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Australia’s Therapeutic Goods Administration has proposed stricter sunscreen testing and quality rules after consumer testing found some products delivered less SPF protection than their labels stated. The proposals include submitting testing data when products are listed, periodic testing and tighter laboratory accreditation; an implementation timetable has not been set.
Australia’s Therapeutic Goods Administration (TGA) has proposed tougher sunscreen rules, including stricter SPF testing and requirements for companies to provide test data when products are listed, after consumer testing found some sunscreens delivered less protection than their labels claimed. The reforms aim to strengthen confidence in SPF claims, but the regulator has not announced when the changes will take effect.
Under the proposed system, sponsors would need to provide sunscreen testing data to the TGA when a product is added to the Australian Register of Therapeutic Goods (ARTG). The regulator says it would hold the information confidentially. Testing requirements would be strengthened, with companies able to use in vitro and in vivo methods where appropriate. SPF testing would also be required on the finished product at the time of testing and periodically while it remains on the ARTG.
The plans also include stronger accreditation requirements for testing laboratories and direct references to International Organization for Standardization (ISO) standards in legislation. The TGA said it would develop quality requirements for certain sunscreen ingredients, and review good manufacturing practice guidance to clarify responsibilities and strengthen manufacturing outcomes.
Separate proposed limits on SPF claims for cosmetic sunscreens are intended to distinguish products whose primary purpose is UV protection from those where sun protection is a secondary function. A further review and consultation on how SPF ratings appear on labels is planned: the TGA said views on a possible labelling change were mixed in the earlier consultation.
How Testing Rules Could Change
The proposals would place more emphasis on documented evidence before and after listing, rather than relying solely on the SPF claim printed on a product. Requiring data to be provided to the regulator and testing the finished formulation could give the TGA more information to check how products perform and whether claims remain supported over time.
That matters because sunscreen labels guide consumer decisions about protection from ultraviolet radiation. If a product does not deliver the protection indicated by its SPF rating, people may have less protection than they expect. The TGA says the proposed reforms are intended to protect consumers and reduce the incidence and impact of skin cancer; the measures are regulatory proposals, not evidence that every product currently on the market is unreliable.
For manufacturers and testing laboratories, the changes could mean additional testing, record-keeping and quality-control work. The precise obligations and costs cannot yet be assessed because the detailed rules and implementation schedule have not been released.
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Why the TGA Began Its Review
The reforms follow an investigation prompted by findings from Australian consumer group Choice. Last year, Choice reported that several sunscreens it tested returned SPF levels below those stated on their packaging. Some brands subsequently withdrew products from sale, and the TGA opened its own investigation into sunscreen claims.
The source report says the TGA identified a base formula used in Ultra Violette’s Lean Screen SPF 50+, which was voluntarily recalled after returning the lowest result in Choice’s tests, as also being used by products from other brands. Dozens of sunscreen products from multiple brands have since been recalled, according to the report. Those recalls and test results are part of the scrutiny behind the proposed regulatory response; they do not establish that all sunscreens, or all products using a related formula, have the same performance issue.
Before setting out the proposals, the TGA consulted industry, testing laboratories, health professionals, consumer groups, academics and other stakeholders over three months earlier this year. The consultation received nearly 120 responses. The regulator has not published a final implementation timetable.
““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””
— Therapeutic Goods Administration
Timetable and Final Rules Remain Open
The TGA has not provided a date for when any reform will begin, or detailed the final requirements that sponsors and laboratories would have to meet. The proposals are not yet a complete set of enacted rules, and the regulator says each measure will take time to develop.
The approach to SPF labelling also remains unresolved. The regulator plans further review and consultation because responses to the initial labelling proposal were mixed. It is not yet clear what limits would apply to SPF claims for cosmetic sunscreens, which ingredients would receive specific quality requirements, or how often periodic testing would be required.
The source report does not provide final findings from the TGA’s investigation into the products that prompted the review. Consumers should not infer from the proposed changes alone that every sunscreen is affected; the reported concerns relate to particular test results and products.
Further Consultation and Rulemaking
The TGA is expected to develop the individual reforms and conduct a further review and consultation on SPF labelling. It has said implementation will be proportionate and targeted, but has not stated when it will publish final rules or a rollout schedule.
For now, the next concrete milestones are the regulator’s detailed decisions on testing evidence, laboratory accreditation, ingredient quality, manufacturing guidance and cosmetic-sunscreen claims. Until those are published, the scope and timing of the new obligations remain unsettled.
Key Questions
What sunscreen changes is Australia proposing?
The TGA proposes stronger SPF testing and quality requirements, testing data supplied when a product is listed, periodic testing of finished products, stronger laboratory accreditation and direct references to ISO standards in legislation. It also plans ingredient quality requirements and revised manufacturing guidance.
Why did the TGA propose tougher rules?
The review followed Choice testing reported last year that found several sunscreens returned SPF results below their labelled ratings. Brands withdrew some products, and the TGA began an investigation.
When will the new sunscreen rules take effect?
No implementation date has been announced. The TGA says each reform will take time to develop and will be introduced in a proportionate and targeted manner.
Will SPF labels change?
That remains undecided. The TGA plans another review and consultation on SPF labelling after receiving mixed views on a proposed change during the earlier consultation.
Do the proposals mean all Australian sunscreens are unreliable?
No. The reported testing concerns involved particular products and results. The proposals are intended to strengthen oversight; they do not establish that all sunscreens fail to meet their labelled SPF.
Source: cosmeticsbusiness.com
