On 21 November 2025, Accord (the voice of the hygiene, cosmetic, and personal care industry in Australia), brought together industry leaders, regulatory experts, and manufacturers to discuss the regulatory landscape of sunscreens in Australia. The forum focused on practical challenges affecting the industry and the future direction of the sunscreen sector, which is facing a critical inflection point following the recent Choice survey on Australian sunscreens.
CIE Legal’s Kaye Ho and Hannah Pike provide a summary of the issues discussed.
How different markets regulate sunscreens
Around the globe, sunscreens are generally regulated as either a cosmetic or medicine.
The European Union, for example, takes the former approach, which means lower regulatory hurdles in relation to sunscreen ingredients and claims.
In Australia and the United States of America, sunscreens are regulated as medicines and are subject to much more stringent data, approval and compliance obligations.
Australia’s regulatory hurdles
Excipient approval: Australia is one of the only countries in the world that requires regulatory approval for new excipients (inactive ingredients) in sunscreens. These ingredients often contribute to the all-important ‘skin-feel’ of a sunscreen, which, if too greasy, thick or filmy, can be a significant deterrent to daily sunscreen use. The data requirements are high, even though excipients are usually present in tiny amounts, don’t have therapeutic effects, and are already used in cosmetics and skincare. Increasing approval costs, processing times and evidence requirements creates a barrier to greater innovation.
Staying competitive globally: Australia’s strict regulation on ingredients and manufacturing doesn’t always match international practice. This makes it harder for local manufacturers to compete overseas. Australia was once a hub for sunscreen innovation. However, other countries like New Zealand and Korea now export much more sunscreen than Australia does, highlighting the need for regulatory reform.
Limitations of current testing methods: Current in vivo (human) testing is inherently variable. The industry supports switching to in vitro (lab-based) SPF testing, which is faster, cheaper, and with early evidence of greater consistency. However, the sector still needs clarity on how a transition would be managed, including any inconsistencies between the two methods.
What the industry wants to see
Practical Risk Assessment: The sector is calling for a more practical approach to sunscreen regulation that balances product safety against the significant public health interest in ensuring sunscreen products remain affordable and desirable to Australian consumers.
International alignment: Greater harmonisation with EU and US regulations for sunscreen testing and recognition of excipient ingredients approved for use in key overseas markets would help Australian manufacturers and brands innovate and bring new sunscreens to market.
Better consumer education: The industry sees a need for clearer messaging about sunscreen efficacy, labelling, and safe use. For example, shifting from specific SPF numbers to broader categories like low, medium and high could better reflect the reality that SPF test results can vary and may alleviate consumer confusion.
Conclusion
The Accord Sunscreen Forum made it clear that the Australian sunscreen industry faces some real regulatory and practical challenges, especially around ingredient approvals, testing methods, staying competitive globally and ensuring continued consumer confidence in Australian sunscreens. Industry leaders agree that it’s time for reform. They want a more practical, internationally aligned, and innovation-friendly regulatory framework.
We expect to see changes in the coming years, particularly around SPF labelling, testing methods, and ingredient approvals. We’ll keep you updated as the regulatory roadmap develops.
If you’d like more detail on this topic, or the regulation of cosmetics and therapeutic goods in Australia more broadly, contact Kaye or Hannah.