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How SPF Testing Might Change In Light Of The TGA Investigation

How SPF Testing Might Change In Light Of The TGA Investigation

A recent Choice investigation has highlighted that not all sunscreens are created equal. While the consumer reaction has been dramatic, controversial, and at times noisy, the findings have reignited debate over whether the Therapeutic Goods Administration (TGA) should take on in-house SPF testing.

In the past few weeks alone, over twenty well-known sunscreen products have been pulled from the market, including Ultra Violette’s Lean Screen, Naked Sundays’ SPF50+ Collagen Glow Mineral Sunscreen, and Endota’s Mineral Protect SPF50, after it was discovered that five of the seven relied on the same base formula.

The shake-up poses a critical question: is it fair to penalise brands trying to do the right thing when the current system itself may not be equitable?

The current model

At present, sunscreen manufacturers and distributors are responsible for arranging their own SPF testing, often through accredited third-party laboratories. While this approach aligns with global norms, it has weaknesses. Variability in testing methods, reliance on overseas labs, and a lack of transparency can undermine consumer confidence. Cases of sunscreens failing to meet their labelled SPF have further fuelled concerns that oversight may not be strong enough.

Arguments for in-house testing

Advocates argue that in-house testing by the TGA would provide a consistent, centralised system. It would eliminate the risk of “lab shopping,” where brands might choose facilities that deliver favourable results, and ensure all sunscreens are subject to the same rigorous standards. For consumers, this could mean greater trust in SPF claims, and for the industry, a level playing field where compliance is non-negotiable.

Moreover, in-house testing would allow the TGA to quickly respond to public concerns. Rather than waiting for recalls or consumer complaints, the regulator could conduct random audits, spot-checks, or verification testing to ensure products on the shelves match what’s on the label.

The challenges

However, moving SPF testing in-house is not without hurdles. Building and staffing a dedicated laboratory capable of testing hundreds of sunscreen formulations each year would be costly. The process itself is resource-intensive, requiring controlled environments, specialist expertise, and volunteer human testing.

Critics argue that the TGA already faces resource constraints and adding this responsibility could delay approvals, stifle innovation, or increase costs for consumers.

There’s also the question of whether a regulator should act as both policymaker and testing body. Some experts believe oversight is best achieved through independent accredited labs, with the TGA enforcing strict auditing and transparency requirements rather than performing the tests itself.

A hybrid solution?

A middle ground could be a hybrid model. Under this system, the TGA would retain oversight but partner with accredited laboratories in Australia to perform testing. These labs could be subject to regular auditing, with the TGA conducting its own random verification testing to ensure results remain accurate. This model balances the need for consumer protection with practical considerations of cost and capacity.

Thoughts From A Dermatologist

We asked Board-certified Dermatologist (MBBS Hons FACD) Dr Natasha Cook for her thoughts on the matter.

“I believe the TGA should mandate that any sunscreen sold in Australia be approved in accredited Australian testing facilities, with results made publicly available. Creating a system that if problems do arise, they have immediate access to quality control, facility auditing and protects Australian consumers.

It’s always perplexed me why Australian-made sunscreens — both brands and manufacturers — would rely on overseas testing facilities…? Why send products abroad when Australia not only experiences the world’s highest UV levels and has one of the highest rates of skin cancer, but also has world-class local testing facilities?

Studies show Australians experience photoaging up to 20 years earlier than those in the Northern Hemisphere, highlighting the importance of having a local industry that is well regulated and providing SPF we all can rely on and trust.

This transparency takes the guesswork out of what overseas labs have been doing. Ultimately, Australian consumers deserve to trust what’s on the label — not to second-guess it.”

– Dr Natasha Cook, Board-certified Dermatologist (MBBS Hons FACD)

In-vivo VS in-vitro testing

Reika Roberts and Simone Vescio, co-founders of skincare and supplement brand Simka, know all too well the efforts necessary that go with developing sunscreen, having recently launched a variety of SPF products.

When developing SIMKA’s sunscreens, we experienced firsthand just how complex the testing and approval process can be in Australia. Every SIMKA SPF is a proprietary formulation, developed in collaboration with our chemists and manufactured locally – which means we have full oversight and accountability at every stage of production. This level of control is critical for ensuring both efficacy and safety, particularly in a market as stringent as Australia’s.

The current TGA testing model relies on in-vivo testing, meaning results are based on human application. While this remains an important regulatory standard, it has inherent variability, results can differ between individuals and even between laboratories. The TGA’s recent decision to review this model and explore in-vitro (lab-based) methods is a positive step toward greater consistency and reliability.

From a brand perspective, an ideal testing model would combine the strengths of both methods – maintaining the real-world assurance of in-vivo testing while incorporating the reproducibility and precision of in-vitro validation. That’s exactly the hybrid approach SIMKA has adopted. All our sunscreens undergo in-vivo testing to meet TGA requirements, as well as in-vitro testing through accredited Australian laboratories to further substantiate the SPF rating under controlled conditions.

We also conduct annual re-testing of batches already in circulation. Regular testing of active ingredients ensures that each product continues to deliver a stable formulation for its full shelf life, a commitment that gives both clinics and consumers confidence in our brand.

Ultimately, it’s about building trust through transparency and education, so clients feel assured and supported in their daily sun protection.

– Simone Vescio and Reika Roberts, Co-Founders, SIMKA

A statement from the TGA

The TGA’s investigation is ongoing and is currently focused on a comprehensive review and analysis of the high volume of data received from sponsors. Given the complexity and scale of the material involved, this process will take time.

Variability in Sun Protection Factor (SPF) testing results associated with the ISO 24444:2019, Cosmetics Sun protection test methods – In vivo determination of the sun protection factor (SPF) is a known issue. This is due, in part, because it relies on human subjects and a visual estimation of individual skin responses.

The TGA is currently reviewing existing SPF testing requirements. In doing so, the TGA is exploring alternative test methods that may be more reliable, including in vitro test methods.

Through its risk-based approach to the regulation of therapeutic goods, the TGA will take regulatory action as appropriate. For more information on this approach to regulation, please refer to the TGA’s Compliance Management page on its website.

Given Australia’s high incidence of skin cancer, the TGA reiterates that using sunscreen is an important measure to prevent the harmful effects of ultraviolet radiation. This should be combined with seeking shade, wearing a wide-brimmed hat, wearing protective clothing and using sunglasses.

The way forward

Ultimately, the goal is Australians must be able to trust that the SPF number on a bottle of sunscreen reflects the protection they’re paying for. Whether through in-house testing, a hybrid approach, or tighter auditing of third-party labs, the TGA’s role is critical in safeguarding public confidence.

As the conversation continues, sunscreen has been pushed back into the spotlight not as a simple skincare product, but as a frontline defence in Australia’s fight against skin cancer.