FOI Release: TGA Documents on the Scheduling of Homosalate, Oxybenzone and Octocrylene
- Australian Sunscreen Council
- 17 hours ago
- 6 min read
The Australian Sunscreen Council has obtained ten documents from the Therapeutic Goods Administration under Freedom of Information. We are making them publicly accessible here, as released.
About this release
In July 2026 the Australian Sunscreen Council received ten documents from the Therapeutic Goods Administration (TGA) under the Freedom of Information Act 1982Â (Cth), released under FOI reference 26-3100. They relate to the TGA's consideration of proposed poison-scheduling restrictions on the sunscreen ingredient homosalate, alongside oxybenzone and octocrylene.
Taken together, the documents show that the TGA proposed restrictions on homosalate in July 2025 — including listing it in the Poisons Standard and reducing its permitted concentration in therapeutic sunscreens — and that its own review recorded concerns about endocrine, fertility and developmental risks. They also show that, after industry lobby groups presented to a joint scheduling committee, a decision on homosalate was shelved for further work, even though the TGA's public consultation showed majority support for restricting it. Internal correspondence went as far as to ask "what is the likely net harm?" of the ingredient.
Because these documents have been released to us directly and are not yet published on the TGA's own FOI disclosure log, as the Australian Sunscreen Council is the peak body for Australian Sunscreen, we are making them available here in full, so that industry, researchers, health professionals and the public can read them and reach their own conclusions.
We are publishing the documents exactly as they were released to us, including all redactions made by the TGA, and we have not altered their contents. Our aim is to support transparency and honest public discussion about the regulation of sunscreen ingredients in Australia.
What the documents cover
The proposal. The TGA is considering a new Schedule 5 ("Caution") entry for homosalate, with three possible options that would exempt sunscreens and cosmetics below certain concentrations depending on the product type, where it is applied on the body, and the user's age.
The science. The TGA's nonclinical advice reviews animal toxicity data and pharmacokinetic modelling for homosalate, establishes safety reference points, and recommends that homosalate be listed in the Poisons Standard with restrictions.
Industry lobbying. Accord Australasia — an Australasian industry lobby group that advocates for chemical (petrochemical-derived) UV filters to remain on the market — and a presenter nominated by CHP Australia presented to the joint scheduling committee against restrictions on ingredients their members profit from, at the September 2025 meeting. The documents show the committee subsequently declined to hear further external presentations.
The delay. Internal TGA correspondence shows that, following these industry presentations, a decision on homosalate was shelved for further work — even though the TGA's public consultation showed majority support for restricting homosalate and the TGA's own review recorded endocrine, fertility and developmental risks. The Council considers the delay to be linked to that industry lobbying, and says the documents raise a clear question of whether Australians are being protected according to safety risk or according to industry pushback.
The international context. Background material covers the position of the US Food and Drug Administration and the European market following the EU's restrictions on homosalate.
The documents
Below are the ten documents as released, each with a short plain-English summary. Click to download.
Document 1 — TGA Pre-Meeting Brief on Agenda Papers (Joint ACMS-ACCS #41, 17 September 2025)
The TGA's official pre-meeting brief for the joint scheduling committee. It sets out the Delegate-initiated proposal to create a new Schedule 5 ("Caution") entry for homosalate, the three exemption options under consideration (by concentration, product type, application site and age), and the Delegate's reasons — including that homosalate is used in most Australian sunscreens (more than 169 tonnes a year), is absorbed through the skin, and may have effects relevant to the kidneys, fertility and development.
Document 2 — Industry Presentation: John Staton, SciPharm Pty Ltd (nominated by CHP Australia)
A technical research-and-development and manufacturing presentation to the September committee meeting. It explains how restricting homosalate, oxybenzone and octocrylene would affect sunscreen formulation — why high-SPF, broad-spectrum products rely on multiple UV filters, the role octocrylene plays as a solvent and stabiliser for avobenzone, product testing costs, and the prospect that many water-resistant sunscreens could require reformulation.
