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Recent developments in relation to the regulation of sunscreens have highlighted a degree of variability across test results generated under the current requirements for Sun Protection Factor (SPF) testing. This advice outlines the other types of SPF testing that can be provided to the TGA to support SPF claims. This advice also outlines what to consider when selecting a laboratory for SPF testing, including the accreditation the laboratory holds.
The TGA recommends that you consider this advice if you are a sponsor or manufacturer who is uncertain about the robustness or sufficiency of the evidence you hold for SPF performance, and you are selecting a laboratory for further SPF testing. In addition, the TGA recommends that you consider this advice at the time of initial product development or testing to ensure alignment with TGA expectations from the outset.
TGA evaluation of evidence
It is a legislative requirement that sponsors hold information or evidence that supports the SPF indications for their sunscreen at all times. The TGA may require sponsors to provide this information or evidence for review at any time while the sunscreen is included in the Australian Register of Therapeutic Goods (ARTG).
When assessing this evidence, the TGA will generally consider the testing standard used, the accreditation held by the testing laboratory and supporting documentation about the testing laboratory to determine the reliability of the evidence. Where multiple tests have produced different SPF results, these factors may be considered by the TGA when weighing the totality of evidence submitted for SPF indications. Sponsors should ensure that testing aligns with relevant standards and is supported by reliable evidence.
Please note that this advice does not set mandatory requirements. It sets out some factors that a TGA delegate will generally consider when assessing whether the SPF data held by a sponsor is sufficient to support the SPF indication. In this way, it provides an indication of what is more likely to result in a positive compliance finding by the TGA, with respect to existing legislative requirements.
Evidence supporting SPF indications
AS/NZS 2604:2021 Sunscreen products – Evaluation and classification (or the preceding version, AS/NZS 2604:2012, in some circumstances) (AS/NZS 2604) is currently the primary standard for SPF testing.
The requirement to hold testing conducted in accordance with AS/NZS 2604 is currently imposed under Item 7 of Schedule 4 of the Therapeutic Goods Regulations 1990. This means that Sponsors must establish the SPF for their sunscreens by testing in accordance with AS/NZS 2604 before they apply to list the sunscreen on the ARTG under s 26A of the Therapeutic Goods Act 1989. The TGA is reviewing this legislative requirement.
The TGA acknowledges the challenges with the current method and that reproducibility between laboratories is also a challenge. The current method recognised by AS/NZS 2604 specifically for SPF testing is ISO 24444. ISO is a globally recognised, independent, non-governmental body that develops and publishes international standards to ensure quality, safety, and efficiency across a wide range of industries, including cosmetics and sun protection. In December 2024 ISO published two new sunscreen testing methods:
- ISO 23675:2024 – Cosmetics – Sun protection test methods – In vitro determination of sun protection factor SPF
- ISO 23698 – Cosmetics – Measurement of the sunscreen efficacy by diffuse reflectance spectroscopy.
These methods were specifically developed to overcome the known challenges with ISO 24444, and validation data for these methods were published in early September 2025 in the International Journal of Cosmetic Science. The TGA finds this evidence for the suitability of these in-vitro methods for supporting SPF indications compelling.
The requirement to hold evidence in accordance with AS/NZS 2604 before listing a sunscreen on the ARTG does not prevent sponsors from obtaining or holding additional evidence to substantiate the SPF of their goods, including testing using in vitro methods against ISO 23675:2024 and ISO 23698:2024. It also does not prevent the TGA from considering this evidence or obtaining our own testing results using alternative methods, including in vitro methods.
Laboratory accreditation preferences
Addressing the challenges in SPF testing requires a multifaceted approach. While the development and adoption of more robust standards—such as the recent ISO methods—provide a solid scientific foundation for reproducible and reliable results, they alone cannot guarantee the integrity of testing outcomes. The selection of laboratories with proven expertise and appropriate accreditation is equally essential. Competent laboratories, operating within stringent quality frameworks, are better equipped to implement these standards effectively, minimise variability between test results, and ensure that claims about sunscreen efficacy are reliably supported. Thus, harmonising advanced standards with rigorous laboratory selection is vital for enhancing confidence in SPF test data and safeguarding public health.
The TGA understands that some SPF testing laboratories do not currently have accreditation to a testing standard, and that gaining this kind of accreditation is challenging.
This advice sets out how the TGA proposes to apply a tiered weighting system when evaluating SPF testing evidence. Data obtained from laboratories at the top of the list will generally be given more weight, as it will be considered more reliable and accurate. As such, sponsors are encouraged to select laboratories in the following order of preference – laboratories that have:
- AS ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories[1] (ISO/IEC 17025) accreditation with the sunscreen SPF testing method(s) explicitly included within the scope.
- ISO/IEC 17025 accreditation in the same field of testing (e.g., cosmetic or pharmaceutical testing).
- ISO/IEC 17025 accreditation in another field or Good Laboratory Practice certification.
- GMP certification or clearance not for sunscreen SPF testing.
- ISO 9001 accreditation.
- No formal accreditation but evidence as set out in the table below from the laboratory which supports the reliability of the testing.
- Laboratories with no accreditation and no evidence to demonstrate reliability.
Where a sponsor or manufacturer has used a laboratory that sits towards the bottom of the list, they should consider whether additional evidence or scientific justification should be obtained to support their SPF indication.
Engaging laboratories to ensure reliability of results
Sponsors and manufacturers are encouraged to engage with laboratories—regardless of accreditation status—to understand how they handle data that supports the reliability of their testing, even when that data is not required to be reported in Annex G of ISO 24444:2019 or Section 8 of ISO 24444:2010. The principles of this advice can also apply to testing with the new ISO methods. Sponsors and manufacturers could consider obtaining from the laboratory:
| Type of information | Description of information |
|---|---|
| Validation reports | This is strong evidence that the laboratory has specifically examined their ability to obtain correct results. For example, a report that addresses the requirements of ICH Topic Q 2 (R1) - Validation of analytical procedures: text and methodology. |
| Quality assurance (QA) documentation | Records of ongoing QA activities, audits, and reviews. |
| Evidence of data integrity | Evidence that the testing performed was specifically on your product, such as time and date stamps in photographs with your sample details included in a way that cannot be digitally manipulated. |
| Personnel training records | Evidence of staff training and competency for SPF testing methods. |
| Calibration and maintenance logs | Documentation for calibration and maintenance of equipment required for SPF testing, particularly the UV source. |
| Sample handling documents | Records ensuring traceability of sample handling during testing. |
| Proficiency testing records | Evidence of participation in inter-laboratory comparisons and proficiency programs (e.g. ring studies). |
| Corrective action documentation | Reports of corrective actions taken in response to any non-conformance. |
| Protocol review records | Evidence of regular review and updates to protocols in line with regulations. |
Transitional advice and future direction
This advice reflects some of the factors that the TGA will generally consider when reviewing sponsor SPF testing data, and in determining whether they meet existing legislative requirements. However, sponsors should be aware that the TGA is actively considering a future requirement that SPF testing evidence must come from laboratories meeting stringent accreditation/certification requirements.
[1] This accreditation should be from an International Laboratory Accreditation Cooperation (ILAC) signatory.