The Therapeutic Goods Administration has announced proposed reforms to sunscreen regulation that would require manufacturers to submit SPF test data on finished products before listing, ABC News reported, replacing the current practice of relying on base formula results. Under the changes, SPF test results would be provided to the TGA on a confidential basis, and manufacturers would need to test their packaged products at multiple points during shelf life.
The reforms follow Choice testing that found 16 of 20 popular sunscreens fell short of their SPF label claims. Seven products carrying SPF 50 or SPF 50+ labels returned results in the 20s range, with others recording figures in the 30s and 40s. Ultra Violette pulled its Lean Screen SPF 50+ product from sale in August after its own investigation generated eight SPF figures ranging from four to 64, having first disputed Choice results that recorded an SPF of four and five across two laboratories.
At present, sunscreen makers face no routine obligation to give the TGA their SPF testing data unless specifically asked, and may build on base formula test results rather than testing the final customised product. The TGA is proposing to limit SPF claims that cosmetic sunscreens can make and to clarify the distinction between cosmetic and therapeutic sunscreens.
International accreditation would be mandatory for any laboratory performing SPF tests on sunscreens destined for the Australian market. Alongside the existing in vivo method, which involves applying sunscreen to human subjects, the TGA is proposing to permit in vitro testing that evaluates sunscreens in isolation.
The TGA said the proposed changes are aimed at building consumer confidence in sunscreen performance and ensuring that sponsors and manufacturers understand their regulatory obligations. Close to 120 submissions shaped the reforms during a consultation period running from March to May this year. The regulator is still considering changes to the SPF labelling system, with one option being a shift from number-based ratings to descriptors including low, medium, high and very high.
Choice backed the reforms in principle but wants SPF test results released publicly and the TGA to run its own compliance testing rather than depend solely on results provided by manufacturers. Choice director of consumer impact Andy Kelly said the proposal stops short of routine monitoring and evaluation of test results.
Sunscreen brands and manufacturers would face higher testing and development costs before products can go to market if the reforms proceed. Australia ranks among the countries with the highest skin cancer rates globally, with roughly two in three Australians expected to receive a skin cancer diagnosis in their lifetime.
Reporting: SmartCompany, ABC News, 7NEWS
Written by Pick & Scroll News from the reporting and documents linked above.
