Australia's Therapeutic Goods Administration (TGA) opened a public consultation on September 11, 2026 on proposed amendments to the Poisons Standard for 4-methylbenzylidene camphor (4-MBC), a UV filter used in sunscreens and cosmetics. The Delegate and two private applicants have put forward three scheduling options, ranging from new concentration limits to a complete prohibition. Submissions close on October 12, 2026, ahead of the joint Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) meeting #45 in November 2026.
4-MBC is not currently listed in the Poisons Standard, so any of the three options would create a new scheduling obligation for products sold in Australia. Option 3, proposed jointly by both applicants, would place 4-MBC in Schedule 10, prohibiting it in all therapeutic goods and cosmetic products outright. The full proposals are set out on the official TGA consultation page.
What are the three scheduling options on the table?
The consultation presents one prohibition and two concentration-limit models. Option 1, proposed by the Delegate, sets a single consistent threshold: 4-MBC in therapeutic sunscreens and cosmetic preparations is scheduled except where the product contains 0.39% or less of 4-MBC.
Option 2, also from the Delegate, splits the exemption by product type, application site and user age. Therapeutic sunscreens for the face and hands are exempt up to 0.95% 4-MBC, or up to 3.8% when intended for persons aged 18 years and over, while cosmetic preparations for the face and hands are exempt up to 3.3%. Option 3, proposed by both applicants, places 4-MBC in Schedule 10, banning it in all therapeutic goods and cosmetic products with no concentration exemption.
| Option | Proposed by | Effect | Exemption threshold |
|---|---|---|---|
| Option 1 | Delegate | Schedule 5 | 0.39% or less (all products) |
| Option 2 | Delegate | Schedule 5 | 0.95% / 3.8% sunscreens, 3.3% cosmetics |
| Option 3 | Both applicants | Schedule 10 (prohibition) | None |
Who must act on the 4-MBC consultation?
The proposal hits sunscreen and cosmetic manufacturers and importers selling into Australia with 4-MBC in their product lines. The exposed actors span multinationals that formulate globally and local brands that source finished goods: L'Oreal, Beiersdorf (Nivea), Johnson & Johnson and Unilever on the international side, alongside Australian names such as Cancer Council sunscreens, Bondi Sands and Ego Pharmaceuticals.
A scheduling change ripples across both layers of Australia's sunscreen regime. Therapeutic sunscreens, which carry an SPF claim, are regulated by the TGA under the Therapeutic Goods Act 1989 and listed on the Australian Register of Therapeutic Goods (ARTG), while cosmetic sunscreens fall under the Australian Consumer Law. A Schedule 5 or Schedule 10 entry applies to 4-MBC whenever it is used, regardless of whether the product is therapeutic or cosmetic.
What should manufacturers and importers do before October 12, 2026?
First, audit product lines for 4-MBC. The review should cover both primary sunscreens and secondary SPF-bearing cosmetics such as moisturizers, tinted products and lip preparations. Identify which of the three options each formulation could survive: a product above 0.39% fails Option 1's blanket exemption, and any 4-MBC at all fails Option 3.
Second, prepare and lodge a public submission by close of business on October 12, 2026. Submissions go to the TGA scheduling team via the consultation portal and are considered by the Delegate and the advisory committees before an interim decision. If no pre-meeting submissions are received, the Delegate may proceed directly to a final decision, so silence carries its own risk.
Third, start reformulation planning now. Even under the limit options, moving away from 4-MBC toward mineral filters such as zinc oxide, or alternative organic filters, de-risks the portfolio against a later tightening or an eventual prohibition. The EU already removed 4-MBC from the permitted UV-filter list of Regulation (EC) 1223/2009 and listed it as prohibited, so Australia is moving toward established global precedent rather than breaking new ground.
What happens after the consultation closes?
The ACMS and ACCS advise the Delegate at the November 2026 joint meeting. The Delegate then weighs that advice with the public submissions and may issue an interim decision, which triggers a second round of public consultation before a final decision. A final scheduling amendment would be made by legislative instrument under section 52D of the Therapeutic Goods Act 1989 and registered on the Federal Register of Legislation, taking effect from its commencement date. The detailed proposals and the submission portal are in the pre-meeting public notice (PDF).
Continuous, per-jurisdiction real-time monitoring surfaces this kind of scheduling change the moment a regulator publishes it, before the November meeting converts a proposal into a binding instrument.
Subscribe to the free newsletter
For compliance teams the checklist is tight: confirm whether your SKUs contain 4-MBC, map each formulation against the three options, file a submission by October 12, and brief the regulatory affairs and formulation teams on the November ACMS-ACCS outcome. Obsidian follows this consultation through to the registered instrument.
