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Testing for toxins in medicinal cannabis products being supplied via SAS B in Australia

26 August 2021

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.

Table 1. Summary of AusPAR required by application category and types
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

Appendix A: Details and results of samples analysed
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

Appendix B: Details and reasons for not proving a sample
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.

Appendix C: Summary of Assay Results Pesticides, Aflatoxins, Ochratoxin A and Heavy Metals
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 history
Version Description of change Author Effective date

V1.0

Original publication

TGA Laboratories

August 2021