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Introduction
The levels at which toxins and impurities must be controlled in medicinal cannabis plant products are defined in Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) (TGO93). The survey described in this report was conducted to test for the presence of selected toxins as specified in subsection 12(1) of TGO93 for medicinal cannabis plant products.
Testing
Products that met the description of dried cannabis, floss or buds were targeted in this survey. Details of the samples received for testing are outlined in Appendix A. At the time of requesting, samples for two of the requested products were not provided. This is due to one product been discontinued and no stock being available for the other. Sample details and the reasons for not providing a sample are given in Appendix B.
A total of six medicinal cannabis floss products were tested by an accredited third-party testing laboratory. Testing on each of the received medicinal cannabis products assessed the quality, and conformance with selected tests in subsection 12(1) of TGO 93. Samples were tested for the presence and quantity of aflatoxins, ochratoxin A, heavy metals and pesticides.
The limits for the specified toxins are outlined in Table 1.
| Parameter | Test Method | Limit |
|---|---|---|
| Aflatoxins | Ph Eur12.8.18 | Not more than 2 µg/kg of aflatoxin B1 and not more than 4 µg/kg for the sum of aflatoxins B1, B2, G1, G2 |
| Heavy metals | Ph Eur 2.4.27 | Not more than 3.0 mg/kg of arsenic, Not more than 0.5 mg/kg of cadmium, Not more than 5.0 mg/kg of lead, Not more than 0.5 mg/kg of mercury |
| Ochratoxin A | Ph Eur 2.8.22 | Not more than 20 µg/kg |
| Pesticides | Ph Eur 2.8.13 | Not more than the limits specified in Ph Eur 2.8.13 |
1European Pharmacopoeia
Conclusion
All six samples met the requirements of TGO93 for aflatoxins, ochratoxin A, heavy metals and pesticides.
Appendices
Appendix A: Details of samples received for testing
Appendix B: Details and reasons for not proving a sample
Appendix C: Summary of Assay Results Pesticides, Aflatoxins, Ochratoxin A and Heavy Metals
| Product Name | Batch Number | Expiry Date | Supplier |
|---|---|---|---|
| Cannatrek T15 Flower (Sativa Acadia) 15.0% THC Flos for Inhalation | 9415(3) | 30 November 2021 | Cannatrek Medical Pty Ltd |
| Bedrocan Dried Cannabis Flos for Inhalation (22% THC OAB,2, < 1% CBD OAB) | 20E04EY20G22 | 07/2021 | Novachem Pty Ltd |
| Beacon Medical "THC+F" Dried Flower Bud (THC 20% w/w, <0.1% w/w CBD) | 935SI22302 | Jun 2022 | Burleigh Heads Cannabis Pty Ltd |
| MEDCAN CC01 Dried Cannabis Flower (THC 22%, CBD 0.07%) | MCA-AGM-CC01-B2 | 19 August 2021 | Medcan Australia |
| Tilray Whole Flower Dried Cannabis THC 25 (THC 25%, CBD NMT 0.5%) | N0000010614 | 10/2021 | Tilray Inc. |
| Tilray THC10: CBD10 Whole Flower Dried Cannabis (THC9.9%, CBD9.6%) | N0000010076 | 07/2021 | Tilray Inc. |
2On as is basis
| Supplier | Requested Sample | Reason for not being provided |
|---|---|---|
| Cannatrek Medical | Cannatrek T20 Flower (Indica Mongolian) 18.5% THC, less than 0.07% CBD | Product has been discontinued, and no stock available |
| Althea Company Pty Ltd | Althea Henik (Tetrahydrocannabinol 18% Cannabidiol less than 1%) | Product not supplied as awaiting supply, pending import. |
| Product Name | Pesticides | Aflatoxins and Ochratoxin A (µg/kg) | Trace Elements (mg/kg) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Aflatoxin B1 | Aflatoxin B2 | Aflatoxin G1 | Aflatoxin G2 | Aflatoxins B1+B2+G1+G2 | Arsenic | Cadmium | Lead | Mercury | ||
| Tilray THC10: CBD10 Whole Flower Dried Cannabis (THC9.9%, CBD9.6%) | <LOR,3,4 | <2 | <2 | <2 | <2 | <4 | <0.05 | <0.05 | 0.15 | <0.05 |
| Cannatrek T15 Flower (Sativa Acadia) 15.0% THC Flos for Inhalation | <LOR | <2 | <2 | <2 | <2 | <4 | <0.05 | <0.05 | <0.05 | <0.05 |
| Bedrocan Dried Cannabis Flos for Inhalation (22% THC OAB, < 1% CBD OAB) | <LOR | <2 | <2 | <2 | <2 | <4 | <0.05 | <0.05 | <0.05 | <0.05 |
| MEDCAN CC01 Dried Cannabis Flower (THC 22%, CBD 0.07%) | <LOR | <2 | <2 | <2 | <2 | <4 | <0.05 | <0.05 | <0.05 | <0.05 |
| Beacon Medical "THC+F" Dried Flower Bud (THC 20% w/w, <0.1% w/w CBD) | <LOR | <2 | <2 | <2 | <2 | <4 | <0.05 | <0.05 | <0.05 | <0.05 |
| Tilray Whole Flower Dried Cannabis THC 25 (THC 25%, CBD NMT 0.5%) | <LOR | <2 | <2 | <2 | <2 | <4 | <0.05 | <0.05 | 0.14 | <0.05 |
3Limit of Reporting
4All pesticides stated in Ph Eur. 2.8.13 were <LOR
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | TGA Laboratories | August 2021 |