Announcement date
24 January 2024
Link to announcement
Problem being addressed
Before a therapeutic sunscreen product can be marketed and supplied to consumers in Australia, the TGA must have approved the ingredients used in the product and established their maximum safe concentration. Determining the systemic exposure, and consequently, the safe concentration of the sunscreen ingredient, is based on how much sunscreen is applied to the skin on a daily basis (i.e. the sunscreen exposure amount). There is little contemporary data on how much sunscreen Australians apply to their skin and the amount used is variable and difficult to estimate. Further, individual sunscreen application varies based on factors such as daily habits, occupational exposure and recreational activities.
To date, TGA assessment for sunscreen ingredients has been through a variety of risk-based methodologies that may use different estimates of daily sunscreen exposure, on a case-by-case basis. The European Scientific Committee on Consumer Safety’s (SCCS) estimating exposure model is the main approach utilised by applicants in Australia. However, this model is based on data from research conducted in countries outside Australia. It is unlikely this approach is appropriate for the Australian context, given we have the highest rates of skin cancer in the world, a focus on public health messaging on the importance of using sunscreens, a thinner ozone layer and an outdoor lifestyle.
The absence of an agreed estimated daily sunscreen exposure value and assessment methodology means there is no standardised method for evaluating sunscreen ingredients, potentially leading to discrepancies in risk assessments. There are also increasing scientific concerns, both domestically and internationally, over long-term use of some current sunscreen ingredients. In combination, these issues have the potential to decrease consumer confidence in the use of sunscreens and cause regulatory uncertainty for industry.
Proposal
Three options are proposed for a method to calculate safe levels of new ingredients for use in Australian sunscreens:
- Option 1: Adopt the Australian Sunscreen Exposure Model (ASEM). This model calculates the estimated average daily sunscreen exposure based on the varied needs of Australians and integrates the expected sunscreen application practices that align with current Australian recommendations.
- Option 2: Adopt the Scientific Committee on Consumer Safety (SCCS) sunscreen exposure model which is a well-established approach that describes default estimated daily sunscreen exposure. This model is recognised in some international regions where sunscreens are regulated as cosmetics, such as Europe, and has been employed in previous sunscreen ingredient applications, and TGA assessments.
- Option 3: Do not adopt a specific estimated daily sunscreen exposure model, and continue to conduct evaluation of sunscreen ingredients on a case-by-case basis (that is, retain status quo).
Based on broad in-principle stakeholder support and the extent to which it is proposed to achieve the stated objectives, Option 1 is considered to be the option with the highest net benefit. The model underpinning Option 1 uses the most contemporary, evidence-based and realistic information and use cases, and is expected to uphold sunscreen safety and trust by consumers and provide regulatory certainty for industry.
Assessed Impact Analysis outcome
Good practice
Assessment comments
The analysis in the IA is good quality overall. The IA addresses the seven IA questions and follows an appropriate policy development process commensurate with the significance of the problem and magnitude of the proposed intervention. In particular, the IA clearly demonstrates the problem, why government intervention is required and considers a range of suitable policy options. To be considered ‘exemplary’ as per the Guide, the IA would have benefited from further analysis on the likely impacts on importers and exporters.
Regulatory burden
The TGA estimates the preferred option will result in a decrease to industry in average regulatory costs of -$32,817 per year, over ten years.