Clarification and updates to the regulation of sunscreens

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Closes 31 May 2023

Proposal 1: Adoption of the new sunscreen standard

Standards Australia have recently published the Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard), which replaces the Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:2012 (the 2012 Sunscreen Standard). The TGA is proposing to adopt the 2021 Sunscreen Standard by updating the therapeutic goods legislation to include references to this standard and removing references to all previous Sunscreen Standards.

Refer to the consultation paper for more detailed information on Proposal 1 before answering the consultation questions.

 

1. For sunscreen sponsors: Will adoption of the 2021 Sunscreen Standard, including adoption of the latest ISO testing methods have any significant impacts on your business?
2. For sunscreen sponsors: Is your business in a position to adopt the 2021 Standard earlier i.e., before it is adopted into legislation by the TGA?
3. For sunscreens sponsors: Do you agree that all new sunscreens will be required to comply with the 2021 standard from adoption commencement date?
4. For all stakeholders: Do you support a transition period of 3 years for sunscreens already in the market to comply with new testing requirements?
5. For all stakeholders: Do you support a transition period of 1 year for aerosol and pump pack sunscreens to comply with new labelling requirements?
6. For all stakeholders: Do you have any other comments or feedback about the proposed amendment to the Regulations and Excluded Goods Determination?