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A new standard is now in force — and the clock is already running
Since 1 July 2024, every new sunscreen entered on the Australian Register of Therapeutic Goods must comply with the updated sunscreen standard, AS/NZS 2604:2021. If you are bringing a new SPF product to market, the old 2012 standard is no longer an option — the 2021 version applies from day one.
For products already on the ARTG, there is breathing room, but it is finite. Two separate transition clocks are ticking, and they run for very different lengths of time.
The two transition periods that matter
The change didn't switch everything over at once. The TGA set staggered deadlines depending on whether the issue is your label or your testing:
- Labelling — 1 year (aerosols and spray pumps). Existing aerosol and spray-pump sunscreens on the ARTG before 1 July 2024 were given a one-year window to meet the new labelling requirements. That window has effectively closed, so these presentations should already be compliant.
- Testing — 5 years (all products). Every existing sunscreen on the ARTG before 1 July 2024, aerosol or not, has until mid-2029 to move to the 2021 testing requirements. Until then it may continue to rely on either the 2021 standard or the old 2604:2012. After that, there is no fallback.
The five-year testing runway sounds generous. In practice, SPF and broad-spectrum testing takes planning, laboratory time and budget — and it competes with every other brand doing the same thing before the same deadline. Leaving it to 2028 is how a comfortable timeline becomes a scramble.
What actually changed in the standard
The 2021 update brings Australia into line with current international testing methods by incorporating three updated ISO standards:
- ISO 24444:2019 — SPF testing
- ISO 24443:2021 — UVA (broad-spectrum) testing
- ISO 16217:2020 — water-resistance testing
One notable change sits inside the SPF method: it moves away from the Fitzpatrick scale for characterising skin type and instead uses the Individual Typology Angle (ITA), a more precise, measured way of quantifying skin colour in test panels. For most brands this is a testing-house detail rather than something you handle directly — but it can affect how and where your testing is done, and whether older test data still holds up.
Who should be checking their products now
The move matters most if you:
- Sell primary sunscreens or higher-SPF secondary sunscreens, which are therapeutic goods and sit squarely inside this standard
- Hold existing ARTG entries relying on 2012-era test data that will need to be re-tested before the 2029 cutoff
- Are importing an overseas SPF range whose testing was done to a different international method and may not map cleanly onto the 2021 requirements
- Market aerosols or spray pumps, where the labelling transition has already passed
Where Engel Hellyer & Partners fits in
Sunscreen is one of the most complex regulatory areas in Australia, and the 2021 standard adds a layer of transition planning on top of the usual classification questions. We help brands work out which products are affected, what the 2021 standard requires for each, and how to sequence any re-testing and relabelling so it lands well before the deadline rather than against it.
If you have SPF products on the market or in development, a short review now will tell you where each one sits and what — if anything — needs to happen before the transition periods run out. It's a good deal easier to plan for than to catch up on.
If that would help, we're happy to take a look.
This article is general information only and does not constitute regulatory advice for any specific product. Regulatory requirements and transition dates change; confirm the current position before acting.
Further reading
Primary guidance from the Therapeutic Goods Administration:
- Updates to the Sunscreen Standard
- Australian/New Zealand Sunscreen Standard AS/NZS 2604:2021 — adoption paper (PDF)
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