INS No. 161b (i-iii)
EINECS No. 204-840-0
CAS No. 127-40-2
Lutein from Tagetes erecta
Lutein esters from Tagetes erecta
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.
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.
US FDA (for use in chicken feed)
EU defined in Commission Regulation (EU) No 23/2012
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).
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).
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