What changed
The Industrial Chemicals Environmental Management (Register) Amendment (2026 Measures No. 1) Instrument 2026 (F2026L00750) adds three PFAS chemical classes to Schedule 7 of the IChEMS Register:
- perfluoroheptanesulfonic acid (PFHpS), its salts, and substances containing a PFHpS-related moiety;
- perfluorononanesulfonic acid (PFNS) and perfluorodecanesulfonic acid (PFDS), their salts, and substances containing the relevant sulfonyl moieties.
The entries commence on January 1, 2027. The instrument restricts manufacture, import, export, and use of the listed chemical classes, including when they are present in mixtures or articles, subject to the exceptions set out in the instrument.
What the instrument does and does not establish for medical devices
The IChEMS amendment itself does not say that the Therapeutic Goods Administration has confirmed a blanket exemption for medical devices. It also does not create a separate “non-medical device” category.
The related Industrial Chemicals Act 2019 uses a purpose-based distinction: “industrial use” excludes use as a therapeutic good or in preparing one. That distinction may be relevant where a listed chemical is used in a therapeutic good, but it is not a general exemption for every product, component, material, or activity connected with a medical-device business.
For a medical-device manufacturer, the result therefore depends on the specific chemical use and product role. A finished device supplied as a therapeutic good, an industrial component supplied to a device manufacturer, a laboratory or production aid, and a non-medical article may not have the same regulatory analysis. The sources reviewed here do not support a blanket statement that all finished devices and validated component parts are outside IChEMS or never require further assessment.
Restrictions and exceptions
For PFHpS, PFNS, and PFDS, the instrument provides limited exceptions for unintentional trace contamination, research or laboratory purposes, environmentally sound disposal, and articles already in use on or before January 1, 2027. The instrument also sets concentration thresholds and waste-management conditions that differ by chemical class and activity.
What manufacturers should check now
Map each chemical use
Identify whether a listed substance is used as part of a therapeutic good, in an industrial process, in a component supplied to another manufacturer, or in a non-medical article. Do not decide scope solely from the product’s marketing name or TGA status.
Separate finished goods from components and operations
Review bills of materials, imported articles, production aids, laboratory materials, and waste streams separately. A finished device analysis may not resolve the obligations of a chemical supplier or an industrial process using the same substance.
Record the basis for any exclusion or exception
If the business concludes that a use is outside the industrial-chemical framework or falls within an instrument exception, retain the legal basis, product description, concentration information, and supply-chain evidence supporting that conclusion. Escalate ambiguous cases for Australian regulatory advice before relying on a “medical-device exemption.”
Sources
The 2026 amendment instrument is the primary source for the three PFAS entries, restrictions, thresholds, and commencement date. The Industrial Chemicals Act 2019 and the Industrial Chemicals Environmental Management (Register) Act 2021 provide the statutory context for assessing whether a particular chemical use is industrial and how IChEMS scheduling operates.
Sources
- Primary official sourceIndustrial Chemicals Environmental Management (Register) Amendment (2026 Measures No. 1) Instrument 2026 (opens in a new tab)Department of Climate Change, Energy, the Environment and Water
- Supporting sourceIndustrial Chemicals Act 2019 (opens in a new tab)Australian Government
- Supporting sourceIndustrial Chemicals Environmental Management (Register) Act 2021 (opens in a new tab)Australian Government