Name of the ingredient
Fish oil - natural (ABN)
Definition of the ingredient
The substance is the purified fatty oil obtained from fish of families including but not limited to Ammodytidae, Carangidae, Clupeidae, Engraulidae, Osmeridae, Salmonidae1 and Scombridae. Suitable antioxidants may be added.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Pale yellow liquid |
| Odour | Organoleptic | Fishy |
| Characteristics | ||
| Solubility | BP (General notice) | Practically insoluble in water, very soluble in acetone and in heptane, slightly soluble in anhydrous ethanol |
| Identification | ||
| Chromatograms obtained in the assay for EPA and DHA | Ph Eur method 2.4.29 | Complies2 |
| Assay | ||
| Sum of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) | BP (Appendix X P); Ph Eur method 2.4.29 | ≥ 10.0%3 |
| Total omega-3-acids | BP (Appendix X P); Ph Eur method 2.4.29 | ≥ 14.0%3 |
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Notes:
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| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Solvent residues | Ph Eur method 2.4.24 | Complies |
| Incidental metals and non-metals | ||
| Lead | Ph Eur method 2.4.27 | ≤ 0.5 ppm |
| Arsenic | ≤ 1 ppm | |
| Cadmium | ≤ 0.5 ppm | |
| Mercury | ≤ 0.5 ppm | |
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) |
Ph Eur method 2.8.13 | Complies |
| Other organic or inorganic impurities or toxins | ||
| Oligomers | Ph Eur method 2.3.304 | ≤ 1.5% |
| Acid value | Ph Eur method 2.5.1 (in 20 g of the oil) | ≤ 2.0 |
| Peroxide value | Ph Eur method 2.5.5 (Method A) | ≤ 10.0 |
| Anisidine value | Ph Eur method 2.5.36 | ≤ 30.0 |
| Unsaponifiable matter | Ph Eur method 2.5.7 (in 5 g of the oil) | ≤ 1.5% |
| Dioxins, furans and polychlorinated biphenyls (PCBs) | USP monograph for 'Fish oil containing Omega-3 Acids' | Complies |
| 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. | |
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Notes:
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Additional comments
The TGA recognises the following Fish Oil monographs:
Refined fish oil, namely:
- Fish Oil, Rich in Omega-3-Acids (BP) as the official standard applying to fish oils containing minimum 28% total omega-3 acids expressed as triglycerides, and
- Farmed Salmon Oil (BP),
and
Reconfigured fish oil, namely, Omega-3-Marine Triglycerides (BP).
The TGA adopted synonym for the material covered in this BP monograph is 'Concentrated Omega-3 triglycerides-fish' (AAN).
All other fish oils that do not meet the definition of the substances that are the subject of the above monographs should meet the specification in the TGA compositional guideline for Fish oil - natural.
Key to abbreviations
BP = British Pharmacopoeia
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
Print version
This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/compositional-guidelines/fish-oil-natural