Australia Consults on a Proposed Exposure Model for Assessing the Safety of Sunscreen Ingredients

Background

Before a sunscreen product can be supplied to consumers in Australia, the Therapeutic Goods Administration (TGA)’s approval for its ingredients and their maximum safe concentration is essential. However, the risk assessments for sunscreen ingredients have traditionally been conducted on a case-by-case basis, relying on data provided by sponsors. Different approaches and international models have been employed, while some of these approaches may be conservative or not align with the Australian context. In addition, the variance in exposure calculation methods can result in regulatory inconsistencies and uncertainties for sponsors introducing new ingredients. In this context, a standardized, evidence-based approach is therefore needed to ensure regulatory consistency.

TGA’s Consultation on Proposed Models

Based on this, on July 2, 2024, the TGA initiated a public consultation on developing a standardized model to assess exposure to sunscreen ingredients. This will enable the TGA to calculate safe concentrations of sunscreen ingredients based on Australian conditions and the latest scientific information. The public consultation is open until August 13, 2024.

The consultation paper outlines three options for the sunscreen exposure model:

Option 1: Developing the Australian Sunscreen Exposure Model (ASEM)

The ASEM calculates the highest estimated daily sunscreen exposure, by integrating expected sunscreen application practices with current evidence-based Australian recommendations and research, rather than relying on international models. This approach ensures that risk assessments, when based on individuals that use a high amount of sunscreen, also ensure safety for individuals that use less sunscreen.

Option 2: Adopting the Scientific Committee on Consumer Safety (SCCS)’s exposure model

This model is well-established and applied by some international regions like Europe, where sunscreens are regulated as cosmetics. However, the estimated daily sunscreen exposure is derived from information and assumptions that may not reflect sunscreen usage in Australia. The TGA seeks to ensure that any model adopted is reflective of Australian sunscreen use and provides a realistic and safe framework for evaluating sunscreen ingredients.

Option 3: Maintaining the status quo and continuing to use existing methods

This option involves not adopting a specific sunscreen exposure model and continuing to evaluate sunscreen ingredients on a case-by-case basis using various approaches.