Document 3 — Accord Australasia Presentation: "Homosalate and Oxybenzone Scheduling — Impacts on Industry"
A presentation to the committee by Accord Australasia — an Australasian industry lobby group representing personal care and specialty product suppliers — setting out the commercial and supply impacts of the scheduling proposals on the industry, and arguing against restrictions on the affected ingredients.
Document 4 — TGA Email to Accord: External Presentations Declined for November Meeting (4 November 2025)
Correspondence in which the TGA's Medicines Scheduling team advises Accord that, while its September presentation was appreciated, the Committee Chairs decided not to proceed with external presentations at the November meeting because the points raised were considered to be substantially covered by written submissions.
Document 5 — Internal TGA Emails: "Update on Sunscreen" (7 October 2025)
An internal TGA email chain in which a committee member suggests viewing the issue "through a public health lens," notes the alternatives and potential net harm should be weighed, and observes there is "no rush" on the decision. The Scheduling Secretariat agrees to undertake additional work — reviewing the PBK modelling, the Symrise study and the SCCS and SAG-CS findings — and report back in November.
Document 6 — Internal TGA Emails and Research Summary: "Research on Sunscreens" (16 October 2025)
An internal email chain in which the Scheduling Secretariat researches how sunscreens can be formulated without homosalate and how well the substitutes perform. The attached summary reviews newer-generation UV filters (such as Mexoryl 400, TriAsorB and DBT), cites peer-reviewed studies, and examines product availability in the European market following the EU's restrictions on homosalate from 1 July 2025. It also attaches the action items from the September joint committee meeting.
Document 7 — TGA Nonclinical Advice for Homosalate
The TGA's scientific (toxicology) assessment of homosalate. It reviews a combined repeat-dose and reproductive/developmental toxicity study in rats and a published pharmacokinetic (PBPK) model, establishes a no-observed-adverse-effect level (NOAEL) of 120 mg/kg/day for general toxicity — noting a reproductive and developmental NOAEL could not be reliably established — and recommends that homosalate be listed in the Poisons Standard with restrictions on its use.
Document 8 — CMES Input to the Scheduling Agenda Paper (20 October 2025)
An email and attachment from the TGA's Complementary Medicines Evaluation Section (CMES) providing input on the Australian Sunscreen Exposure Model (ASEM) — the exposure-assessment approach preferred following the TGA's 2024 public consultation — including how it aligns with the inputs used by the Scientific Committee on Consumer Safety (SCCS) and supports international harmonisation and consistent risk assessment.
Document 9 — Background Briefing: Homosalate, FDA Status and Meeting Request
Internal background emails covering the international context — including the US FDA's 2020 proposal to classify homosalate as Category III ("not GRASE," pending further data), with no update published since — alongside the Australian timeline and internal correspondence about a meeting request concerning the sunscreen ingredient scheduling issue.
Document 10 — Internal Microsoft Teams Chats (TGA Staff)
Redacted internal Microsoft Teams messages between TGA staff discussing the kidney findings, the choice of NOAEL used in the risk assessment, the broader benefit–risk approach, and media coverage relating to sunscreen formulation and SPF. Substantially redacted.
The Australian Sunscreen Council published this material on the 7th of July 2026 in the interest of transparency. Media enquiries and researchers seeking further information are welcome to contact us using the contact form
Documents obtained from the Therapeutic Goods Administration under the Freedom of Information Act 1982 (Cth), FOI reference 26-3100.
Australian Sunscreen Council
The Australian Sunscreen Council (ASC) is an independent, not-for-profit organisation dedicated to advancing both effective skin cancer prevention and genuine environmental stewardship in Australia.
We bring together sunscreen manufacturers, researchers, dermatologists, and environmental experts to promote science-based sun protection while advocating for innovation in reef-safe and environmentally responsible formulations.
Our position is clear: Australians deserve high-performance sun protection that does not come at the expense of the marine ecosystems we all rely on. As environmental regulators, particularly DCCEEW, increase scrutiny on persistent chemicals across entire classes, we support transparent, evidence-based regulation that closes loopholes and prevents regrettable outcomes.
For more information, to join the Council, or to support our work on regulatory reform, visit australiansunscreencouncil.org.