Elemental impurities in traditional Chinese medicines (TCMs)

Traditional Chinese medicines (TCMs) sold in Australia are carefully regulated to ensure safety and quality. They must meet limits on impurities like lead, arsenic, cadmium, and mercury, which can be absorbed by plants. To protect consumers, the Therapeutic Goods Administration (TGA) requires TCMs to comply with national and international guidelines that set safe daily limits for these impurities. 

Information for consumers

TCMs are popular herbal treatments, but they need to be used safely. TCMs listed on the Australian Register of Therapeutic Goods (ARTG) must meet strict safety rules, including limits on heavy metals like lead, arsenic, cadmium, and mercury. These limits are based on daily exposure levels to protect consumers from potentially harmful levels of these metals. 

• To help protect your health, always follow dosage instructions and consult a healthcare professional if you have questions.
• If you think you may be experiencing a side effect after using a TCM, seek advice from a health professional. You or your health professional can then report it to us. 
• Detailed information on how and what to report is available at Report a problem or side effect.

Information for sponsors

Sponsors should consider the permissible daily exposure limits for certain elemental impurities, such as heavy metals, in their TCM products. 

Permissible daily exposure (PDE) limits

• Elemental impurities are measured in parts per million (ppm).
• ‘ppm’ doesn’t account for how much elemental impurities a consumer gets based on how much medicine they take each day. This is important for TCM pills because they often need to be taken in large doses.
• Large doses of TCM pills can result in higher intake of these impurities, even if the ppm is within safe limits. 
• PDE accounts for a consumer’s total daily exposure, ensuring elemental impurity levels are safe even when large doses are taken.

More information

• Maximum concentration limits for elemental impurities can be found in Schedule 3, Part 6 of Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101)
• PDE limits for each elemental impurity can be found in:
  • United States Pharmacopeia’s Chapter 2232 (USP 2232); or
  • ICH Q3D Elemental impurities – Scientific guideline (see Appendix 2)

Carefully review the information above along with the product specifications for all TCMs you have listed on the Australian Register of Therapeutic Goods (ARTG). If your medicine contains elemental impurities, you should:

1. Check that it meets the PDE requirements
2. Stop supplying any medicine(s) that do not meet these requirements
3. Notify the TGA (via Report a medicine or vaccine defect) if your testing shows that PDE requirements are exceeded
4. Take steps to make sure future batches of the medicine(s) comply.

The TGA routinely monitors listed medicines and selects them for compliance reviews. Consequences for non-compliance with relevant laws include not only cancellation from the ARTG and financial penalties, but also civil or criminal proceedings.