beta-CAROTENE (synthetic)

Comments:

JECFA 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, JECFA 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. JECFA 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. JECFA 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:

Only specifications evaluated and revised. Group ADI for beta-carotene (synthetic) and beta-carotene from Blakeslea trispora

Specs Code:

R

Report: 

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: