Announcement date
11 April 2024
Link to announcement
Updates to the Sunscreen Standard
Problem being addressed
Standards Australia is the nation's peak non-government standards organisation that develops internationally aligned Australian Standards (AS). AS are voluntary documents that set out specifications, procedures and guidelines that aim to ensure products, services, and systems are safe, consistent, and reliable. However, the Australian and State and Territory governments can mandate a standard by referring to an AS or joint Australian/New Zealand Standards in their legislation (AS/NZS). In December 2022, Standards Australia published the Australian/New Zealand Standard: Sunscreen products – Evaluation and classification (AS/NZS 2604:2021) (amended) (the 2021 Sunscreen Standard), which replaces the 2012 Sunscreen Standard.
Proposal
The Therapeutic Goods Administration (TGA) is proposing to adopt the 2021 Sunscreen Standard by removing references to the AS/NZS 2604:1998 (the 1998 Sunscreen Standard) and AS/NZS 2604:2012 (the 2012 Sunscreen Standard), and replacing these with references to the 2021 Sunscreen Standard in the following therapeutic goods legislation:
- Item 7 of Schedule 4 to the Therapeutic Goods Regulations 1990
- Items 14 and 15 of Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018
- Items 5 and 10 of Schedule 2 to the Therapeutic Goods (Excluded Goods) Determination 2018
Assessed Impact Analysis outcome
Adequate
Assessment comments
To achieve good practice as per the Australian Government Guide to Policy Impact Analysis, the IA needed to provide further detail of the likely costs and benefits to stakeholders (particularly with respect to the health benefits that consumers may experience) from the new standards. IA would also have benefitted from further detailing the Government’s objectives, barriers to meeting those objectives, outlining strategies to mitigate this risk and how the evaluation plan would evaluate the effectiveness of the new standards.
Regulatory burden
The TGA estimates that the preferred option would result in an average annual regulatory cost of $7,376,343 for all products, averaged over 10 years.