Tough new testing rules for sunscreens in the wake of SPF scandal

Australian sunscreen brands would be forced to test the SPF of their products multiple times and provide the results to the regulator before going to market, under stricter rules designed to restore public confidence in sunscreens.

Consumer faith was battered last year when Choice testing revealed 16 out of 20 popular sunscreens failed to meet their SPF label claims.

One 50+ sunscreen that returned an SPF result of just four was later recalled, followed by 19 others which shared the same base formula.

The proposed changes have been put forward today by Australia's medicines regulator, the Therapeutic Goods Administration (TGA).

"Our investigation has identified multiple factors that could contribute to low SPF results — not a single cause," chief medical advisor Robyn Langham said.

"Australians expect the SPF on the label to be backed by robust evidence. These proposed reforms put that expectation at the centre of sunscreen regulation."

The TGA told the ABC some of the changes could be implemented in "the short term" while others would require further consultation and may need legislative amendments.

SPF testing won't be made public

Currently, sunscreen makers do not have to provide SPF testing data to the TGA unless requested, meaning there is limited transparency around the evidence underpinning a rating.

Under the proposed changes, brands would need to do SPF testing on their finished product before listing it with the TGA, rather than just the base formula.

They would also need to continue to test the sunscreen periodically over its shelf life.

Additionally, brands would be required to provide their SPF test results to the TGA, on a confidential basis, before the sunscreen can go to market.

"This is about making SPF claims more reliable, reinforcing suppliers' responsibility for their products and giving the TGA faster access to evidence when concerns arise," Professor Langham said.

But in a document explaining the proposals, the TGA said it would not routinely check SPF testing data before a product hit the shelves.

The TGA considered requiring making SPF testing to be made public. However in its proposal it noted that there were concerns about confidentiality, intellectual property and potential misinterpretation of highly technical SPF data.

The TGA has not released the results of its investigation into Choice's sunscreen testing from more than a year ago, and it is unclear how the proposed reforms will affect sunscreens already on the market.

TGA to expand how sunscreens can be tested

One of the most significant changes proposed is to how sunscreens would be tested before entering the market.

Companies would be allowed to test their products using an "in vitro" method, which involves testing sunscreen by putting sunscreen onto a plastic plate instead of human skin.

Currently products must be tested using "in vivo" test methods, which involves applying sunscreen to volunteers and measuring how effective it is under simulated sunlight UV exposure.

The TGA said it made this recommendation due to significant concerns about variability in SPF testing results using the in vivo testing method.

It said in vivo would not be replaced entirely, because the in vitro method may not be suitable for some formulations or water-resistant SPF testing.

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The TGA has also proposed improvements to oversight of laboratories performing SPF testing, as it currently does not regulate or accredit them.

Under the changes, the TGA is proposing strengthened international accreditation of testing labs. 

It comes after an ABC investigation revealed more than half of the sunscreens that failed to meet their SPF label claims had used an overseas lab, which had its results called into question by experts.

The TGA acknowledged the measure could make testing more expensive and harder to access.

Other proposed changes to sunscreen rules include:

• Making the difference between cosmetic and therapeutic sunscreens clearer — currently, some cosmetic products are able to claim an SPF of up to 50+ without being listed as therapeutic goods.
• Developing quality requirements for sunscreen ingredients in response to a range of views on whether the current regulations provide "sufficient assurance of the quality, safety and efficacy of sunscreen ingredients and formulations".
• Conducting a review of sunscreen good manufacturing process guidance.

The TGA said it was still considering changes to how SPF is labelled on sunscreen packaging.

Three options were proposed during consultation, including moving from the current number-based system to a "low", "medium", "high" and "very high" format.