TGA Clarifies IChEMS Exemptions for Therapeutic Goods

Overview

The Therapeutic Goods Administration (TGA) formally clarified on 14 April 2026 that therapeutic goods are entirely exempt from the prohibitions set out under Australia’s Industrial Chemicals Environmental Management Standard (IChEMS). This clarification confirms that medicines, medical devices, biologicals, and their associated primary and secondary packaging are not subject to the import, manufacture, and use bans that IChEMS places on high-concern persistent organic pollutants (POPs), including specific listed PFAS compounds, UV-328, and Dechlorane Plus. The TGA issued this guidance in direct response to widespread stakeholder confusion about how environmental chemical management obligations interact with the therapeutic goods regulatory framework.

For environmental consultants, contaminated land practitioners, ESG advisors, and legal professionals advising healthcare sector clients, this creates a complex dual-regulatory landscape. The same chemical compound that is prohibited under IChEMS in a general industrial context can be lawfully present in a pharmaceutical or medical device manufacturing facility when it serves a therapeutic purpose. This is a clear distinction, not a pending policy question. It is a confirmed structural feature of how Australian chemical regulation is designed. Understanding it is now a core competency for practitioners conducting environmental due diligence, site assessments, waste audits, and supply chain compliance reviews at healthcare facilities.

The TGA also noted in its clarification that it does not regulate environmental safety and therefore cannot itself issue exemptions under IChEMS. The exemption is inherent in the IChEMS framework, which was designed from the outset to govern industrial chemical use and does not extend to chemicals used in therapeutic applications. Despite the absence of a mandatory phase-out obligation, the TGA is actively encouraging manufacturers to voluntarily reduce reliance on IChEMS-listed chemicals over time where technically feasible alternatives exist. This voluntary encouragement does not carry the same legal weight as a prohibition, and practitioners must be careful not to treat it as such when advising clients on compliance posture.

Key details of the IChEMS framework and therapeutic goods exemption

IChEMS is administered under the Industrial Chemicals Act 2019 (Cth) and functions as Australia’s primary regulatory mechanism for implementing Stockholm Convention obligations relating to high-concern industrial chemicals. The Stockholm Convention is a global treaty targeting POPs, which are chemicals that persist in the environment, bioaccumulate through food chains, and have documented toxicological effects on human health and ecosystems. IChEMS gives domestic legislative effect to the Convention’s prohibitions by restricting the import and manufacture of scheduled chemicals. The chemicals currently within scope of IChEMS prohibitions include specific PFAS compounds, most notably perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), and perfluorohexane sulfonic acid (PFHxS), as well as the flame retardants UV-328 and Dechlorane Plus.

The TGA’s April 2026 clarification makes clear that the IChEMS Standard inherently does not apply to therapeutic goods as defined under the Therapeutic Goods Act 1989 (Cth). This includes finished medicines, implantable and non-implantable medical devices, biologicals such as cell and tissue products, and both primary packaging (materials in direct contact with the therapeutic good) and secondary packaging (outer packaging layers). The exemption is not conditional on the concentration of the listed chemical, the nature of its application, or whether the manufacturer has pursued alternatives. A medical device coating incorporating a listed PFAS compound for performance or biocompatibility reasons is not in breach of IChEMS simply by virtue of that coating’s chemical composition.

What this means in practical terms is that a facility conducting general plastics manufacturing and pharmaceutical packaging on the same site faces two entirely different compliance obligations for what may be chemically identical substances. The general manufacturing line must comply with IChEMS prohibitions. The therapeutic goods production line does not. This is not a loophole. It reflects a deliberate regulatory architecture in which the Therapeutic Goods Act 1989 and IChEMS operate in separate, parallel domains with distinct objectives. Environmental practitioners who conflate these frameworks during site assessments risk producing incorrect compliance findings, potentially advising clients that they are in breach when they are not, or conversely failing to flag genuine non-exempt industrial usage.

One critical boundary that the TGA clarification does not address, but which practitioners must understand, is the disposal pathway. The IChEMS exemption covers import and manufacture. It does not govern what happens to therapeutic goods waste, manufacturing effluent, or packaging materials at end of life. State and territory EPA frameworks, including waste classification schedules and scheduled waste tracking requirements, continue to apply to POP-containing waste regardless of whether the source material was exempt from IChEMS during its useful life. The specific PFAS compounds named under IChEMS are also subject to PFAS National Environmental Management Plan (PFAS NEMP) guidance when they appear in the environment, and that guidance applies irrespective of how those compounds entered the waste stream.

Australian context: IChEMS, PFAS NEMP, and the therapeutic goods sector

Australia’s contaminated land and chemical management frameworks have been progressively tightened over the past decade. The PFAS NEMP, now in its third iteration, provides national guidance on assessment, investigation levels, and remediation approaches for PFAS-affected sites.

References and related sources

• Primary source: www.tga.gov.au
• PFAS National Environmental Management Plan (NEMP)
• NEPM Assessment of Site Contamination

How iEnvi can help

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This is an iEnvi Machete news summary. Prepared by iEnvi to summarise the source article for contaminated land, groundwater, remediation, approvals and site risk professionals.

Published: 20 Apr 2026

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