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Australia TGA Strengthens Sunscreen Regulation to Improve Confidence in SPF Claims

Nov 3, 2026
Australia
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On October 27, 2026, the Therapeutic Goods Administration (TGA) of Australia issued a media release announcing that it is progressing with reforms to strengthen sunscreen regulation, in order to improve consumer confidence in sun protection factor (SPF) claims. The reforms to be progressed include strengthening sunscreen testing requirements, developing quality requirements for specific sunscreen ingredients, limiting the SPF claims that cosmetic sunscreens can make, and revising the Good Manufacturing Practice (GMP) guide for sunscreen products.

The reforms are based on the public consultation conducted by the TGA from March to May 2026, which received nearly 120 responses from industry, testing laboratories, health professionals, consumer groups, academia and other stakeholders.

Background of the Reforms

Australia has the highest incidence of skin cancer in the world, and sunscreen is a key means of protecting consumers from ultraviolet (UV) radiation and reducing the incidence and impact of skin cancer. The primary objective of sunscreen regulation is to ensure the quality, safety and efficacy of sunscreen products. These reforms aim to strengthen consumer confidence in the performance of sunscreen products, and to ensure that sunscreen sponsors and manufacturers clearly understand their regulatory obligations.

Four Reforms to Be Progressed

1. Strengthening sunscreen testing requirements to improve the confidence and reliability of SPF claims;

2. Developing quality requirements for specific sunscreen ingredients to ensure that sunscreens containing these ingredients are of good quality and perform as expected;

3. Limiting the SPF claims that cosmetic sunscreens can make, so that sunscreens primarily used for UV protection are clearly distinguished from secondary (cosmetic) sunscreens at the consumer level;

4. Revising the GMP guide for sunscreen products to clarify regulatory expectations and the responsibilities of each party, strengthen manufacturing outcomes, and support continued confidence in the quality and performance of sunscreens in Australia.

Next Steps

Further review and consultation on SPF labelling will be conducted at a later stage, before any decision is made on whether to proceed with related labelling changes. The TGA is currently working with academic and industry experts to obtain advice on the factors underpinning the quality, efficacy and safety of sunscreens in Australia.

Stakeholders can follow the progress of the reforms through the TGA's “Sunscreen reforms” web page, social media and email updates.

CIRS Reminder

In Australia, sunscreens primarily used for UV protection are regulated as therapeutic goods, while different requirements apply to some secondary (cosmetic) sunscreen products. These reforms will clearly tighten the scope for SPF claims on cosmetic sunscreens, and the enterprises concerned should assess whether their product positioning and claims strategies need to be adjusted.

Enterprises exporting sunscreen products to Australia should pay attention to the direction in which SPF testing requirements are being strengthened and verify the reliability of their SPF testing data in advance; they should also track the impact of the quality requirements for specific sunscreen ingredients and the revision of the GMP guide on formulations and production management documentation. CIRS will continue to monitor the implementation of the reforms and provide timely regulatory updates.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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