beta,beta-CAROTENE

Comments:

Considered for dietary exposure only.

Intake:

The estimates of dietary exposure to β-carotenes (INS No. 160a(i–iv)) based on typical use levels and food consumption data from individuals were higher at the upper end of the range of dietary exposures considered at the 102nd meeting than those considered at the eighty-seventh meeting. In the absence of an ADI for β-carotenes, the toxicological relevance of this finding of the higher estimates of dietary exposure cannot be characterized

Meeting:

102

Specs Code:

No

ADI:

WITHDRAWN

Comments:

The Committee reaffirmed the conclusion from the eighty-fourth meeting that rats are not an appropriate model for deriving an ADI for β-carotene due to the relatively low bioavailability of β-carotene in rats compared with humans. Therefore, the Committee withdrew the two group ADIs of 0–5 mg/kg bw for (1) the sum of the synthetic carotenoids β-carotene, β-apo-8′-carotenal and β-apo-8′-carotenoic acid methyl and ethyl esters and (2) synthetic β-carotene and β-carotene derived from Blakeslea trisporae, which were based on a no-observed-adverse-effect level (NOAEL) from a rat study. The Committee was unable to establish a group ADI for synthetic βcarotene, β-carotene derived from B. trispora, β-carotene-rich extract from D. salina, and β-apo-8′-carotenoic acid methyl and ethyl esters because a group ADI is applicable to the general population, which includes heavy smokers. The Committee noted that it is very unlikely that it will ever be possible to establish a group ADI because further data from the population of heavy smokers cannot be gathered ethically.

Meeting:

87

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

0-5 mg/kg bw

Comments:

Group ADI for beta-carotene (synthetic) and beta-carotene from Blakeslea trispora

Report: 

Tox Monograph: 

Specification: 

Previous Years: