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Tuesday, August 26, 2025International

Australia notifies proposals for new regulations for 3 UV filters

L'Australie notifie des propositions de nouvelle réglementation pour 3 filtres UV

On 21 August 2025, Australia’s Therapeutic Goods Administration (TGA) launched a consultation on proposed regulatory changes to three UV filters: Homosalate, Oxybenzone (Benzophenone-3) and Benzophenone (as an impurity/degradant). Comments are due by 5 October 2025.

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In its consultation paper, the TGA explains that these three trois substances are being considered for rescheduling based on emerging scientific evidence and international regulatory trends.
For each of these, the proposed amendments to the Poisons Standard include options for:
• restrictions on the maximum concentration in sunscreens
• restrictions based on application to parts of the body
• restrictions based on age of the consumer
The Australian Administration emphasises that, at this stage, no decision has been made on which options will ultimately be implemented.

Homosalate

Substance covered
• Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester (CAS No.118-56-9, EC No.204-260-8, INCI: Homosalate).
• In Australia: currently authorised up to a concentration of 15%.
• In Europe: limited to 7.34% in face products with the exception of propellent spray products, by Regulation (EU) 2022/2195, applicable from 1 January 2025 for products placed on the market and from 1 July 2025 for products made available on the market.

Each option presented proposes a new CAUTION (Schedule 5) entry for homosalate unless the product meets certain exemption criteria.

Option 1: general exemption up to a specific concentration
This option provides one consistent upper limit for exempting all …

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