Updated 'medical devices exempt from PFAS ban' to include other therapeutic goods

Following a number of stakeholder queries, the TGA is providing an updated statement on the PFAS ban. The original statement was published on 27 June 2025.

From 1 July 2025, restrictions under the Industrial Chemicals Environmental Management Standard (IChEMS) will prohibit the import, manufacture and use of three PFAS chemicals in Australia:

• PFOS (perfluorooctane sulfonate)
• PFOA (perfluorooctanoic acid)
• PFHxS (perfluorohexane sulfonate)

These restrictions support Australia’s obligations under the Stockholm Convention on Persistent Organic Pollutants.

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 the primary and secondary packaging associated with the medicine; and
• biologicals, including the primary and secondary packaging associated with the biological

will not be affected by the ban.

The TGA does not regulate environmental safety, 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 due to the IChEMS prohibitions.

More information

For more information contact ichems.enquiry@dcceew.gov.au.