Public consultation on proposed amendments to the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC) – Joint ACMS-ACCS #45, November 2026

Overview

This consultation is for a proposal to amend the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC). The Delegate and two private applicants have proposed 3 different options to schedule 4-MBC which is not listed in the current Poisons Standard.

Option 1 (proposed by the Delegate)

This option treats all products consistently and provides one consistent upper limit for 4-MBC for exempting cosmetics and therapeutic sunscreens from the Poisons Standard.

Schedule 5 – New Entry

4-METHYLBENZYLIDENE CAMPHOR in therapeutic sunscreens and cosmetic preparations except in preparations containing 0.39% or less of 4-methylbenzylidene camphor 

Option 2 (proposed by the Delegate)

This option provides different upper limits for 4-MBC for exempting cosmetics and therapeutic sunscreens from the Poisons Standard, based on age, sunscreen type and application site.

Schedule 5 – New Entry

4-METHYLBENZYLIDENE CAMPHOR in therapeutic sunscreens and cosmetic preparations except:

1. in therapeutic sunscreens for application to the face and hands containing 0.95% or less of 4-methylbenzylidene camphor; or
2. in therapeutic sunscreens for application to the face and hands containing (i) 3.8% or less of 4-methylbenzylidene camphor; and for use by persons (ii) aged 18 years and over; or

3. in cosmetic preparations for application to the face and hands containing 3.3% or less of 4-methylbenzylidene camphor 

Option 3 (proposed by both the applicants)

This option prohibits the use of 4-MBC in all therapeutic goods or cosmetic products.

Schedule 10 – New Entry 

4-METHYLBENZYLIDENE CAMPHOR when used in therapeutic goods or cosmetic products.  

The Delegate is seeking public comments on the proposed amendments for further consideration at the joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) in November 2026.

The proposals under consultation are detailed in the Public Notice for the November 2026 meeting.

• Pre-meeting public notice - 4-MBC - November 2026 (PDF)
• Pre-meeting public notice - 4-MBC - November 2026 (Word)

The closing date for this consultation is close of business 12 October 2026. All submissions received by the deadline, including votes and comments will be considered by the Delegate before making an interim decision.

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 to (the Delegate). The Delegate may seek advice from the the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS). Where a proposal is referred to an advisory committee, the Delegate must invite public submissions on the proposal. The referral process to the Advisory Committees usually includes two opportunities for public consultation; one at the pre-meeting stage and one in response to the Delegate’s interim decision. 

What will happen 

This is a pre-meeting consultation. Any public submissions received are considered by the Advisory Committees before they provide advice or a recommendation to the TGA Delegate. The Delegate will consider the Advisory Committees advice and the public submissions before making an interim decision. If no pre-meeting public submissions are received the Delegate may proceed directly to make a final decision. If the Delegate makes an interim decision, there will be a further call for public submissions, which the Delegate will take into account before making a final decision.

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