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
Leptospermum scoparium oil (AHS)
Definition of the ingredient
This compositional guideline is specific to the oil derived by steam distillation from the crushed leaves and terminal branches of the Manuka tree Leptospermum scoparium. There are no other extraction processes or ingredients added to the oil.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Clear yellow liquid |
| Characteristics | ||
| Relative density | BP (Appendix V G) | 0.95 – 0.98 g/mL at 20°C |
| Refractive index | BP (Appendix V E) | 1.4960 – 1.5060 |
| Identification | ||
| Chemical 'fingerprint' | GC[1] | Complies with authenticated reference material |
| Assay | ||
| α-Cubebene | GC[1] | 2.0 - 7.0% w/w |
| α-Copaene | GC[1] | 2.5 - 7.5% w/w |
| β-Selinene | GC[1] | 1.0 - 6.0% w/w |
| α-Selinene | GC[1] | 2.0 - 7.0% w/w |
| Calamanene | GC[1] | 9.0 - 18.0% w/w |
| δ-Cadinene | GC[1] | 3.0 - 8.0% w/w |
| Cadina-1,4-diene | GC[1] | 3.0 - 8.0% w/w |
| Flavesone | GC[1] | 3.0 - 8.0% w/w |
| iso-Leptospermone | GC[1] | 2.0 - 7.0% w/w |
| Leptospermone | GC[1] | 10.0 - 20.0% w/w |
| Total triketone content* | GC[1] | ≥25% w/w |
| Notes | ||
|
*Total of flavesone, leptospermone and iso-leptospermone |
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| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual solvents are not tested for** | See notes below** | See notes below** |
| Pesticide residues and environmental contaminants | ||
| Current BP test and limits | BP (Appendix XI L, Pesticide residues) | Complies |
| Incidental metals and non-metals | ||
|
While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary (USP-NF) general chapter '<2232> Elemental Contaminants in Dietary Supplements'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. |
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| 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 that 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 | ||
|
** As the oil is derived by steam distillation from the crushed leaves and terminal branches of the Manuka tree Leptospermum scoparium, and there are no other extraction processes or ingredients added to the oil, there should be no residual solvents. |
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Footnotes
| [1] | As described in: Douglas, M. H., van Klink, J. W., Smallfield, B. M., Perry, N. B., Anderson, R. E., Johnstone, P., & Weavers, R. T. (2004). Essential oils from New Zealand manuka: triketone and other chemotypes of Leptospermum scoparium. Phytochemistry, 65(9), 1255-1264. |
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Abbreviations
AHS = Australian Herbal Substance
BP = British Pharmacopoeia
GC = Gas Chromatography