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Australia’s Therapeutic Goods Administration has proposed stronger testing and quality rules for sunscreens after consumer testing raised concerns about SPF claims. The proposals include requiring test data when products are listed and periodic testing of finished products, but the TGA has not set an implementation timeline.
Australia’s Therapeutic Goods Administration (TGA) has proposed tougher sunscreen testing and quality rules after an investigation into products whose measured sun protection factor (SPF) fell below the levels on their labels. The measures are intended to improve the reliability of SPF claims and consumer confidence, but the regulator has not announced when the changes will take effect.
Under the proposals, companies responsible for sunscreen products would have to provide testing data to the TGA when a product is listed on the Australian Register of Therapeutic Goods (ARTG). The regulator says it would hold that information confidentially. Testing would be required on the finished product at the time of listing and periodically while it remains on the register. The proposed framework would allow in vitro and in vivo testing where appropriate, and would strengthen requirements for accredited testing laboratories.
The TGA also plans to refer directly to International Organization for Standardization (ISO) standards in legislation and develop quality requirements for certain sunscreen ingredients. It has proposed limits on SPF claims for cosmetic sunscreens, aiming to distinguish products primarily intended for UV protection from those where sun protection is a secondary, cosmetic function. A review of sunscreen good manufacturing practice guidance is also planned.
The regulator said the package followed a three-month consultation with industry, laboratories, health professionals, consumer groups, researchers and other stakeholders. It received nearly 120 responses. The TGA said the reforms would take time to develop and be introduced in a proportionate, targeted way, but it has not given a schedule.
How Testing Rules Could Change
Sunscreen labels guide consumers choosing protection from ultraviolet radiation, so unreliable SPF claims can affect whether a product provides the level of protection people expect. The proposed requirement for data at listing, alongside repeat testing of finished products, would give the TGA more direct access to evidence supporting those claims while products are on the ARTG.
The reforms also address more than the test result itself. Laboratory accreditation, ingredient quality and manufacturing guidance can affect whether products are made and assessed consistently. For consumers, the intended outcome is greater confidence in labelled protection; for manufacturers and sponsors, the proposals could mean additional testing, documentation and quality responsibilities. The detailed costs and compliance arrangements have not been set out in the available report.
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The SPF Testing Concerns Behind the Plan
The proposals follow findings by Australian consumer group Choice, which reported last year that several sunscreens it tested produced SPF results below the levels stated on their packaging. The findings prompted some brands to withdraw products and led the TGA to investigate sunscreen claims. The report says dozens of products from multiple brands have since been recalled.
In one example described in the report, the TGA identified a base formula used in Ultra Violette’s Lean Screen SPF 50+, a product that Choice’s testing returned at an SPF of four and that was voluntarily recalled. The TGA found the formula was also used by other brands. These details describe the reported investigation and consumer testing; they do not establish that every product using the formula, or every sunscreen on the market, failed to meet its label claim.
The TGA’s broader reform plan follows its consultation on possible changes to sunscreen regulation. A separate proposal about how SPF ratings should appear on labels drew mixed views, the regulator said. It plans further review and consultation on SPF labelling rather than treating that question as settled.
“The measures are intended to “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
Timeline and Label Rules Remain Open
The TGA has not provided an implementation timetable, nor has it published final requirements in the supplied report. The proposed use of in vitro and in vivo testing “where appropriate” leaves the specific circumstances and protocols to be clarified. Details such as the frequency of periodic testing, the accreditation standards for laboratories and the quality criteria for selected ingredients are also not specified here.
It is also unclear what limits would apply to SPF claims for cosmetic sunscreens, or how any revised classification would affect products already listed. Changes to the presentation of SPF ratings are not settled: the TGA said consultation responses were mixed and that it would conduct further review. The reported test results that prompted the investigation should not be read as evidence that all Australian sunscreens have inaccurate claims.
Further Consultation Before Implementation
The TGA says it will continue developing the proposed reforms and carry out a further review and consultation on SPF labelling. The next public milestones would be the release of more detailed requirements, including how testing methods, laboratory accreditation, repeat testing and cosmetic SPF limits would work in practice.
Until the regulator sets out a timetable and final rules, the proposals are not yet confirmed as operative requirements. Consumers and businesses will need to watch for TGA updates on the consultation process and any transition arrangements for products already listed on the ARTG.
Key Questions
What sunscreen changes has Australia proposed?
The TGA proposes stronger testing rules, test data supplied when a product is listed, periodic testing of finished products, stronger laboratory accreditation and quality requirements for some ingredients. It also proposes limits on SPF claims for cosmetic sunscreens and a review of manufacturing guidance.
Why is the TGA proposing tougher rules?
The proposals follow Choice testing that found several sunscreens had measured SPF results below the levels stated on their labels. The findings prompted product withdrawals and a TGA investigation.
Are the new requirements already in force?
No implementation date has been announced. The TGA says the reforms will take time to develop and will be implemented in a proportionate, targeted way.
Will sunscreen labels change?
That remains under review. The TGA reported mixed views on a proposal to change how SPF ratings are displayed and said it plans further review and consultation.
Does the testing concern mean all Australian sunscreens are unreliable?
No. The source report describes concerns about several products tested by Choice and subsequent recalls. It does not establish that every sunscreen sold in Australia failed to meet its labelled SPF.
Source: cosmeticsbusiness.com
