beta,beta-CAROTENE
Overview
Synonyms
beta-Carotene; beta,beta-Carotene; C.I. Food Orange 5; Carotenes
INS
160a(iii)
Functional Class
Food Additives
COLOUR
COLOUR
INS matches
160a(iii)
Evaluations
Evaluation year: 2019
ADI:WITHDRAWN
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WITHDRAWN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:
Evaluation year: 2001
ADI:
0-5 mg/kg bw
Comments:
Group ADI for beta-carotene (synthetic) and beta-carotene from Blakeslea trispora
Report:
Tox Monograph:
Previous Years:
2001, COMPENDIUM ADDENDUM 9/FNP 52 Add.9/9. N,T
2001, COMPENDIUM ADDENDUM 9/FNP 52 Add.9/9. N,T