LUTEIN ESTERS from TAGETES ERECTA

Comments:

Based on the absence of toxicity in a wide range of studies, the Committee at it's 86th meeting established a group ADI "not specified" for lutein from Tagetes erecta, lutein esters from Tagetes erecta and zeaxanthin (synthetic).

Meeting:

86

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

NOT SPECIFIED

Comments:

The Committee removed the temporary designatione (because the tentative status of the specifications was removed) and established an ADI “not specified” for lutein esters from Tagetes erecta.

Meeting:

82

Specs Code:

R

Report: 

Specification: 

ADI:

NOT SPECIFIED (TEMPORARY)

Comments:

The Committee concluded that there was no need to establish a numerical ADI. This decision was based on a number of factors, including the absence of any observed toxicity of lutein or lutein esters in any of the available toxicological studies in animals; the absence of any adverse effects in humans consuming lutein or lutein esters; the large MOE (>1500) between the NOAEL for lutein equivalents in a new 13-week study and the estimated dietary exposure of 0.32 mg/kg bw per day (from additive and natural sources); a 2-fold increase in the NOAEL for lutein as a result of another new 13-week study; and the fact that lutein esters from Tagetes erecta are considered to be substitutional for other lutein extracts. The Committee considered establishing a group ADI “not specified” for lutein esters from Tagetes erecta that would include lutein from Tagetes erecta and synthetic zeaxanthin and related xanthophylls, but this would be possible only when the specifications for lutein esters from Tagetes erecta are finalized. The Committee established a temporary ADI “not specified” for lutein esters from Tagetes erecta. The ADI was made temporary because the specifications for lutein esters from Tagetes erecta were tentative.

Meeting:

79

Specs Code:

N,T

Report: 

Tox Monograph: 

Specification: