The Therapeutic Goods Administration (TGA) has outlined new testing reforms for sun protection products after a major testing controversy. The new Australian sunscreen testing rules require manufacturers to test finished sunscreens, submit results before listing products, and repeat testing throughout their shelf life.
The proposed changes also cover laboratory accreditation, ingredient quality and sunscreen labelling.
About the Australian Sunscreen Safety Scandal In 2025
The New Australian sunscreen regulations follow findings by consumer group CHOICE that 16 of 20 sunscreens tested in June 2025 failed to meet their advertised Sun Protection Factor (SPF) claims.
One sunscreen advertised as SPF 50+ returned a test result of just SPF 4 and was subsequently recalled. Other products sharing its base formula were also affected.
The Australian sunscreen safety scandal raised concerns about whether sunscreen labels accurately reflected the protection consumers received. Reliable SPF claims are particularly important in Australia, where skin cancer presents a significant public health concern.
The TGA’s sunscreen investigation and subsequent consultation prompted a broader review of how manufacturers test products and demonstrate their performance.
Key Changes In New Australian Sunscreen Testing Rules
The proposed TGA sunscreen reforms would introduce several changes to how manufacturers establish and maintain sunscreen protection claims.
1. Testing Finished Products Before Sale
Under the proposed new Australian sunscreen testing rules, manufacturers would have to test the finished sunscreen rather than rely solely on results from its base formula.
Companies would also need to submit their SPF testing results confidentially to the TGA before listing products for sale. Currently, manufacturers generally do not have to submit these results unless the regulator requests them.
2. Repeat Testing Throughout Shelf Life
Manufacturers would have to conduct further SPF testing at appropriate intervals while their products remain on the market.
This requirement in the Australian sunscreen regulations could help identify whether a sunscreen continues to support its advertised protection claims over time. However, the TGA has not yet specified the exact frequency of repeat testing.
3. Stronger Laboratory Accreditation
The TGA sunscreen reforms proposal would strengthen international accreditation requirements for laboratories conducting sunscreen tests.
Stronger accreditation could improve testing quality, although the TGA acknowledges that it may increase costs and make testing services harder to access. It will address concerns related to inconsistent testing results and the reliability of some laboratory assessments.
New SPF Testing Methods Could Change Sunscreen Regulation
The TGA has proposed allowing manufacturers to use in vitro testing, a laboratory method that assesses sunscreen without applying it to human skin. This would provide an alternative to in vivo testing, which measures protection by applying sunscreen to human volunteers and assessing their response to simulated ultraviolet exposure.
The Australian regulator cited variability in results from human testing as a reason to consider alternative methods. However, in vitro testing would not replace human testing in every situation, particularly for certain formulations and water-resistance assessments. The aim is to improve testing reliability while allowing methods suited to different products.
Clearer Sunscreen Labeling & Stronger Ingredient Standards
The new Australian sunscreen testing rules would also address how brands communicate protection claims.
Proposed measures include:
- Cosmetic sunscreen claims: Limiting SPF claims for cosmetic products where sun protection is not their primary purpose.
- Ingredient quality: Developing quality requirements for specific sunscreen ingredients.
- Manufacturing standards: Reviewing guidance on good manufacturing practices.
- SPF labelling: Considering alternative categories such as low, medium, high and very high instead of numerical ratings.
The sunscreen labelling proposals remain under review and are not finalised requirements.
CHOICE Raises Concerns About Testing Transparency
CHOICE has welcomed stronger testing requirements but argues that the proposals do not go far enough. The consumer group wants the TGA to routinely evaluate submitted results, conduct its own compliance testing and make SPF test data publicly available.
Under the current proposal for new Australian sunscreen testing rules, results would remain confidential, and the regulator would not routinely evaluate every submission before products reach the market.
Industry representatives have also warned that additional testing and accreditation requirements could increase costs, delay product availability and create supply pressures during the transition.
TGA Sunscreen Reforms To Take Effect in Stages
The TGA plans to introduce the reforms in stages. Some changes could proceed in the short term, while others may require further consultation or legislative amendments.
The regulator has not confirmed a complete implementation timeline. The effect on sunscreens already available in Australia also remains unclear.
The TGA also states that it is still developing the new Australian sunscreen testing rules.
