The TGA is consulting on scheduling 4-MBC in sunscreens. Options range from a 0.39% cut-off to outright prohibition, and Schedule 5 would rule it out of Listed medicines. Submissions close 12 October 2026.

Opened 11 September. Closes 12 October.

The TGA has opened a pre-meeting public consultation on amending the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC), a UVB filter currently permitted in Australia at a maximum concentration of 4% in topical therapeutic sunscreens and cosmetic preparations.

Submissions close close of business, 12 October 2026, ahead of Joint ACMS-ACCS #45 in November.

If 4-MBC is anywhere in your range, the next four weeks matter.

Three options, and a very wide gap between them

4-MBC is not currently scheduled in the Poisons Standard. Every option therefore creates an entry where none exists.

Option 1 — Delegate. A new Schedule 5 entry for 4-MBC in therapeutic sunscreens and cosmetic preparations, except preparations containing 0.39% or less. The Safety Review concluded 4-MBC can be deemed low-risk at up to 0.39% in general therapeutic sunscreens for daily use. One consistent cut-off, all products treated alike.

Option 2 — Delegate. A new Schedule 5 entry with exemptions tiered by product type, application site and age:

  • therapeutic sunscreens for face and hands at 0.95% or less — reflecting daily use by the whole family
  • therapeutic sunscreens for face and hands at 3.8% or less, for persons aged 18 and over
  • cosmetic preparations for face and hands at 3.3% or less

Option 3 — two private applicants. A new Schedule 10 entry prohibiting 4-MBC in therapeutic goods and cosmetic products.

The applicants argue 4-MBC is a confirmed endocrine disruptor affecting thyroid and oestrogen systems, that its genotoxic potential cannot be excluded, and that because no safe threshold can be established, concentration limits and warning labels cannot adequately address the risk — particularly for a product used unsupervised by children, pregnant women and people with thyroid conditions.

Importantly: the TGA and the Delegate have expressly not formed a view on which option is preferred. This is genuinely open.

The consequence the media release doesn't spell out

Here is the detail sponsors need to register. A Schedule 5 entry does two things: it requires a CAUTION signal word on the main label, and — critically — substances covered by a Schedule 5 entry cannot be used in Listed medicines.

Therapeutic sunscreens are Listed medicines. So under Option 1 or Option 2, a therapeutic sunscreen that falls outside the relevant exemption doesn't simply acquire a warning label. It cannot remain a Listed medicine at all.

That reframes the decision. This isn't a labelling question with a reformulation option attached; for products above the cut-off it is a reformulate-or-exit question. Given Option 1's threshold is 0.39% against a current ceiling of 4% — roughly a tenfold reduction — that will capture a meaningful number of formulations.

Why Australia may land stricter than elsewhere

The review followed the TGA's Australian Sunscreen Exposure Model, developed in 2024 and adopted in January 2025. Its central finding is straightforward: Australians apply sunscreen more often, and in greater quantity, than the populations underpinning international models. Higher exposure, lower acceptable concentration.

Internationally the picture is already moving. The EU has phased 4-MBC out — it could not be placed on the market from 1 May 2025, nor sold from 1 May 2026, and it has been removed from Annex VI of the Cosmetics Regulation. The UK has barred new products since 15 July 2026, with sale prohibited from 15 January 2027. The US FDA determined in 2015 that it was not "generally recognised as safe and effective," on the basis of insufficient data rather than proven risk. Health Canada still permits up to 4%.

Australia is deciding where it sits on that spectrum.

Don't overlook the cosmetic side

Worth remembering that cosmetic sunscreens are excluded goods regulated through AICIS, not the TGA — lip products, tinted bases and foundations, moisturising and sunbathing skin care products.

But the Poisons Standard applies across both. Options 1 and 2 each reach cosmetic preparations as well as therapeutic sunscreens, so a business with products either side of the therapeutic boundary has exposure on both.

The public health message is unchanged

Stated plainly, because clients and consumers will ask: the TGA is not proposing any change to sunscreen use, and no warnings, bans or recalls of products on the market. Its advice remains that Australians should keep using sunscreen alongside the other SunSmart measures — shade, hats, protective clothing and eyewear.

Australia has the highest rates of skin cancer in the world. This is a precautionary review of one ingredient, and brands should be careful that it isn't reported internally, or to customers, as anything more.

What sponsors should do in the next four weeks

  • Identify every product containing 4-MBC and its concentration — therapeutic and cosmetic.
  • Model all three options against your range. Under Option 1, are you above 0.39%? Under Option 2, do your products fit the face-and-hands, age and product-type carve-outs? Under Option 3, what is the full exposure?
  • Check your Listed medicine status. If a therapeutic sunscreen sits outside the exemptions, Schedule 5 means it cannot remain Listed.
  • Scope reformulation and re-testing lead times — SPF and broad-spectrum testing is neither quick nor cheap, and it collides with the AS/NZS 2604:2021 transition already underway.
  • Make a submission. Pre-meeting submissions go to the Committees before they advise the Delegate — the point of maximum influence. If no pre-meeting submissions are received, the Delegate may proceed straight to a final decision.
  • Handle confidentiality properly. Submissions are published on the TGA website. Commercially sensitive material must be supplied under separate cover, clearly marked "IN CONFIDENCE," with reasons given.
  • Diarise round two. An interim decision triggers a further call for submissions before the final decision.

How Engel Hellyer & Partners can help

Sunscreen regulation is among our deepest specialisms, and scheduling submissions are routine work for us. We can model each option against your formulations, quantify the reformulation, re-testing and Listed medicine exposure, and prepare a submission that argues your position on the evidence — drafted in the knowledge it will be published.

Between us our directors bring around a century of combined regulatory experience in this area, including participation in the Australian standards work that underpins sunscreen regulation.

With submissions closing 12 October 2026, there is time to do this properly — but not much of it. If you have 4-MBC in your range, we're happy to take a look.

This article is general information only and does not constitute regulatory advice for any specific product. Consultation proposals may change; confirm the current

position before acting.

Further reading

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Primary sources from the Therapeutic Goods Administration:

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Written by 
Dr Renée Badenhop
Renee received a Bachelor of Science at the University of Sydney and a Bachelor of Science (Honours) at Macquarie University and in 1997 she was awarded a PhD (Medicine) at the University of NSW. In 2005 she completed a Master’s Degree in Industrial Property at the University of Technology. Renee has been Director at Engel Hellyer & Partners since 2013.