Our investigation of sunscreens includes requiring information from sponsors and providing them with a fair opportunity to respond before taking any regulatory action (if appropriate). Due to the complexity and scale of the information/data involved, this process takes time.
We encourage sponsors to remain up to date with any developments through the News and Community page of the TGA website.
Regulatory obligations
As a sponsor of a listed sunscreen, you are required to hold information or evidence to support any claims made about your sunscreen, such as an SPF claim, at all times. If you become aware of information that casts doubt on your claims, you should gather additional information (such as further SPF testing) promptly to ensure that you continue to hold evidence to support your claims.
What to do if you identify a problem with your sunscreen
If you identify a problem with your sunscreen, including a concern about its quality, safety, or efficacy, you should take the following steps:
- Assess the problem by gathering details of the affected product(s) and conducting a risk analysis.
- Submit a notification to the TGA through the TGA eBusiness Services (Business Services > Applications > Market actions). This notification should explain the problem and the proposed mitigation. Refer to the Procedure for recalls, product alerts and product corrections (PRAC) for more information.
A market action addresses problems with therapeutic goods supplied in the Australian market that have, or may potentially have, deficiencies relating to safety, quality, efficacy (performance), presentation or use.
Sponsors are expected to notify the TGA and wait until the TGA has reviewed and agreed to proposed market actions before contacting customers, consistent with the PRAC, to ensure that market actions are carried out appropriately.
You must ensure that your sunscreen’s ARTG entry meets all regulatory requirements. This may involve updating certain product details (e.g. the claimed SPF rating) to ensure that the ARTG entry remains accurate and supported by information/evidence you hold. Refer to the Guidance on changing information in the ARTG for more details.
Sponsors must report all serious adverse events and significant safety issues to us within the required timeframes detailed in the Pharmacovigilance responsibilities of medicine sponsors.
Guidance on how to select a reputable laboratory to conduct your SPF testing
As part of our investigations into SPF sunscreen testing it has come to our attention that some testing laboratories may be more reliable than others. The TGA has published advice to assist sponsors in choosing an appropriate laboratory to conduct their sunscreen SPF testing.
Will SPF test results from Princeton Consumer Research Corp (PCR Corp) be accepted?
As outlined in our Advice for Sunscreen Sponsors and Manufacturers: Acceptance of Additional SPF Testing Information, the TGA considers the reliability of an SPF testing laboratory when assessing whether its results accurately reflects a sunscreen’s SPF rating.
The TGA has significant concerns about the reliability of SPF testing undertaken by Princeton Consumer Research Corp (PCR Corp), a testing laboratory based in the United Kingdom. The TGA is aware that some sunscreen sponsors and manufacturers have relied on testing by PCR Corp to support their SPF claims, and that they obtained that testing before they were informed of the TGA’s concerns. The TGA will consider all evidence provided in support of a sunscreen’s SPF indication, including evidence from PCR Corp. However, the TGA will generally give less weight to evidence where the TGA has concerns about its reliability.
While we investigate this matter, sponsors are encouraged to review the guidance on assessing laboratory reliability and re-evaluate their SPF test results from PCR Corp. During a compliance review, the TGA may require sponsors to provide additional evidence supporting the SPF indication for their sunscreens, or scientific justifications to demonstrate that PCR Corp SPF test results can be relied upon to support an SPF indication. The TGA will then consider what regulatory action, if any, is appropriate in the circumstances.