Clarification and updates to the regulation of sunscreens

Overview

The Therapeutic Goods Administration (TGA) is seeking public comment on potential clarification and updates to the regulation of sunscreens.

The potential regulatory clarification and updates include:

1. Adoption of the Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) which specifies the current testing and labelling requirements for sunscreens.
2. Removal of the category of ‘exempt’ sunscreens and previous transitional arrangements from the Therapeutic Goods Regulations 1990 (the Regulations) which enables sunscreen products with less than SPF4 (that were supplied in the market prior to 9 November 2012) to comply with the superseded Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:1998 (the 1998 Sunscreen Standard) and be exempt from the requirement to be included in the ARTG.
3. Clarification on the indications (therapeutic uses) that sunscreens can make. Three options are proposed for stakeholder consideration.

Consultation paper

Clarification and updates to the regulation of sunscreens - consultation paper

Why your views matter

The TGA is seeking stakeholder feedback on any positive or negative impacts the proposed amendments may have on business and/or consumers. This information will be used to help inform the Government's decision on whether or not to implement any of the proposals by amending the relevant legislation.