Australia Adopts Updated Sunscreen Standards

On April 11, 2024, Australia’s Therapeutic Goods Administration (TGA) issued a notice announcing the adoption of the Australian/New Zealand Standard: Sunscreen Products – Evaluation and Classification (AS/NZS 2604:2021) (the “2021 Sunscreen Standard”) into therapeutic goods legislation framework.

Published by Standards Australia in 2021, the 2021 Sunscreen Standard supersedes the previous 2012 version and outlines comprehensive testing and labeling requirements for sunscreens available in the Australian market. Notable changes compared to its predecessor include:

• Incorporation of the latest ISO Standards for sunscreen testing, including “ISO 24444:2019 Cosmetics—Sun Protection Test Methods—In Vivo Determination of the Sun Protection Factor (SPF),” “ISO Standard 24443:2021 Determination of Sunscreen UVA Photoprotection in Vitro,” and “ISO 16217:2020 Cosmetics—Water Immersion Procedure for the Determination of Water Resistance.”

• Introduction of a new flow chart to guide sponsors (product owners) in determining the applicable sections of the standard for primary and secondary sunscreens.

• Addition of labeling instructions for aerosol and spray pump pack sunscreens, advising consumers on the appropriate amount for effective protection against UV radiation, and cautioning against spraying these products on the face or in windy conditions to avoid product inhalation.

Alongside this adoption, the TGA also released transition arrangements.

• Beginning July 1, 2024, all new sunscreen products included in the Australian Register of Therapeutic Goods (ARTG) must be compliant to the 2021 Sunscreen Standard.

• Existing aerosols and spray pump packs included in the ARTG before July 1, 2024 will be granted a one-year transition period to comply with the new labelling requirements outlined in the 2021 Sunscreen Standard.

• For all existing sunscreen products (both aerosol and non-aerosol) listed in the ARTG before July 1, 2024, a five-year transition period is provided. During this period, compliance with the testing requirements in either the 2021 Sunscreen Standard or the previous standard is acceptable.

• Upon conclusion of the transition period, all existing sunscreen products listed in the ARTG and any new products introduced for supply must be in line with the 2021 Sunscreen Standard.