Following stakeholder queries, we are providing an updated statement on the Industrial Chemicals Environmental Management Standard (IChEMS) and the prohibitions relevant to chemicals such as certain PFAS chemicals, UV-328 and Dechlorane Plus.
Previously we published statements of 'medical devices exempt from PFAS ban on 27 June 2025 and 7 July 2025.
IChEMS prohibits the import, manufacture and use of specified chemicals in Australia and support Australia's obligations under the Stockholm Convention on Persistent Organic Pollutants. However, IChEMS does not apply to chemicals used for therapeutic purposes. This means that:
- medical devices, including components in the device, primary packaging, instructions for use, and spare parts
- medicines including complementary medicines, and their primary and secondary packaging associated with the medicine; and
- biologicals, including the primary and secondary packaging associated with the biological
are not affected by the IChEMS prohibitions.
We do not regulate environmental safety and cannot grant exemptions to IChEMS prohibitions, but we encourage manufacturers to reduce the use of IChEMS listed chemicals in medical devices, medicines and biologicals over time. We also encourage sponsors to contact us if they become aware of a potential impact on patients due to a disruption to supply of a medical device, medicine or biological because of the IChEMS prohibitions.
