The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Name of the ingredient
Refined Buglossoides arvensis seed oil.
Definition of the ingredient
Refined Buglossoides arvensis seed oil is a refined triglyceride oil derived from the seeds of Buglossoides arvensis in which the polyunsaturated fatty acids, alpha-linolenic acid (44%), stearidonic acid (20%), and linoleic acid (13%) are the main fatty acids, with smaller amounts of oleic acid, gamma-linolenic acid, and saturated fatty acids. The substance is manufactured through either a cold press process or by solvent extraction.
Table 1. Ingredient specific requirements
|
Test |
Method reference |
Acceptance criteria |
|---|---|---|
|
Description |
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Appearance |
Visual |
Pale Yellow Liquid |
|
Odour |
Organoleptic |
Characteristic |
|
Color |
AOCS Cc 13j-97 |
<2.0 R; <20.0 Y |
|
Characteristics |
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Moisture and volatiles |
AOCS Ca 2e-84 |
<0.2% |
|
Solubility in water |
Visual |
Insoluble |
|
Refractive index |
AOCS Cc 7-25 |
1.4860 @ 20°C |
|
Specific gravity |
AOCS Cc 1a-64 |
0.9337 @ 20°C |
|
Viscosity |
AOCS Tq 1a-64 |
42-49 cps |
|
Flash point |
AOCS Cc 9b-55 |
180-190°C |
|
Melamine |
FDA LIB 4422 |
<0.05 mg/Kg |
|
Cyanuric acid |
FDA LIB 4422 |
<0.25 mg/Kg |
|
Tocopherol and tocotrienol |
DGF F-II 4a |
250-550 mg/Kg |
|
Identification |
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Genetic and taxonomic validation of seeds and plants |
Seed genetics, morphology, AHP voucher specimen |
Pass >98% purity |
|
Fatty acid composition |
AOCS Ce 1h-05 |
All levels must be in range simultaneously: Stearidonic acid (c18:4n-3) 17-21% |
|
Assay |
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|
Trans fatty acids |
AOCS Ce 1h-05 |
Not more than 2.0% (w/w) of total fatty acids |
|
Acid value |
AOCS Cd 3d-63 |
Not more than 0.6 mg KOH/g |
|
Free Fatty Acids |
AOCS Ca 5a-40 |
Not more than 0.3% |
|
Oxidative Stability Index |
AOCS Cd 12b-92 |
30-34 hrs @ 75°C |
|
Glycerol |
AOCS Cd 11c-93 |
<1.1% |
|
Monoglycerides |
AOCS Cd 11c-93 |
<4% |
|
Epoxy fatty acids |
AOCS Ce 1h-05 |
<0.1% |
|
Diglycerides |
AOCS Cd 11c-93 |
>2% - <9% |
|
Triglycerides |
AOCS Cd 11c-93 |
>89% - <99% |
|
Sterols |
ISO 12228 |
<5000 mg/Kg |
|
Peroxide value (PV) |
AOCS Cd 8-53 |
Not more than 5 mEq/Kg |
|
p-Anisidine value (p-AnV) |
AOCS Cd 18-90 |
Not more than 15 |
|
TOTOX value |
2PV + p-AnV |
Not more than 20 |
|
Unsaponifiable content |
AOCS Ca 6a-40 |
Not more than 1.5% |
|
Protein content |
CBQCA Protein quantification kit[1] |
Not more than 10 µg/mL |
|
Pyrrolizidine alkaloids |
HPLC-MS[2] |
Not detectable with a detection limit of 1 µg/Kg |
|
Erucic acid |
AOCS Ce 1h-05 |
Not more than 1.0% |
|
Iodine value |
AOCS Cd 1c-85 |
210-250 cg/g |
|
Cold Test |
AOCS Cc 11-53 |
>5.5 hr @ 0°C |
Table 2. Incidental constituents
|
Test |
Method reference |
Acceptance criteria |
|---|---|---|
|
Residual Solvents |
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|
Hexane |
AOCS Ca 3b-87 |
<1 mg/Kg |
|
Incidental metals and non-metals |
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Lead |
AOAC 993.14 / ICP-MS |
Not more than 0.1 ppm |
|
Arsenic |
AOAC 993.14 / ICP-MS |
Not more than 0.1 ppm |
|
Cadmium |
AOAC 993.14 / ICP-MS |
Not more than 0.1 ppm |
|
Mercury |
AOAC 993.14 / ICP-MS |
Not more than 0.1 ppm |
|
Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) |
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Pesticides |
Ph. Eur. 2.8.13; AOAC 2007.01 |
No detection |
|
Other organic impurities or toxins |
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Sum of dioxins |
WHO-PCDD/F-TEQ[3] |
Not more than 0.75 pg/g |
|
PCBs (209 congeners) |
US EPA 1668 |
Not more than 0.09 mg/Kg |
|
WHO-12 PCBs + ICES6 PCBs (Sum of PCB congeners 28, 52, 101, 138, 153, 180) |
FDA PAM 304 E3C5 |
Not more than 40 ng/g |
|
PAHs |
GC-MS |
<2.0 ug/Kg for benzo(a)pyrene <10 ug/Kg for total PAHs (i.e., sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene, and chrysene) |
|
Microbiology |
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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. 100 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 11 of the Order. |
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Footnotes:
- Rigby, N.M., Sancho, A.I., Salt, L.J., Foxall, R., Taylor, S., Raczynski, A., Cochrane, S.A., Crevel, R.W. and Mills, E.C., 2011. Quantification and partial characterization of the residual protein in fully and partially refined commercial soybean oils. Journal of agricultural and food chemistry, 59(5), pp.1752-1759.
- Cramer, L., Schiebel, H.M., Ernst, L. and Beuerle, T., 2013. Pyrrolizidine alkaloids in the food chain: development, validation, and application of a new HPLC-ESI-MS/MS sum parameter method. Journal of agricultural and food chemistry, 61(47), pp.11382-11391.
- The sum of the toxic equivalencies of the 17 most toxicologically significant dioxins and furans.
Key to abbreviations:
AHP = American Herbal Pharmacopoeia
AOAC = Association of official agricultural chemists
BP = British pharmacopoeia
CBQCA = 3-(4-Carboxybenzoyl)quinoline-2-carboxaldehyde
cps = Centipoise
DGF = German standard (oil and fat analysis)
FDA PAM = United States Food and drug administration - Pesticide Analytical Manual
FDA LIB = United States Food and drug administration - Laboratory information bulletin
GC = Gas chromatography
hr = Hours
HPLC = High pressure liquid chromatography
HPTLC = High performance thin layer chromatography
ICES = International council for the exploration of the sea
ICP = Inductively coupled plasma
IR = Infrared spectrophotometry
ISO = International organisation for standardisation
mEq = Milliequivalent
MS = Mass spectrometry
PAHs = Polycyclic aromatic hydrocarbons
PCBs = Polychlorinated biphenyls
PCDD = Polychlorinated dibenzodioxin
Ph. Eur. = European pharmacopoeia
ppm = Parts per million
TEQ = Toxic equivalency factor
TOTOX value = Total oxidation value
US EPA = United States Environmental protection agency
USP = United States pharmacopoeia
WHO = World health organisation