TGA Reopens Consultation on Poisons Standard Scheduling of Ethylene Oxide, Propylene Oxide and Epichlorohydrin: Comments Due 26 October 2026

TGA Reopens Consultation on Poisons Standard Scheduling of Ethylene Oxide, Propylene Oxide and Epichlorohydrin: Comments Due 26 October 2026

On 17 August 2026, the Australian Therapeutic Goods Administration (TGA) opened a supplementary public consultation on proposed amendments to the scheduling of ethylene oxide, propylene oxide and epichlorohydrin under the Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons). The consultation closes on 26 October 2026. TGA states on the consultation platform that the scheduling proposals for these three substances have already been the subject of one round of public consultation, and that this round seeks further information on key outstanding factual questions.

Current Scheduling and the Boundaries of the Proposal

According to the consultation page, all three substances are currently listed in Schedule 7 (Dangerous Poisons) of the Poisons Standard, with no exceptions set. The applicant's proposal is to exempt preparations containing less than 0.002% (i.e. 20 ppm) of ethylene oxide, propylene oxide or epichlorohydrin from the corresponding Schedule 7 entries.

It should be noted that this proposal has not been adopted, and the current scheduling remains unamended.

Where the Matter Currently Stands

The consultation page sets out the timeline: in November 2024, the joint advisory committees (for medicines and chemicals scheduling) considered the application and public submissions; in March 2025, the Delegate of the Minister made an interim decision not to amend the Poisons Standard, and a separate public consultation was conducted on that interim decision. The documents state that, after considering the available evidence and public submissions, the Delegate noted the carcinogenic and genotoxic potential of the three substances and expressed concern about the insufficiency of evidence supporting a specific exemption concentration, particularly for preparations intended for human use.

What This Round of Consultation Seeks to Collect

The supplementary consultation expressly lists two categories of information:

• the concentrations of ethylene oxide, propylene oxide and epichlorohydrin in products such as consumer goods, personal care products and industrial hygiene products; and
• current detection levels for these three substances in finished products, including the test methods available and their validation status.

In other words, this round does not directly seek positions on whether an exemption should be granted; it first seeks to establish the factual basis of how high actual concentrations are and whether they can be detected. The page also notes that earlier public submissions on the interim decision have been published.

Relevance to Medical Devices and IVDs

The audience listed on the consultation page expressly includes Medical Devices & IVDs. Ethylene oxide is one of the processes widely used for medical device sterilisation, so the concentration and detectability of ethylene oxide in finished products are themselves practical issues for the device supply chain.

The boundaries should nevertheless be stated clearly: this round of consultation concerns the factual basis underpinning the Poisons Standard scheduling, and is not a dedicated new rule on residue limits for medical device sterilisation. The consultation page also does not provide a device-specific compliance deadline or limit value.

What Happens Next Procedurally

According to the page, submissions must be lodged through the TGA consultation hub, and public submissions will be published. The submissions received will be considered by the Delegate of the Minister together with the advice of the advisory committees, after which a final decision will be made. Until a final decision is made, the scheduling of these three substances remains unchanged; this round of consultation does not itself alter any existing requirements or create any new compliance obligations.

Sources and Applicability

Sources:

• TGA consultation notice, "Additional public consultation on amending the Poisons Standard regarding ethylene oxide, propylene oxide and epichlorohydrin," consultation period 17 August 2026 to 26 October 2026. https://www.tga.gov.au/news/consultations/additional-public-consultation-amending-poisons-standard-regarding-ethylene-oxide-propylene-oxide-and-epichlorohydrin
• TGA Consultation Hub, the same consultation page, containing the proposal content, timeline and the two categories of consultation questions. https://consultations.tga.gov.au/tga/scheduling-eo-po-ech
• TGA public notice of interim decisions (PDF), November 2024, concerning meetings ACMS#46, ACCS#40 and Joint ACMS-ACCS#38. https://www.tga.gov.au/sites/default/files/2025-03/public-notice-of-interim-decisions-acms46_accs40joint-acms-accs38-november-2024.pdf

Scope of verification and access date: For this review, the TGA consultation notice page, the full text of the consultation on the TGA consultation platform (including the proposal content, timeline, consultation questions, audience and process description) and the file name of the related TGA interim decision notice were checked. The access date was 13 October 2026. The final decision text of the consultation and any subsequent official updates are governed by the original TGA publications; this article does not reproduce the related historical public submissions item by item.

Applicability statement: This article is an interpretation of publicly available Australian TGA regulatory information and does not constitute a conclusion or commitment in respect of any specific product, company or registration application. It describes the public consultation status of amendments to the Poisons Standard scheduling; the current scheduling of the three substances and any exemption conclusions are governed by the official texts. Scheduling and limit requirements for comparable substances differ between regulatory jurisdictions, and for specific products the most recent notices of the local regulatory authority should be relied upon. Information may change with subsequent official updates.

AIMEILI Regulatory Interpretation

The central point for industry is that no regulatory change has taken effect. Ethylene oxide, propylene oxide and epichlorohydrin remain Schedule 7 entries under the Poisons Standard with no exceptions, and the March 2025 interim decision was not to amend the Standard. The applicant's proposed exemption for preparations below 0.002% (20 ppm) remains a proposal only. Manufacturers should therefore not treat a 20 ppm threshold as an applicable exemption, and should not adjust labelling, storage, handling or supply arrangements on the assumption that a de minimis carve-out will be introduced.

The design of this consultation round is also instructive. Rather than asking stakeholders whether an exemption is appropriate, TGA is seeking the factual record: measured concentrations in consumer, personal care and industrial hygiene products, and current detection capability and method validation for the three substances in finished products. This mirrors the Delegate's earlier concern that the evidence did not support a specific exemption concentration, particularly for preparations for human use. For ethylene oxide in particular, the practical question of whether residual levels in terminally sterilised devices can be reliably detected and quantified at very low concentrations is directly relevant to whether any numerical exemption could ever be substantiated.

Finally, the reference point matters. The consultation audience expressly includes Medical Devices & IVDs, which signals that device-sector data are relevant to the scheduling assessment. It does not, however, create a device-specific residue limit, a new sterilisation requirement or a compliance deadline. The applicable residue and sterilisation requirements for devices remain those set out in the existing TGA regulatory framework and, where relevant, in recognised standards and international pharmacopoeial requirements. Stakeholders who submit comments through the TGA consultation hub should be aware that submissions are published.

Business Impact

• No immediate change to obligations: Current scheduling, handling and classification requirements for ethylene oxide, propylene oxide and epichlorohydrin are unchanged. No action is required on the basis of this consultation alone.
• Ethylene oxide sterilisation supply chains: Contract sterilisers, device manufacturers using EO sterilisation and their logistics partners should continue to monitor the consultation, because the outcome could eventually influence how low-concentration EO-containing preparations are classified in Australia, with knock-on effects for handling, transport and storage controls.
• Testing and analytical capability: Companies that already hold residue or detection data for these substances in finished products, including validated methods and limits of detection or quantification, are well placed to contribute meaningful evidence. Such data may also support broader residue and toxicological risk documentation.
• Regulatory monitoring: A final decision is expected only after this consultation closes and the Delegate considers submissions together with committee advice. Regulatory affairs teams should track the outcome and assess at that point whether any change to internal procedures, supplier controls or documentation is warranted.
• Jurisdictional divergence: Requirements for these substances differ between jurisdictions. Companies operating across multiple markets should maintain jurisdiction-specific assessments rather than applying a single global assumption.