CI FOOD ORANGE 7
Overview
Chemical Names
beta-apo-8'-Carotenoic acid methyl/ethyl ester, methyl/ethyl 8'-apo-beta-Caroten-8'-oate
Synonyms
C.I. Food Orange 7 (Ethyl ester)
INS
160f
Functional Class
Food Additives
COLOUR
COLOUR
INS matches
160f
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ADI:WITHDRAWN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WITHDRAWN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. Because β-apo-8′-carotenoic acid methyl and ethyl esters were previously
evaluated on the basis of β-carotene and because no new data were
submitted, the Committee was unable to complete an evaluation on βapo-8′-carotenoic acid methyl and ethyl esters.
Meeting:
87
Specs Code:
R
Report:
Tox Monograph:
Specification:
Evaluation year: 2011
ADI:
0-5 mg/kg bw
Comments:
Only specifications evaluated and revised
Specs Code:
R
Report:
Specification:
Evaluation year: 1974
ADI:
0-5 mg/kg bw
Comments:
Group ADI expressed as the sum of the carotenoids: beta-carotene, beta-apo-8'-carotenal and beta-apo-8'-carotenoic acid, methyl and ethyl esters
Report:
Tox Monograph:
Specification:
Previous Years:
1984, FNP 31/1-JECFA 28/17. R; COMPENDIUM/153 (ETHYL ESTER)
1981, FNP 19-JECFA 25/68. R (ETHYL ESTER)
1974, NMRS 54/TRS 557-JECFA 18/16, FAS 7/NMRS 54B-JECFA 18/20, FAS 6/NMRS 54A-JECFA 18/72. 0-5 (GROUP ADI EXPRESSED AS THE SUM OF THE CAROTENOIDS: beta-CAROTENE, beta-apo-8'-CAROTENAL AND beta-apo-8'-CAROTENOIC ACID, METHYL AND ETHYL ESTERS). FU. R
1966, NMRS 43/TRS 373-JECFA 10/27. 0-2.5 (CONDITIONAL, 2.5-5.0). CO
1964, NMRS 38/TRS 309-JECFA 8/22, FAS 66.25/NMRS 38B-JECFA 8/43. N
1984, FNP 31/1-JECFA 28/17. R; COMPENDIUM/153 (ETHYL ESTER)
1981, FNP 19-JECFA 25/68. R (ETHYL ESTER)
1974, NMRS 54/TRS 557-JECFA 18/16, FAS 7/NMRS 54B-JECFA 18/20, FAS 6/NMRS 54A-JECFA 18/72. 0-5 (GROUP ADI EXPRESSED AS THE SUM OF THE CAROTENOIDS: beta-CAROTENE, beta-apo-8'-CAROTENAL AND beta-apo-8'-CAROTENOIC ACID, METHYL AND ETHYL ESTERS). FU. R
1966, NMRS 43/TRS 373-JECFA 10/27. 0-2.5 (CONDITIONAL, 2.5-5.0). CO
1964, NMRS 38/TRS 309-JECFA 8/22, FAS 66.25/NMRS 38B-JECFA 8/43. N