Broad spectrum protection: TGA releases consultation paper on the future of sunscreen regulation

On 26 March 2026, the Therapeutic Goods Administration (TGA) released a consultation paper (Consultation) seeking feedback on improvements to the regulation of sunscreens in Australia. The Consultation follows a period of heightened focus on sunscreen products by consumer advocacy groups, in the media and by the TGA, as reflected in the TGA's compliance principles for 2026 and 2027. The Consultation observes that developments in the sunscreen market, including in respect of "new novel"' sunscreen products with different dosage forms, SPF labelling inconsistencies and potentially variable and unreliable testing methods has caused the TGA to consider regulatory options to address these issues. Maintaining "consumer confidence" in sunscreen products is identified as a key driver in seeking to "improve the regulation of sunscreens" in the Consultation by the TGA.

The Consultation proposes various reform options (including retaining the status quo) and invites stakeholders to provide feedback on the future of sunscreen regulation in Australia. The TGA has invited submissions in response to the proposals outlined in the Consultation by 23 May 2026.

The consultation paper reflects proposals aimed at addressing challenges that the TGA has had when investigating sunscreen compliance. The TGA has noted that compliance with the current framework relies on sponsor certifications and that any resulting post market compliance monitoring is resource intensive and time consuming.

SPF testing

The Consultation proposes certain reform options to address the following interrelated challenges with the current approach to SPF testing in Australia.

Variability of SPF testing

The TGA acknowledges there is "significant variability" in results obtained using the current in vivo (human) testing method prescribed under the current ISO standards. The Consultation explores proposals that would permit sponsors to use newer in vitro (laboratory-based) testing methods, or the use of in vitro methods alongside in vivo testing or mandating in vitro testing where appropriate. While the Consultation does not preference a reform option, it does recognise the in vitro method as "more cost-effective and efficient for industry" and may potentially resolve the variability and reproducibility issues and describes the current in vivo method is "invasive" and may pose "ethical concerns associated with exposing people to UV radiation".

Limited TGA oversight of testing

Currently, the TGA does not have oversight of which testing laboratory is used by sponsors for SPF testing, nor does it regulate or accredit SPF testing facilities or providers. Further, under the current regulatory framework, laboratories testing sunscreens are not required to hold a Good Manufacturing Practice (GMP) licence, certification or clearance. The onus of responsibility for selecting an appropriate testing laboratory remains with the sponsor of the sunscreen product. The Consultation suggests that the "low reliability" of certain laboratories may have permitted the listing and supply of sunscreen products that do not provide the claimed SPF protection.

To address this, the Consultation identifies a reform proposal to require that SPF testing be performed by an accredited or certified laboratory which would hold GMP licences. However, the Consultation observes that few laboratories globally hold the proposed accreditations required, which may lead to testing bottlenecks and higher testing costs. This proposed option would require further TGA resources to conduct audits of accredited or certified laboratories. While the Consultation seeks feedback on this option and the status quo option, noting the concern expressed in respect of addressing variability in the test methods to improve the reliability of SPF test results and the need to monitor the performance of the laboratories conducting these tests, reforms may arise in this area.

Flexibility to adopt new testing standards

Currently, sunscreens must meet the requirements of a specific Australian Standard mandated by the Therapeutic Goods Act (TG Act). This limits the TGA's ability to make changes to testing requirements (because changes require Parliament to amend the legislation). The TGA is considering alternative regulatory approaches, including a dedicated legislative instrument that could be amended in response to updated scientific standards, enabling alignment with international standards of sunscreen testing, fostering a greater degree of regulatory harmonisation for sponsors.

Sponsor evidence to support SPF claims

The TGA has identified instances where a sunscreen's formulation has been modified throughout its lifecycle without additional SPF testing being conducted, which has exposed several regulatory issues. SPF testing on base formulations during the development phase is permitted, with sponsors not required to conduct ongoing testing of commercially released batches or to demonstrate shelf-life performance for any SPF claims. This has resulted in a scenario where some sponsors have not conducted new SPF testing even when a formulation may no longer be representative of the supplied product.

