Additional public consultation on the scheduling of ethylene oxide, propylene oxide and epichlorohydrin

Overview

Proposed scheduling amendments for ethylene oxide, propylene oxide and epichlorohydrin

This consultation is in relation to a proposal to amend the current scheduling of ethylene oxide, propylene oxide and epichlorohydrin. All the three substances are listed is the current Poisons Standard as Dangerous Poisons (Schedule 7) without any exception.  

The applicant proposed that preparations containing less than 0.002% (20 ppm) of ethylene oxide, propylene oxide and epichlorohydrin be exempted from the Schedule 7 entries for these substances.  

This proposal was referred to joint advisory committees on medicines and chemicals scheduling and consulted with the public. In November 2024, the joint advisory committees considered the application and submissions from the public consultation on the proposed changes. In March 2025, the Delegate made an interim decision to not amend the Poisons Standard and a public consultation on the interim decisions were undertaken.  

The Delegate has considered the available evidence and the public submissions on the interim decision and noted the carcinogenic and genotoxic potential of these chemicals. The Delegate remains concerned about the limited evidence to support a specific concentration to exempt from scheduling, preparations for human use that contain ethylene oxide, propylene oxide and epichlorohydrin that would be of low risk to public health. This consultation is seeking further information on the following: 

1. the concentrations of ethylene oxide, propylene oxide and epichlorohydrin present in products such as consumers goods and personal care products, and industrial hygiene products.

2. the current level of detection of ethylene oxide, propylene oxide and epichlorohydrin in end use products, including information on methods of detection and validation, if any.

Related documents 

• Public notice of interim decisions on proposed amendments to the Poisons Standard - ACMS#46, ACCS#40, Joint ACMS-ACCS#38 - November 2024
• Published responses - Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS November 2024
• Consultation: Proposed amendments to the Poisons Standard – ACMS #46 and Joint ACMS-ACCS #38 meetings, November 2024
• Published responses - Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, November 2024

Why your views matter

Why we are consulting  

When a scheduling application or proposal is made, they are considered by the person to whom the Secretary of the Department of Health, Disability and Ageing has delegated decision making responsibility (the Delegate). The Delegate may seek advice from the expert advisory committees of medicines and chemicals scheduling. The referral process to the advisory committees includes two opportunities for public consultation: one at the pre-meeting stage and one in response to the delegate’s interim decision. Further consultation can be undertaken prior to the making of a final decision.  

What will happen  

Any public submissions received are considered by the Delegate along with advice from the Advisory Committees before they make a final decision.   

Public submissions are published on the TGA website – see the section on Privacy and your personal information in this consultation.