TGA consultation at a glance

(Joint ACMS‑ACCS #41 – September 2025)

On 8 July 2025 the Therapeutic Goods Administration (TGA) published a 19‑page pre‑meeting notice proposing new Schedule 5 (CAUTION) listings for three petro‑chemical sunscreen ingredients: homosalate, oxybenzone (benzophenone‑3) and benzophenone. The proposals will be considered by the Joint Advisory Committee on Medicines and Chemicals Scheduling (ACMS‑ACCS) at its September 2025 meeting. Public submissions close 12 August 2025.

1. Why the TGA is acting now

• Updated exposure science.  The TGA’s Australian Sunscreen Exposure Model (ASEM, adopted January 2025) shows Australians apply sunscreen more frequently and in greater quantities than the assumptions used in many overseas risk assessments.

• International precedent.  The EU have already restricted homosalate and oxybenzone and prohibited benzophenone in cosmetic products from November 2023.

• Regulatory advice.  AICIS evaluation statements (Dec 2024 for homosalate, Jun 2025 for benzophenone) call for Poisons Standard listings to manage long‑term systemic risks.

• Draft TGA Assessment in 2019 Identified that both Homosalate and Oxybenzone pose a serious risk to public health at currently approved concentrations.

  
  

2. Proposed homosalate controls

Option	Exemption conditions	Maximum % allowed	Notes
1 (general)	All preparations	0.28 %	Aligns with TGA safety review “low risk” level for whole‑body use.
2 (site‑specific)	Face & hand therapeutic ≤ 0.68 %  /  Face & hand cosmetic ≤ 4.35 %	Up to 4.35 %	Mirrors AICIS risk evaluation; tighter for therapeutic sunscreens.
3 (adult‑only)	Adults, face & hand use, all products ≤ 2.7 %	2.7 %	Higher limit for adult‑only products.

All other homosalate‑containing products would become Schedule 5 poisons, requiring the word “CAUTION” on the main label and exclusion from Listed (AUST L) medicines.

3. Proposed oxybenzone controls

Option	Exemption conditions	Maximum % allowed	Notes
1 (general)	All preparations	1 %	Whole‑body limit based on TGA risk modelling.
2 (site‑specific)	Therapeutic face & hand ≤ 2.5 %  /  Cosmetic face & hand ≤ 6 %	Up to 6 %	Uses EU cosmetic limits for leave‑on face/lip products.
3 (adult‑only)	Adults, face & hand use, all products ≤ 9.8 %	9.8 %	Highest limit, but adult‑only.

Industry feedback notes oxybenzone is already uncommon in Australian formulas due to “reef safe” positioning.

4. Proposed benzophenone controls

• Schedule 5 listing for benzophenone when used as a fragrance in therapeutic or cosmetic products, or in air‑care items.

• Exemption for sunscreens when benzophenone is present ≤ 0.0383 % (383 ppm) as an impurity or degradation product of octocrylene.

• Air‑care products may contain up to 0.3 % before triggering scheduling, and must bear the safety direction “Use only in well‑ventilated area”.

  
  

5. Regulatory pathway & key dates

Milestone	Date
Consultation opens	8 July 2025
Public submissions due	12 August 2025
ACMS‑ACCS meeting #41	September 2025
Delegate’s interim decision published*	12 August 2025 (placeholder date in notice)

*The notice states 12 August 2025 for interim decisions; this may be updated once committee advice is received.

6. Practical implications

Stakeholder	Likely impact
Manufacturers	Reformulate or withdraw products exceeding new limits; update labels to comply with Schedule 5.
Importers/Retailers	Check inventory for affected SKUs; anticipate transition timelines.
Consumers	Continued encouragement to use sunscreen; may see shift toward mineral (zinc/titanium) formulations that already meet draft limits.
Regulators	Potential follow‑on reviews of 4‑MBC, octocrylene and other chemical filters flagged in TGA’s 7‑ingredient safety review.

7. How to respond

Submissions can be lodged via the TGA consultation hub until close of business 12 August 2025. Commenters should address:

• Which option (if any) should be adopted for each substance.

• Transition periods required for reformulation and labelling.

• Any additional risk‑management measures (e.g., age restrictions, pack warnings).

• Potential unintended consequences for sun‑protection behaviour.

Bottom line

The TGA’s paper signals a major tightening of allowable limits for homosalate, oxybenzone and benzophenone in both therapeutic and cosmetic sunscreens. While no final decision has been made, every option tabled would force significant reformulation of popular chemical sunscreens.