)

USA: Tagetes (Aztec marigold) meal and extract is exempt from certification and may be safely used in chicken feed to enhance the yellow color of chicken skin and eggs at a quantity that in the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids and meets the tolerance limitation for ethoxyquin in animal feed (21 CFR 73.295)

EU: ADI of 1 mg/kg bw/day for lutein derived from Tagetes erecta containing at least 80% carotenoids consisting of lutein and zeaxanthin (79 and 5% respectively). (EFSA, 2010) EFSA has authorized use for Lutein (E 161b) in specific foods and beverages at maximum allowed use levels.

 

Safety Reviews

Joint FAO/WHO Expert Committee on Food Additives (1987) Toxicological evaluation of certain food additives: thirty-first report of the Joint FAO/WHO Expert Committee on Food Additives. (WHO technical report series; 759). Available online

Evaluation of certain food additives: eighty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives. Geneva: World Health Organization and Food and Agriculture Organization of the United Nations; 2019 (WHO technical report series; no. 1014). Available online

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive on request of the European Commission. EFSA Journal 2010; 8(7):1678 [57 pp.]. Available online