On April 3, 2024, the Therapeutic Goods Administration (TGA) of Australia initiated a consultation on interim decisions concerning 14 substances listed in the Poisons Standard. The Poisons Standard categorizes substances used in medicines, cosmetics, etc. into different schedules to regulate their availability to the public based on the assessment of their benefits and risks.
The consultation addresses an initial proposed amendment to the Poisons Standard, with the interim decisions serving as adjustments to the previous amendment.
Three of the substances involved in this consultation—methenamine, adrenaline, and benzoic acid—can be used in cosmetics. While the provisional decisions do not directly modify the cosmetic uses of the substances, it can be beneficial for relevant manufacturers to stay informed about the regulatory updates regarding these substances.
Methenamine in cosmetic preparations, except in preparations containing 0.15% or less of methenamine is included in Schedule 5—Caution, while the interim decisions newly requires that methenamine, if used in preparations for therapeutic use, should be included in Schedule 3—Pharmacist only medicines.
Adrenaline is considered with potential risks if in appropriately used in cosmetic procedures. The substance’s entries in Schedule 3 and Schedule 4 are respectively amended as follows:
Amending entry in Schedule 3—Pharmacist only medicines:
Adrenaline in preparations containing 1% or less of adrenaline except in preparations that are not for injection containing 0.02% or less of adrenaline unless packed and labelled for injection.
Amending entry in Schedule 4—Prescription only medicines and prescription animal remedies:
Adrenaline inexcept:
(a) when included in Schedule 3 topical preparations for the treatment of wounds in humans; or
(b) in all other preparations containing 0.02% or less of adrenaline unless packed and labelled for injectionexcept when included in or expressly excluded from Schedule 3.
Benzoic acid is widely used in cosmetics, foods, medicines, and agricultural products. The substance is newly added to Schedule 5—Caution with the condition that it (excluding its salts and derivative) is used in preparations for agricultural use except preparations containing less than 1% of benzoic acid.
If you have any advice during the consultation period, which will end on April 17, 2024, please submit them to https://consultations.tga.gov.au/tga/scheduling-interim-decision-november-2023/consultation/subpage.2020-08-24.4118714205/
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
