beta-CAROTENE-RICH EXTRACT FROM DUNALIELLA SALINA
General Information
| Chemical Names: | beta-CAROTENE-RICH EXTRACT FROM DUNALIELLA SALINA; β-CAROTENE-RICH EXTRACT FROM DUNALIELLA SALINA |
| Functional Class: |
Food Additives COLOUR |
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Evaluations
| Evaluation year: | 2017 |
| ADI: | NOT SPECIFIED |
| Meeting: | 84 |
| Specs Code: | N |
| Comments: | The Committee noted that data have become available since the previous evaluation that show large differences in absorption of β-carotene between rodents and humans. The Committee considered that rodents are inappropriate animal models for establishing an ADI for β-carotene. The Committee noted that the toxicity of the other components of the β-carotene-rich d-limonene extract of D. salina (hereafter referred to as D. salina d-limonene extract) can be evaluated using the results of rodent studies. A short-term toxicity study in rats gave a NOAEL of 3180 mg/kg bw per day, the highest dose tested. No long-term toxicity or reproductive studies have been conducted. The D. salina d-limonene extract did not show genotoxicity or developmental toxicity. Correction of the NOAEL of 3180 mg/kg bw per day for the percentage of the algal component (20–35%) gives an adjusted NOAEL of 636–1113 mg/kg bw per day for the algal lipid component of the D. salina d-limonene extract. The margin of exposure for this algal lipid component is 2120–3710 using a dietary exposure of 18 mg/day (0.3 mg/kg bw per day). The Committee concluded that exposure to the algal component of the extract does not pose a health concern. The Committee noted that the total dietary exposure to β- carotene is not expected to increase when D. salina dlimonene extract is used as a food colour. The Committee concluded that there was no health concern for the use of β-carotene-rich extract from D. salina when used as a food colour in accordance with the specifications established at this meeting. The Committee emphasized that this conclusion applies to the use of this extract as a food colour, not as a food supplement. |
| Report: | TRS 1007-JECFA 84/16 |
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