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Australia’s Therapeutic Goods Administration has proposed tougher sunscreen testing, ingredient-quality and manufacturing requirements to improve confidence in SPF claims. The proposals follow consumer testing that found some products delivered lower SPF protection than their labels stated; the TGA has not set an implementation timetable.
Australia’s Therapeutic Goods Administration (TGA) has proposed stricter sunscreen testing and quality rules following concerns that some products did not meet the SPF levels stated on their labels. The planned changes would require sponsors to provide testing data when products are listed, strengthen oversight of testing laboratories and introduce repeated testing of finished products.
The proposals are intended to improve the reliability of sun protection factor (SPF) claims and consumer confidence in sunscreens. Under the outlined approach, sponsors could use in vitro and in vivo testing where appropriate, and would have to submit the supporting data to the TGA when listing a product. The regulator says it would hold that information confidentially.
The proposed package also includes stronger accreditation requirements for laboratories and direct references to International Organization for Standardization (ISO) standards in legislation. SPF testing would be required on the finished product at the time of testing and periodically while it remains on the Australian Register of Therapeutic Goods. The TGA also plans to develop quality requirements for certain sunscreen ingredients.
Other proposed measures include new limits on SPF claims for cosmetic sunscreens, intended to distinguish products whose primary purpose is UV protection from those where sun protection is secondary. The TGA also plans to review its guidance on good manufacturing practice for sunscreens. It said the reforms would be developed and introduced in a proportionate, targeted way, but has not announced dates.
Tighter Checks on SPF Claims
The proposals could change what sunscreen makers must demonstrate before and after products are sold in Australia. Requiring data at listing and further testing during a product’s time on the register would give the regulator more information to assess whether labelled SPF claims are supported. Stronger laboratory accreditation and manufacturing guidance are also aimed at the reliability of the testing and production behind those claims.
For consumers, SPF labels help guide choices about protection from ultraviolet radiation. The TGA said the reforms are intended to protect people from UV exposure and reduce the incidence and impact of skin cancer. That is the regulator’s stated rationale, not a finding that the proposed rules by themselves will reduce cancer rates. The practical effect will depend on the final requirements, their enforcement and how products perform under the revised system.
Limits on SPF claims for cosmetic products could also make it easier for shoppers to distinguish products marketed primarily as sunscreen from cosmetics that include sun protection as an additional feature. The exact limits and how labels may change remain subject to further work.
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Testing Concerns Prompt Review
The reform process follows an investigation into sunscreen claims that began after consumer watchdog Choice reported last year that several products it tested returned SPF results below the levels stated on their packaging. According to the supplied report, the findings prompted some brands to remove products from sale and led the TGA to investigate.
The report says the TGA identified a base formula used in Ultra Violette’s Lean Screen SPF 50+ that was also used by several other brands. Choice’s testing had returned an SPF of four for that product, which was voluntarily recalled. The report also says dozens of products from a number of brands have since been recalled. Those past test results and recalls provide the immediate backdrop to the regulator’s proposed changes; they are distinct from the new rules, which have not yet been implemented.
Before outlining the measures, the TGA consulted industry, testing laboratories, health professionals, consumer groups, academics and other stakeholders for three months earlier this year. The consultation received nearly 120 responses. The regulator said views were mixed on one suggestion: changing how SPF ratings appear on labels. It plans a further review and consultation on SPF labelling.
““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
Final Rules and Timing Pending
The measures remain proposals rather than rules in force. The TGA has not published an implementation timetable, detailed technical requirements or the final limits for SPF claims on cosmetic sunscreens. It also has not resolved how SPF ratings should be displayed: the consultation produced mixed views, and another review is planned.
The supplied report does not specify which testing methods would be appropriate for particular products, how often periodic testing would occur, or what consequences would apply if a product failed testing. Those details will matter to manufacturers and consumers, but they cannot yet be treated as settled. The regulator says each reform will take time to develop.
Further Review and Rulemaking
The TGA says it will continue developing the proposed measures, including laboratory accreditation, ingredient-quality requirements and revised manufacturing guidance. It also plans a further review and consultation on SPF labelling, following the mixed feedback on how ratings should appear.
The next major development will be publication of more detailed requirements and a timetable for implementation. Until those are announced, the proposals do not change the current rules. The supplied report does not give a date for the next consultation or identify when the TGA expects to complete the reforms.
Key Questions
What sunscreen changes has Australia proposed?
The TGA has proposed stronger SPF testing and laboratory accreditation, submission of testing data when products are listed, periodic testing of finished products, ingredient-quality requirements, new limits on SPF claims for cosmetic sunscreens and revised manufacturing guidance.
Why is the TGA proposing tougher rules?
The proposals follow concerns raised after Choice reported that some tested sunscreens returned SPF levels below those on their labels. The TGA says the reforms are intended to improve the reliability of SPF claims and consumer confidence.
Are the proposed rules already in effect?
No. They are proposed reforms. The TGA has not announced an implementation timetable, and the requirements still need to be developed.
Will sunscreen labels change?
That remains unsettled. The TGA plans another review and consultation on SPF labelling after receiving mixed views on a proposal to change how SPF ratings are displayed.
When will the changes take effect?
No date has been announced. The TGA said the reforms will take time to develop and will be implemented in a proportionate, targeted manner.
Source: cosmeticsbusiness.com
