Australian Sunscreen Council Urges Adoption of Stricter UV Filter Safety Standards in TGA Submission

Dr Yousuf Mohammed
Aug 5
3 min read

By Dr. Yousuf Mohammed, Expert Member, Australian Sunscreen Council

The primary duty of the Australian Sunscreen Council (ASC) is to ensure the products used by millions of Australians for sun protection are fundamentally safe. It is from this position of public health responsibility that the ASC has provided a formal submission to the Therapeutic Goods Administration's (TGA) consultation on the scheduling of several UV filters.

This regulatory review stems from the TGA's own "Safety Review of Seven Active Sunscreen Ingredients (July 2025)" and the use of the new, comprehensive Australian Sunscreen Exposure Model (ASEM). This model provides a scientifically rigorous assessment of real-world sunscreen use in Australia’s high-UV environment, confirming that exposure levels are significantly higher than those in other parts of the world.

The ASC formally supports the TGA’s evidence-based review process. Our submission endorses the proposed restrictions for Homosalate and Oxybenzone and, further, advocates for a more stringent, zero-tolerance position on the genotoxic impurity, Benzophenone.

Endorsing Science-Based Restrictions for Homosalate and Oxybenzone

Our position is guided by a clear principle: where scientific evidence indicates a potential risk to human health, regulatory action is imperative. The TGA’s safety review, utilising the ASEM, concluded that at their currently permitted concentrations, both Homosalate (15%) and Oxybenzone (10%) result in a Margin of Safety (MoS) below the established benchmark of 100, which is the accepted standard for long-term consumer safety.

Accordingly, the ASC supports the TGA’s most protective regulatory options:

For Homosalate, we endorse the restriction to a maximum concentration of 0.28%. This is the scientifically determined threshold at which its use meets the required Margin of Safety, addressing established concerns regarding its endocrine-disrupting properties.

For Oxybenzone, we endorse the restriction to a maximum concentration of 1.0%. This position is based on extensive data demonstrating its systemic absorption, endocrine activity, and recognized environmental toxicity.

These reforms are scientifically justified and essential for protecting public health in the specific context of Australian exposure patterns.

A Point of Critical Divergence: Our Recommendation for a Zero-Tolerance Stance on Benzophenone

While we are aligned with the TGA on Homosalate and Oxybenzone, our submission strongly opposes the proposed exemption limit of 383 parts per million (ppm) for Benzophenone. The ASC recommends the adoption of a 0% allowable concentration for this substance in all therapeutic sunscreens.

This position is based on three critical factors:

Established Genotoxic and Carcinogenic Risk: A significant body of scientific literature confirms that benzophenone is capable of causing DNA damage, particularly when activated by UV radiation. Its classification as a Group 2B carcinogen by the IARC underscores that its presence in a therapeutic product intended for application to sun-exposed skin presents an unacceptable risk.
The Issue of Chemical Degradation: Benzophenone is a known degradation product of the UV filter octocrylene. Studies confirm that it can accumulate in sunscreen products during storage, particularly under the high-heat conditions common in Australia. A product compliant at manufacture may therefore exceed safe limits before its expiry date, leading to uncontrolled exposure for consumers.
An Insufficient Margin of Safety: The proposed 383 ppm threshold is derived from animal studies in which tumour formation was observed at comparable dose levels. This provides a negligible margin of safety and does not align with the precautionary principle required to protect the public from a known carcinogen.

For these reasons, the only scientifically defensible position is to prohibit the presence of Benzophenone in therapeutic sunscreens, whether it originates as an ingredient, impurity, or degradant.

Industry Capability to Meet Stricter Standards

These necessary regulatory reforms will not compromise the availability of effective sun protection for Australians. The ASC confirms that the domestic industry is already equipped to meet these higher safety standards.

Many Australian manufacturers have proactively formulated their products without these chemicals, instead utilizing advanced and stable mineral filters like non-nano zinc oxide. These alternatives provide excellent broad-spectrum protection without the associated risks of systemic absorption or endocrine disruption. This demonstrates that there is no technical or supply-chain barrier to implementing these vital public health protections.

The ASC and its members remain steadfast in our commitment to upholding the most stringent safety standards. By adopting these evidence-based reforms, we can ensure the public has access to the safest and most effective sunscreens possible, thereby maintaining trust in these essential therapeutic goods.

For a detailed breakdown of our scientific rationale, we invite you to view our submissions to the TGA.

The Australian Sunscreen Council is the peak body representing the Australian sunscreen industry, and our primary commitment is to advocate for scientifically rigorous standards that ensure the safety and efficacy of all sunscreen products available to the Australian public.