On May 29, 2026, the Therapeutic Goods Administration (TGA) under the Australian Department of Health, Disability and Ageing launched a public consultation on proposed amendments to the Poisons Standard regarding the scheduling of salicylic acid (CAS No. 69-72-7). The proposals are detailed in the Public Notice of July 2026.
The consultation follows an evaluation by the Australian Industrial Chemicals Introduction Scheme (AICIS), which identified irreversible eye damage as a primary health risk associated with high concentrations of salicylic acid in dermal cosmetic products. Two options have been proposed to tighten scheduling and labeling requirements for salicylic acid in cosmetics. Stakeholders are invited to submit feedback by June 30, 2026. CIRS Group has summarized the core content of the proposals and compliance recommendations below.
Background
Salicylic acid and its salts are widely used in cosmetic products as denaturants, hair and skin conditioning agents, exfoliants, preservatives, or biocides. Salicylic acid is also used in therapeutic preparations for the treatment of skin age spots, solar keratosis, psoriasis, warts, corns, calluses, and fungal skin infections.
Under the current Poisons Standard in Australia, salicylic acid for dermal use is classified as a Pharmacist only medicine (Schedule 3), except in preparations containing 40% or less salicylic acid. This means that dermal cosmetic products — including at-home chemical peels containing up to 30% salicylic acid — are currently unscheduled and are not required to carry any safety warnings or first aid instructions.
AICIS conducted an evaluation of salicylic acid and its salts and concluded that high concentrations of salicylic acid pose a primary health risk of irreversible eye damage. Cosmetic chemical peels were identified as presenting the greatest risk, as they can contain up to 30% salicylic acid yet fall outside any scheduling controls. Rinse-off cosmetics containing up to 5% salicylic acid also pose a slight risk of eye irritation. The Evaluation Statement recommended that the scheduling of salicylic acid be amended, including the introduction of first aid instructions and safety directions pertaining to eye exposure.
Based on these findings, the Department of Health, Disability and Ageing has referred the proposed amendments to the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #44) for consideration.
Proposed Amendments
TGA has put forward two alternative options for amending the scheduling of salicylic acid. Stakeholders may provide feedback on either or both options. The proposals under consultation are detailed in the Public Notice of July 2026.
Option 1: Creation of a Schedule 6 (Poison) Entry for Dermal Cosmetic Preparations
Option 1 proposes creating a new Schedule 6 entry for dermal cosmetic preparations containing more than 5% salicylic acid. At the same time, the existing Schedule 3 entry would be narrowed to apply only to "dermal therapeutic use" rather than "dermal use" generally. Preparations captured under Schedule 6 would require first aid instructions (Appendix E), warning statements, and general safety directions (Appendix F) pertaining to the risk of eye exposure.
Specific amendments include:
- Schedule 3 – Amend entry: SALICYLIC ACID in preparations for dermal therapeutic use except in preparations containing 40% or less of salicylic acid.
- Schedule 6 – New entry: SALICYLIC ACID in preparations for dermal cosmetic use except in preparations containing 5% or less of salicylic acid.
- Appendix E (First aid instructions): If in eyes, hold eyelids apart and flush continuously with running water for at least 15 minutes; if swallowed, do NOT induce vomiting; contact a Poisons Information Centre.
- Appendix F (Warning statements and safety directions): "Will irritate eyes" (warning statement) and "Avoid contact with eyes" (safety direction).
Option 2: Amending the Existing Schedule 3 Entry with Additional Exemption Conditions
Option 2 does not create a new Schedule entry. Instead, it amends the existing Schedule 3 entry to impose labeling requirements on dermal cosmetic preparations containing 5% or less salicylic acid as a condition for exemption. Dermal cosmetics containing more than 5% salicylic acid would be classified as Schedule 3 (Pharmacist only) preparations. All Schedule 3 preparations would also require first aid instructions and warning statements as in Option 1.
Specific amendments include:
- Schedule 3 – Amend entry: SALICYLIC ACID in preparations for dermal use except: (i) in preparations containing 40% or less of salicylic acid for dermal therapeutic use; or (ii) in preparations containing 5% or less of salicylic acid for dermal cosmetic use when labelled with "will irritate eyes" and "avoid contact with eyes".
- Appendix E and Appendix F requirements are identical to those under Option 1.
Comparison with Glycolic Acid
The AICIS Evaluation Statement noted that glycolic acid presents similar toxicity risks and cosmetic use profiles to salicylic acid. Glycolic acid is already regulated under Schedule 6 of the Poisons Standard at concentrations above 5% (or above 20% if pH is 3.5 or greater), with corresponding first aid instructions, warning statements, and safety directions addressing eye damage risks. The current proposals for salicylic acid draw on this existing regulatory precedent.
International Regulatory Comparison
The Global Cosmetic Ingredient Regulatory Database-Global CosIng, independently developed by CIRS Group indicates that:
In EU, salicylic acid is listed in Annex III (list of substances restricted in cosmetic products) and Annex V (list of preservatives permitted in cosmetic products) of the EU Cosmetics Regulation (EC) No 1223/2009. Based on potential endocrine-disrupting risks, the EU has set the maximum permitted concentration at 0.5% when used in body lotions, eye shadow, mascara, eyeliner, lipstick, and deodorant products, along with additional restrictions including that it shall not be used in products that may pose an inhalation risk to the end user.
In China, salicylic acid is listed in Table 3 (restricted ingredients) of the Safety and Technical Standards for Cosmetics (STSC), with a maximum permitted concentration of 2.0% for leave-on products and rinse-off skin products, and 3.0% for rinse-off hair products. It shall not be used in products for children under three years of age, except shampoos.
In September 2025, China's NIFDC released a draft revision for public comment, proposing to adjust the maximum permitted concentration for leave-on products and rinse-off skin products from 2.0% to: 2.0% for products other than body lotions, eye shadow, mascara, eyeliner, lipstick, and deodorant products; and 0.5% for body lotions, eye shadow, mascara, eyeliner, lipstick, and deodorant products. The additional restrictions would be updated to: "Not to be used in products for children under three years of age; not to be used in products that may pose an inhalation risk." Once finalized, these requirements will be largely aligned with the EU.
CIRS Reminder
This consultation proposes significant changes to the scheduling of salicylic acid in Australian cosmetics. Cosmetics enterprises exporting to Australia should pay attention to the following:
1. Review product formulations. Companies should check whether their dermal cosmetic products exported to Australia (particularly chemical peels, exfoliants, and anti-acne products) contain salicylic acid or its salts at concentrations exceeding 5%. Under either option, such products would be brought within scheduling controls.
2. Prepare for labeling changes. Dermal cosmetics containing 5% or less salicylic acid would require new warning statements ("will irritate eyes") and safety directions ("avoid contact with eyes"), as well as first aid instructions. Companies should begin preparing updated labeling materials in advance.
3. Assess product compliance strategy. For products containing more than 5% salicylic acid, companies must evaluate whether to reformulate to reduce the concentration or accept the applicable scheduling requirements — Schedule 6 (Option 1) or Schedule 3 / Pharmacist only (Option 2).
4. Monitor further developments. After the consultation closes, TGA will publish interim decisions and invite further comment. Companies should track the final outcome of the scheduling review and adjust their compliance strategies accordingly.
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