Luteins

 

Identifiers

INS No. 161b (i-iii)
E 161b
EINECS No. 204-840-0
CAS No. 127-40-2

Lutein from Tagetes erecta
Tagetes extract
Lutein esters from Tagetes erecta
Mixed carotenoids
Xanthophylls
Aztec marigold

Physical Description

Lutein is a naturally occurring pigment extracted from marigold flowers (tagetes erecta), grown abundantly throughout South America and Asia. The pigment is a carotenoid and belongs to the group called xanthophylls. Lutein is also used in functional foods due to its antioxidant properties. This color has good stability against light, heat and pH, and provides a warm yellow color. Lutein esters from tagetes erecta is a dark yellow-brown solid insoluble in water and soluble in hexane and is obtained by solvent extraction of dried petals of marigold, further purification and subsequent removal of solvents.

Common Uses

Lutein esters from Tagetes erecta and lutein from Tagetes erecta  are used as food coloring agents and nutrient supplements 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 at levels ranging from 2 to 330 mg/kg.

Specifications

US FDA (for use in chicken feed)

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

JECFA

Codex GSFA Provisions

The Codex Alimentarius Commission has finalized authorization of Lutein from Tagetes erecta (INS 161b(i)) use in flavored fluid milk drinks (food category number 1.1.4) with a maximum permitted level (MPL) of 100 mg/kg, as noted in the General Standard of Food Additives (GSFA) Many other applications of lutein from tagetes erecta as a color additive in foods and beverages have been proposed and are pending authorization, following completion of the review and comments process.

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, as well as food conforming to Commodity Standards for Chocolate and Chocolate Products (CS 87-1981) and Bouillons and Consommés (CS 117-1981).

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 in specific foods and beverages at maximum allowed use levels.

Safety Assessment

JECFA evaluated lutein from Tagetes erecta and lutein esters from Tagetes erecta in 2018 and noted that free lutein, and lutein esters are biochemically and toxicologically equivalent. In its evaluation, JECFA indicated that no adverse effects were observed in a broad range of toxicological studies of free lutein, and lutein esters  in laboratory animals and in clinical studies in humans. The estimated dietary exposure from the use of free lutein, and lutein esters as colors or food supplements are in the same order of magnitude as the intakes from foods where these xanthophylls are naturally present. Based on the absence of toxicity in a wide range of studies with NOAELs of approximately 210–400 mg/kg bw per day for lutein, and estimated dietary exposure of up to 2.4 mg/kg bw per day, the Committee established a group ADI “not specified” for lutein from Tagetes erecta, and lutein esters from Tagetes erecta, as well as and zeaxanthin (synthetic).

Safety Reviews

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

Joint FAO/WHO Expert Committee on Food Additives (2004 : Geneva, Switzerland) Evaluation of certain food additives : sixty-third report of the Joint FAO/WHO Expert Committee on Food Additives. (WHO technical report series; 928). Available online

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

Joint FAO/WHO Expert Committee on Food Additives (2014) Evaluation of certain food additives: seventy-ninth report of the Joint FAO/WHO Expert Committee on Food Additives (WHO Technical Report Series; 990). 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