The Therapeutic Goods Administration (TGA) has initiated a public consultation on proposed amendments to the Poisons Standard, aimed at enhancing the regulation of certain sunscreen ingredients and related substances. These proposals have been developed to ensure the safe use of chemicals in therapeutic and cosmetic sunscreens, while maintaining consistency across Australian jurisdictions.
The consultation focuses on three substances:
Homosalate
Oxybenzone
Benzophenone (as an impurity/degradant)
These substances are being considered for rescheduling based on emerging scientific evidence and international regulatory trends. The proposed amendments include options for:
restrictions on the maximum concentration of these substances in sunscreens
restrictions based on application to parts of the body
restrictions based on age of the consumer
The proposed amendments have been referred to the Joint Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) at a meeting to be held on 17 September 2025. Following the public consultation and subsequent recommendations and advice from the Joint ACMS-ACCS, the delegate of the Secretary of the Department of Health, Disability and Ageing will make an interim decision. The Interim Decision that may incorporate one or more of the options (with modification) for each substance. Neither the TGA nor the Delegate have formed a view at this time as to which options should be implemented or are preferred.
The consultation was open to public comment until 12 August 2025, and all submissions will inform the delegate's interim decision.
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