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Compositional guideline: DHA-rich oil derived from microalgae Schizochytrium sp.

18 January 2018

Name of the ingredient

Docosahexaenoic acid (DHA) - rich oil derived from microalgae Schizochytrium sp. (AAN)

Definition of the ingredient

DHA-rich oil derived from microalgae Schizochytrium sp. is the winterised, deodorised oil derived from cultivated Schizochytrium sp. Due to taxonomical name changes made to the genus Schizochytrium, and for the purposes of this Compositional Guideline, the following genus and species are considered to be included: Schizochytrium aggregatum, Aurantiochytrium limacinum, Aurantiochytrium mangrovei, Oblongichytrium minutum, Oblongichytrium octosporum.

Table 1. Ingredient specific requirements
Test Method reference Acceptance criteria
Description
Appearance Visual Semi-solid to liquid oil, yellow–dark orange colour
Odour Organoleptic Characteristic odour
Characteristics
Moisture and volatiles AOCS Ca 2c - 25 ≤ 0.05% w/w
Identification
Fatty acid composition AOCS Ce 1b - 89 Complies, matches spectrum of authenticated reference material
Assay
DHA (22:6 n-3) AOCS Ce 1b - 89 (GC) ≥ 350 mg/g
Free fatty acids AOCS Ca 5a - 40 ≤ 0.25% w/w
Trans fatty acids AOCS Cd 14 - 95 ≤ 1% w/w
Table 2. Incidental constituents
Test Method reference Acceptance criteria
Incidental metals and non-metals
Lead AOCS Ca 17 - 01 ≤ 0.1 ppm
Arsenic AOCS Ca 17 - 01 ≤ 0.1 ppm
Cadmium AOCS Ca 17 - 01 ≤ 0.1 ppm
Mercury AOAC 974.14 and 975.15 ≤ 0.04 ppm
Other organic or inorganic impurities or toxins
Peroxide value AOCS Cd 8 – 53 ≤ 5 meq/kg
Totox value USP <401> ≤ 26 meq/kg
Unsaponifiable matter AOCS Ca 6b - 53 ≤ 4.5% w/w
Nitrogen AOAC 988.05 ≤ 0.02%
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product which contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

Key to abbreviations:

AOAC = Association of Analytical Communities

AOCS = American Oil Chemists' Society

GC = Gas chromatography

USP = United States Pharmacopoeia