The Consultation proposes options to address this issue, including enhanced guidance on when additional testing is expected, as well as permitting minor formulation changes without mandatory retesting. The Consultation also considers mandating SPF testing at specified times in a product's lifecycle. These reform options appear to respond to the concerns raised by the TGA in the Consultation about the need to strengthen public confidence in SPF claims. The primacy of these policy aims articulated in the Consultation would suggest there is a stronger prospect of reform to address these issues.

Provision of SPF testing data

Currently, sponsors are not required to provide SPF testing data to the TGA when applying to list a sunscreen on the Australian Register of Therapeutic Goods (ARTG), or to otherwise make testing data publicly available. The TGA proposes addressing this issue by requiring sponsors to either provide their testing data to the TGA at the time of listing the product on the ARTG which is to be held in confidence, or requiring sponsors to make their testing data publicly available. While noting the importance of transparency, in respect of the latter option, the TGA notes there may be confidentiality and intellectual property concerns with the complete disclosure of testing data. Provision of the testing data to the TGA on a confidential basis would, in contrast, permit the TGA to test the SPF data to verify any claims made in connection with the product. Noting the clear imperative articulated by the TGA in the Consultation for verifying SPF claims, reforms may arise in this area.

Other quality and labelling considerations

Potential quality issues concerning specific formulations or ingredients

The Consultation identifies a paucity of regulation with respect to ingredient and quality standards for sunscreens. The Consultation proposes options to address this issue including the development of instruments that mandate ingredient-level quality standards or requiring pre-market evaluation for safety, quality and efficacy for all sunscreens under a registered products model. If pre-market registration were adopted, this would represent a fundamental shift in how sunscreens are brought to market in Australia. This approach could add cost and time for sponsors and the TGA in bringing new products to market.

SPF labelling considerations

The Consultation notes that consumers may not adequately understand what SPF values mean in real terms due to the various factors that can impact the effectiveness of sunscreen against solar radiation. The variability of in vivo test results compounds this issue, making it difficult for sponsors to determine an accurate SPF value with confidence. The Consultation presents options to address this, including introducing additional labelling requirements for SPF rating or changing labelling requirements for sunscreen performance ratings with descriptive categories, "low", "medium", "high" and "very high", potentially supplemented with an easily identifiable graphic. The TGA acknowledges any changes to SPF labelling would involve a cost as sponsors would be required to update packaging.

Cosmetic sunscreens and high SPF claims

Under the current Therapeutic Goods (Excluded Goods) Determination 2018 (Cth), certain cosmetic products, such as tinted foundations and lip products, can make claims that they contain up to SPF 50+ without being subject to the same regulatory oversight applying to therapeutic sunscreens. The TGA notes that some consumers may use these products as primary sunscreens based on their high SPF claims, notwithstanding that these products are not typically used in the same way as a traditional sunscreen and are not subject to equivalent testing requirements. In this context, the TGA identifies a "safety and compliance gap" in the cosmetic sunscreens market.

The TGA proposes two options to address this issue including requiring excluded sunscreens to include "cosmetic sunscreen" on their primary label to improve transparency and consumer choice.

Alternatively, the Excluded Goods Determination could be amended to impose a consistent limit on the SPF rating that can be claimed for all secondary (cosmetic) sunscreens, restricting excluded secondary sunscreens to "low" SPF claims only such that those cosmetic products making higher SPF claims would need ARTG registration.

Opportunities to enhance sunscreen manufacturing guidance

 While noting that the TGA's recent investigation did not uncover any specific manufacturing issue which would account for the low SPF results at a systemic level, the opportunity to update the GMP guidance for sunscreens would be a positive development noting the current version was published in 2018 and predates several recent technical developments. Greater clarity with respect to risk management, definition and control of critical quality attributes and critical process parameters, responsibilities between manufacturers and sponsors, as well as responsibilities for product release would likely enhance the quality of the guidance provided to sunscreen manufacturers.

The TGA proposes undertaking an "open review" of GMP guidance to incorporate contemporary information and address any additional manufacturing risks. The TGA acknowledges that updated guidance may present additional regulatory burden for manufacturers and sponsors. However, noting the age of the current GMP guidance, we consider it to be likely that the current GMP guidance may be updated in the manner envisaged by the TGA.