Consultation on a proposed exposure model for assessing the safety of sunscreen ingredients in Australia

Overview

The Therapeutic Goods Administration (TGA) is seeking public comment on proposed models to estimate sunscreen use (exposure) by Australians which will be used to calculate the maximum safe concentration of sunscreen ingredients.

The options proposed for stakeholder consideration include:

• Option 1: 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: Scientific Committee on Consumer Safety (SCCS) exposure model

This model is well-established and applied by some international regions such as Europe, where sunscreens are regulated as cosmetics. However, the estimated daily sunscreen exposure is derived from information and assumptions that may not reflect how sunscreen is used 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: Status quo

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.

Consultation paper

Consultation paper

Attachment 5 - ASEM Calculations Microsoft Excel file

Why your views matter

The TGA is seeking stakeholder feedback on the best way to estimate sunscreen use in Australia, as well as any positive and negative impacts the proposals may have on businesses, professionals, and consumers. The feedback will be used to help inform the Government’s decision on implementing an appropriate proposal.