Australia Proposes Stronger SPF Testing and Claim Rules

By Tom Whitfield

Australia’s Therapeutic Goods Administration proposed requiring SPF testing of finished sunscreen products at listing and periodically during registration in the Australian Register of Therapeutic Goods (ARTG). The package responds to a testing dispute that prompted product withdrawals, a regulatory investigation and dozens of recalls.

Together, the reforms would change how sponsors substantiate SPF claims, how laboratories are accredited, and how ingredient quality, manufacturing and cosmetic claims are controlled. The TGA said stronger testing should improve claim reliability and consumer confidence in sunscreen labels.

In a statement, the regulator said the changes should “ensure their quality, safety and efficacy to protect consumers from the sun’s harmful ultraviolet (UV) radiation, to reduce the incidence and impact of skin cancer.” That goal sits directly behind the proposed overhaul.

Why is Australia tightening sunscreen rules?

The move follows an investigation by Australian consumer watchdog Choice, launched after its testing last year found several sunscreens returned SPF levels below those stated on their labels. A number of brands pulled products from shelves, and the TGA opened its own investigation.

Choice’s lowest result came from Ultra Violette Lean Screen SPF 50+, which returned an SPF of just four despite its label and was voluntarily recalled. The TGA found that the base formula used in Lean Screen SPF 50+ also appeared in products from several other brands. Dozens of sunscreen products from a number of brands have since been recalled.

The reform package spans product evidence, laboratory oversight, ingredient specifications, manufacturing standards and labeling. It would also distinguish sunscreens marketed for primary UV protection from those sold with secondary cosmetic purposes.

What testing changes would the TGA introduce?

The TGA proposes strengthening testing requirements to improve the reliability of SPF claims and consumer trust in them. Four elements define the proposed testing framework:

• Sponsors could use in vitro and in vivo testing where appropriate, but they would have to provide testing data to the TGA when a product is listed. The regulator would hold that information confidentially.
• The TGA would require SPF testing on the finished product at listing and periodically while it remains in the ARTG.
• The agency would strengthen accreditation of laboratories that conduct sunscreen testing.
• Legislation would directly reference International Organization for Standardization (ISO) standards.

Taken together, the proposals require product-specific evidence from the finished sunscreen, alongside stronger laboratory accreditation and periodic checks during ARTG registration. The confidential submission process would give the regulator testing data without making those documents public.

How would ingredient and manufacturing rules change?

The TGA would develop quality requirements for specific sunscreen ingredients. It said products containing those ingredients should be of high quality and perform as expected, linking ingredient specifications to finished-product performance.

The regulator also proposed new limits on SPF claims for cosmetic sunscreens. Those limits would create a clear distinction for consumers between sunscreens used primarily for UV protection and secondary, cosmetic sunscreens.

Separately, the TGA plans to review its sunscreen good manufacturing practice (GMP) guidance. The review would clarify manufacturers’ expectations and responsibilities, strengthen manufacturing outcomes and support confidence in Australian sunscreen quality and performance.

Where do consultations and label rules stand?

A three-month consultation earlier this year drew nearly 120 responses from industry, testing laboratories, health professionals, consumer groups, academia and other stakeholders. The consultation covered the proposed reforms before any final implementation rule took effect.

The TGA now plans another review and consultation on SPF labeling. That follow-up follows mixed views on a proposal to change how SPF ratings appear on sunscreen labels, leaving the display format unsettled.

The agency has not put forward a timeline for implementing the package. It said each reform “will take time to develop and will be implemented in a proportionate and targeted manner.”

The next milestones are development of the testing, laboratory, ingredient and manufacturing requirements, plus another SPF-label consultation. The TGA has not dated those steps, so the proposal’s operational details and implementation schedule remain unresolved.