[Australia] Proposed Changes to Poison Standard

On September 18, 2025, Australia’s Therapeutic Goods Administration (TGA) proposed to change hydroquinone restrictions, by removal of the Schedule 2 entry for hydroquinone.

The changes mean cosmetics with hydroquinone could be prescription-only drugs regulated by TGA, unless they are falling into exemptions from Schedule 4 (hair preparations up to 0.3% Hydroquinone, and nail preparations up to 0.02% hydroquinone).

Products with over 10% Hydroquinone will have to be labelled as poisons.

This proposal would align Australian regulations with the EU and US for skin lightening preparations

For more information on the proposed changes, visit: Consultation: Proposed amendments to the Poisons Standard – ACCS, ACMS and Joint ACMS-ACCS meetings – November 2025 | Therapeutic Goods Administration (TGA)

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