SPF 'confusion' as sunscreens under investigation not recalled

Almost all the sunscreens that failed to meet their SPF label claims are still being investigated by health authorities nearly a year later, with the nation's medicines regulator conceding the process has "taken a long time".

The Therapeutic Goods Administration (TGA) told a Senate estimates hearing this week it was still investigating 15 of the 16 sunscreens a Choice analysis found fell short of their SPF claims.

Under questioning from independent Senator David Pocock, senior TGA official Avinash Clarke told the hearing the TGA intended to conclude the investigations soon.

"I appreciate your point, Senator, that they have taken a long time," he said.

"We did focus our efforts on those sunscreens that we thought were most unsafe."

The TGA said the sunscreens had not been recalled while they were being investigated, meaning they could still be sold to consumers.

Speaking after the hearing, Senator Pocock told the ABC the process had left Australians in the dark about what sunscreens they should purchase.

"I certainly find it confusing, I am really not that sure what to buy next time I go to buy sunscreen and that is not the situation we want Australians to be in, in one of the countries that has some of the highest skin cancer rates in the world," he said.

"This is the job of the TGA, and this is something that we absolutely have to ensure that we get it on top of soon."

The lowest performing sunscreen in the Choice testing was Ultra Violette's Lean Screen SPF 50+ Mattifying Zinc Sunscreen, which returned a rating of SPF 4.

It was recalled in the wake of the consumer test results, alongside another 19 other sunscreens that shared the same base formula.

But the TGA acknowledged that there was still no outcome from the investigation into the other 15 sunscreens, which did not meet their label claims.

Of those, seven SPF 50 and SPF 50+ sunscreens returned results in the 20s.

Chief executive of sunscreen industry group ACCORD, Damian Mitsch, said: "We're concerned about the impact on consumer confidence in sunscreen that a year-long investigation has had."

But he said it was "important consumers can trust the sunscreens they buy and that we don't recall products that are safe, effective and within scientifically acceptable limits."

TGA taking 'risk-based approach'

In defence of the time frame, TGA chief Tony Lawler said the regulator was taking a "risk-based" approach by triaging sunscreens tested by Choice, starting with those identified as being of the highest risk.

"It's the intersection for us between our safety and quality and effectiveness, but also … the importance of Australians having ready and reasonable access to sunscreens that are effective and safe," Professor Lawler said.

"At the same time as … the work that we're doing on the consultation around testing and labelling and looking at the safety of ingredients, we also recognise that to simply go through and pull all of the described sunscreens off the shelves would also not be in the best service of Australians."

Mr Clarke told the hearing that the TGA had to work through "a large volume of data around those products" and that there was known variability in SPF testing.

He said sunscreens that had an SPF of lower than 50 still provided significant protection.

"The SPF scale isn't a linear scale and so an SPF 30 for example may provide, still provides, 97 per cent protection from UV radiation compared to an SPF 50, which is 98 per cent," he said.

The TGA recently completed a consultation period for a range of changes aimed at overhauling Australia's sunscreen regulations and addressing key concerns facing the country's sunscreen industry.

"I really welcome the steps that the TGA has laid out in terms of a new framework for how they regulate sunscreens and SPF values," Senator Pocock said.

"But … we need urgent action."

An ABC investigation last year revealed that at least half of the sunscreens that failed to meet their label claims had their SPF certification conducted by an overseas laboratory, whose test results had been called into question by senior industry experts.

Princeton Consumer Research had been used by a wide range of sunscreen makers to verify their SPF claims and former employees of the lab told the ABC the company had engaged in questionable testing practices.

The TGA has previously stated it was investigating SPF data from PCR and that it had "significant concerns about the reliability of SPF testing undertaken by Princeton Consumer Research".

When questioned by Senator Pocock about how many sunscreens on the TGA's register of therapeutic goods were relying on SPF data from PCR, the TGA said it did not know.

Mr Clarke told the hearing "the PCR issue is well known to us" and the TGA had encouraged all sunscreen makers who had used PCR to obtain their SPF data "to consider retesting and getting other evidence around their SPF testing".

The TGA said one of the proposals the TGA was considering was moving to an in vitro method, which did not involve human testing and would allow the TGA to conduct its own SPF testing.

TGA representatives told the Senate estimates hearing that it received 117 submissions to its sunscreen regulation proposals.

It said it was going through the submissions, and part of the next steps would be determined based on that feedback.

The regulator foreshadowed it would tackle new SPF testing methods first and other proposals — such as changes to SPF labelling — would likely take more time.