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Euglena gracilis is a single-celled organism capable of photosynthesis and heterotrophy. Euglena sp. have long been studied in the laboratory for its metabolic pathways, cell motility, and ease of culture. The safety of E. gracilis strain eu029 (EG029) for use as a food ingredient was assessed in a bacterial reverse mutagenesis assay (Ames), rec assay, in vivo micronucleus assay, acute toxicity study in mice, 13-week toxicology in rats, and a teratology study in mice and rats. EG029 was not genotoxic. The No Observed Adverse Effect Level (NOAEL) in the 13-week study was greater than 1000 mg/kg/day, the highest dose tested. Teratogenicity studies did not find any defects in fetal development or effects to maternal health in rats at 1000 mg/kg/day, the highest dose tested.

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A safety assessment for β-galactosidase derived from Aspergillus oryzae (GODO-FAL) was performed. The test article was a concentrated, purified β-galactosidase diluted in glycerin and water with an activity of 10,000 U/mL. A series of genotoxicology tests including micronucleus assay, chromosome aberration assay, and reverse mutagenesis (Ames) assay confirmed that GODO-FAL was not clastogenic or mutagenic at any of the concentrations used, up to 2000 µg/mL for the chromosome aberration assay and 5000 mg per plate in the Ames assay. GODO-FAL was not toxic in acute, repeated oral toxicity, and sub-chronic toxicity assays in Sprague–Dawley rats at any dose used, up to 2000 mg/kg/day. Based on results from the subchronic toxicology assay, the no observed adverse effects level for GODO-FAL was at least 2000 mg/kg/day.

A safety assessment of the dried whole cell biomass of Euglena gracilis ATCC 12894 was performed by the bacterial reverse mutation (Ames) assay, an in vitro micronucleus assay, and a 90-day repeat oral toxicity study in Wistar rats. E. gracilis ATCC 12894 whole cell biomass has no added excipients and contains 33.8% protein, 28.8% -glucans, 19.8% fat, 7.1% ash, and 2.8% moisture. The bacterial reverse mutation assay found no evidence of mutagenicity after exposure to E. gracilis ATCC 12894 whole cell biomass, with or without metabolic activity, at levels up to 1581 mg/plate, the limit dose for the assay. Similarly, no evidence of genotoxicity was observed in the micronucleus assay, with or without metabolic activation, up to 320 mg/mL, the limit dose for the assay. The subchronic toxicity study was performed with the following test article dose groups: 0 (control), 1250, 2500, and 5000 mg/kg/day, administered to male and female Wistar rats via oral gavage for 90 days. No test article-related mortalities or adverse events were reported during the study. Histopathological examination revealed some vacuolation in the livers of males in the 5000 mg/kg/day group. This finding was considered adaptive, due to the approximately 20% fat content of whole cell biomass, and was therefore test articlerelated, but not adverse. No such findings were reported in female rats in the study. The results of the subchronic toxicity study describe a no observed adverse effect level of at least 5000 mg/kg/day.