The TGA outlined the proposed changes on Tuesday, following an independent test by consumer group Choice that found 16 of 20 sunscreens fell short of their sun protection promises. One sunscreen listed as SPF50+ returned an actual SPF of just four. The scandal led to a wave of product recalls.
Under current rules, manufacturers do not have to provide SPF testing data for the final product when applying for registration on the Australian Register of Therapeutic Goods (ARTG). They can instead rely on verification of base formulas, before customising the product in ways that may affect performance.
The TGA now intends to require manufacturers to submit SPF test results for the finished product before approval, and to provide that data on a confidential basis before the products reach shelves. Brands would also need to test their packaged products at various points during their shelf life to ensure performance does not deteriorate over time.
Testing methods could also change. Currently, sunscreens are tested in vivo, meaning they are applied to human subjects and exposed to infrared light. The TGA wants to allow in vitro testing, where the product is tested in isolation, to reduce variation across skin types.
In addition, the regulator is considering limiting SPF claims on cosmetic sunscreens, skincare products with auxiliary UV-blocking benefits. A broader review of the SPF rating system, which may replace numbers like SPF15 and SPF50+ with a scale from 'Low' to 'Very High', will follow further consultation.
'Sunscreen sponsors and manufacturers understand their regulatory obligations,' the TGA said. Some changes could take effect soon, while others require legislative changes and additional consultation.
