Azelaic acid, methyl salicylate oils and salicylic acid are all moving through the Poisons Standard. Here's what's decided, what's pending, and the dates that matter.

Scheduling changes rarely arrive all at once — but right now, several are in motion

The Poisons Standard is updated several times a year, and for cosmetic formulators the consequences are practical: a scheduling entry can dictate warning statements, first-aid directions, concentration limits, and in some cases whether a product can be sold as a general retail cosmetic at all.

Three ingredients relevant to cosmetic and personal care formulators are currently moving through that process. Here's where each stands.

1. Azelaic acid — the exemption request wasn't accepted

Industry had proposed that cosmetic preparations containing 10% or less azelaic acid be exempt from Schedule 5, with appropriate eye-exposure warnings.

The interim decision did not accept that proposal. The existing structure is retained: therapeutic dermal preparations in Schedule 2, other therapeutic preparations in Schedule 4, and all other preparations — including cosmetics — in Schedule 5. The finding was that there was insufficient evidence that concentrations at or below 10% are safe for unsupervised general sale.

One change was accepted, and it's a sensible one: the Appendix F safety direction is amended from "Avoid contact with skin" to "Do not use on broken skin." The former was always an awkward instruction for a product designed to be applied to skin.

Proposed implementation: 1 June 2027.

2. Methyl salicylate oils and extracts — cross-references and new warnings

This one covers sweet birch oil, wintergreen oil, birch (Betula lenta) extract and Gaultheria procumbens extract — all typically greater than 90% methyl salicylate.

The decision adds cross-references for each of these four oils and extracts to the existing methyl salicylate index entry, rather than creating separate entries for each. The existing Schedule 4, 5 and 6 methyl salicylate entries are otherwise unchanged.

Two new Appendix F warning statements are added for methyl salicylate liquid in Schedule 5 or 6:

  • "Do not use if pregnant or likely to become pregnant"
  • "Application to skin may increase sensitivity to sunlight"

Proposed implementation: 1 October 2026 — the nearest of the three, and one that will require label changes for affected products.

3. Salicylic acid — a decision still to come

A proposal to amend the entry for dermal cosmetic preparations containing salicylic acid has been through consultation, with two options on the table:

  • Option 1 — create a new Schedule 6 entry for dermal cosmetic preparations above 5% salicylic acid
  • Option 2 — amend the existing Schedule 3 entry so preparations at 5% or less are exempt, provided they carry eye-exposure warning labels

Under both options, preparations above 5% would require Appendix E first-aid instructions and Appendix F eye-exposure warnings.

Salicylic acid is widely used in exfoliants, acne treatments and cleansers, so the outcome will matter to a lot of ranges. The decision is pending — worth watching.

What this means practically

The pattern across all three is the same: more warning statements, and limits that are being clarified rather than relaxed. For formulators, that translates into label and artwork work, and in some cases a decision about whether to reformulate below a threshold rather than take on a schedule entry.

The nearest date — 1 October 2026 for the methyl salicylate changes — is close enough that affected products should already be in the artwork queue.

Who should check their range

  • Anyone using azelaic acid in cosmetic preparations, particularly at or near 10%
  • Products formulated with wintergreen, sweet birch, Betula lenta or Gaultheria procumbens oils or extracts
  • Salicylic acid products around the 5% mark, where the pending decision could be determinative

How Engel Hellyer & Partners can help

Screening formulations against the Poisons Standard, tracking scheduling changes, and translating an entry into the actual warning statements and label copy required is routine work for us — and one of the areas where a small oversight causes a disproportionate amount of trouble.

If you'd like your range checked against these changes while there's still time to act, we're happy to take a look.

This article is general information only and does not constitute regulatory advice for any specific product. Interim decisions may change before finalisation and implementation dates can shift; confirm the current position before acting.

Further reading

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Written by 
Dr Renée Badenhop
Renee received a Bachelor of Science at the University of Sydney and a Bachelor of Science (Honours) at Macquarie University and in 1997 she was awarded a PhD (Medicine) at the University of NSW. In 2005 she completed a Master’s Degree in Industrial Property at the University of Technology. Renee has been Director at Engel Hellyer & Partners since 2013.