ANNATTO EXTRACTS

Comments:

ADI for bixin is applicable to the following annatto extracts, provided they comply with the respective specifications: - solvent-extracted bixin (= 85% bixin, = 2.5% norbixin) - aqueous processed bixin (= 25% bixin, = 7% norbixin) and does not apply to oil-processed bixin (=10 % bixin) Group ADI for norbixin and its sodium and potassium salts is applicable to the following annatto extracts, provided they comply with the respective specifications: - solvent-extracted norbixin (= 85% norbixin) - alkali-processed norbixin, acid-precipitated (= 35% norbixin) and not acid precipitated (= 15% norbixin) In re-evaluating the studies of toxicity with solvent-extracted bixin (92% bixin) and solvent-extracted norbixin (91.6% norbixin) and in light of the additional compositional data, JECFA considered that ADIs could be allocated to these pigments, on the basis of studies conducted on the extracts. As no NOEL could be identified for oil-processed bixin and no compositional data were available, JECFA decided that the above evaluation could not be applied to this extract.

Intake:

2006, TRS 940-JECFA 67/11, FAS for JECFA 67 in press. If all the pigment ingested were bixin, the estimated dietary exposure of 1.5 mg/day would result in an intake of bixin of 26 µg/kg bw per day, corresponding to approximately 0.2% of the ADI (0.12 mg/kg bw). Similarly, if all the pigment were norbixin, the estimated dietary exposure of 1.5 mg/day would result in an intake of norbixin of 26 µg/kg bw per day, corresponding to approximately 4% of the ADI (0.0.6 mg/kg bw). 1999, TRS 896-JECFA 53/96,121; FAS 44-JECFA 53/485. Intake estimates based on food additive levels in the draft General Standard for Food Additives being developed by the Codex Committee on Food Additives and Contaminants, integrated with national food consumption data, exceeded the ADI of 0-0.065 mg/kg bw, expressed as bixin. Intake assessments based on national permitted levels would not exceed the ADI for most population groups. Data from Brazil, however, provided evidence that 28% of the population consume annatto seeds directly as a condiment and have chronic intakes of the order of 150% of the ADI.

Meeting:

46

Specs Code:

R (1996)

Report: 

Tox Monograph: 

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