Lutein

Synonyms/Identifiers
INS No. 161b (i-ii)
E 161b
EINECS No. 204-840-0
CAS No. 127-40-2
Lutein from Tagetes erecta
Tagetes extract
Mixed carotenoids
Xanthophylls
Bo-Xan

luteinPhysical Description
Lutein is 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.

Common Uses
Common uses include beverages, confectionery, dairy products, and bakery.

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

Codex GSFA Provisions
There are currently no adopted Codex provisions for Lutein from Tagetes erecta or Tagetes extract. There are a number of proposed provisions for Lutein from Tagetes erecta at Step 4 at levels of 500 to 500 mg/kg or at GMP.

Regulatory Approvals/Consumption Limits
JECFA: Group ADI for lutein from Tagetes erecta and synthetic zeaxanthin of 0-2 mg/kg bw day (63rd report, 2004). No ADI allocated for tagetes extract (31st report, 1987)

USA: Tagetes (Aztec marigold) meal and extract may be safely used in chicken feed in accordance with prescribed conditions (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) Lutein has maximal allowed use levels of 50 to 500 mg/kg food for various foodstuffs. Lutein is also allowed in beverages at levels up to 200 mg/l.

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.]. doi:10.2903/j.efsa.2010.1678. 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.

Full safety monograph available to IACM members or upon request.