Name of the ingredient
Euglena gracilis whole cell dry
Definition of the ingredient
Euglena gracilis is a single-celled, spindle-shaped/elongated, filamentous microalgae belonging to the Euglenaceae family. It consists of a single nucleus, chloroplasts with pigments (when grown in light) or proplastids (when grown in the dark), a contractile vacuole, an eyespot, and a single flagellum. Under microscope it appears as a thick-walled oblong-shaped organism. The ingredient is a dried powder of the whole-cell algae fermentate produced through a patented fermentation process (Patent No. US 9,574,217 B2) containing a minimum of 50% algae beta-1,3-glucans.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Free flowing powder, free of foreign material |
| Colour | Visual | Yellow-Tan |
| Odour | Organoleptic | Characteristic of algae |
| Characteristics | ||
| Moisture | Ohaus MB45 Moisture Analyser | ≤6% |
| Protein | Dumas | ≥15% |
| Total Fatty acids | AOAC 922.06, 954.02, 933.05, 925.32 | ≤15% |
| Ash | AOAC 923.03 | ≤10% |
| Identification | ||
| Cellular morphology | Microscopic examination | Identification of paramylon (beta-(1,3)-glucan) granules within characterisitic Euglena gracilis cells |
| Genotypic identity | rDNA sequencing | Conforms to reference DNA-sequence for Euglena gracilis on HERB™ database. |
| Assay | ||
| beta-1,3-glucan | AOAC 991.43 | ≥50% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| The ingredient is produced without the use of extraction solvents. | ||
| Incidental metals and non-metals | ||
| Lead | AOAC 2011.19, AOAC 993.14 |
≤0.5 mg/kg (ppm) |
| Cadmium | AOAC 2011.19, AOAC 993.14 |
≤0.5 mg/kg (ppm) |
| Mercury | AOAC 2011.19, AOAC 993.14 |
≤0.05 mg/kg (ppm) |
| Arsenic | AOAC 2011.19, AOAC 993.14 |
≤0.02 mg/kg (ppm) |
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | ||
| Mycotoxins (Total Aflatoxins: sum of B1, B2, G1, G2) | UHPLC-MS/MS [1] | ≤1 mg/kg |
| PAHs: Benzo(a)pyrene | GC-MS [2] | ≤10 µg/Kg (ppb)[3] |
| PAHs: Sum of benzo(a)- pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene. | GC-MS [2] | ≤50 µg/Kg (ppb)[3] |
| Microbiology | ||
| Aerobic plate count | AOAC 966.23 | ≤10,000 CFU/g |
| Coliforms | FDA-BAM | ≤100 MPN/g |
| Yeast and Mould | FDA-BAM | ≤500 CFU/g |
| Escherichia coli | USP <62> | Negative/10 g |
| Staphylococcus aureus | USP <62> | Negative/10 g |
| Salmonella | USP <62> | Negative/25 g |
| Listeria monocytogenes | AOAC 2004.06 | Negative/25 g |
Footnotes
| [1] | Varga, E., Glauner, T., Koppen, R., Mayer, K., Sulyok, M., Schumacher, R., Krska, R. and Berthiller, F., Stable isotope dilution assay for the accurate determination of mycotoxins in maize by UHPLC-MS/MS, Analytical and BioAnalytical Chemistry, 402:2675-2686 (2012). |
|---|---|
| [2] | Residues quantified using Triple Quad Mass-Spectrometry. Compounds analysed include the following: Benz(a)anthracene, Benzo(a)pyrene, Benzo(b)fluoranthene, Benzo(g,h,i)perylene, Benzo(k)fluoranthene, Chrysene, Dibenz(a,h)anthracene, Indeno(1,2,3-c,d)pyrene, Pyrene. |
| [3] | Limits are based on EU directive Commission Regulation (EC) No 1881/2006 and amendments for food supplements. |
Key to abbreviations
AOAC = Association of official analytical collaboration
BAM = Bacteriological Analytical Manual
FDA = Food and Drug Administration
ICP = Inductively Coupled Plasma
ISO = International organisation for standardisation
MS = Mass spectrometry
PAHs = Polycyclic Aromatic Hydrocarbons
UHPLC = Ultra High-pressure liquid chromatography