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Sunscreen standard 2012: information for industry
The TGA has made changes to how new sunscreen products are authorised for supply in Australia. This is in response to Standards Australia and Standards New Zealand updating the Australian/New Zealand Standard 2604 Sunscreen products - Evaluation and classification from AS/NZS 2604:1998 to AS/NZS 2604:2012.
- Sunscreens already supplied, which meet the 1998 Standard, will continue to be legal to supply and can only be labelled with a rating of up to SPF 30+.
- Sunscreens listed from 10 November 2012 will need to meet the 2012 Standard, which incorporates labelling with a rating of up to SPF 50+ and sets stringent requirements for the broad spectrum performance.
Australian regulatory guidelines for sunscreens have been developed, and replace Chapter 10 'Sunscreens' in the Australian regulatory guidelines for OTC medicines (ARGOM). These guidelines should be consulted for detailed information about sunscreen regulation in Australia, including changes related to the 2012 Standard.
The questions and answers below answer some key questions from sunscreen manufacturers and companies that supply sunscreens (sponsors) regulated by the TGA (therapeutic sunscreens).
From 10 November 2012 the TGA will be accepting notifications of sunscreens listed on the Australian Register of Therapeutic Goods (ARTG) that comply with the 2012 Standard. This is the date the 2012 Standard comes into force in the Therapeutic Goods Regulations 1990.
The two standards differ in:
- how high an SPF can be on the label
- the statistical requirements for the SPF and water resistance tests
- the broad spectrum test.
Sponsors and manufacturers are encouraged to read the Australian regulatory guidelines for sunscreens for more complete information.
Sunscreens that comply with the 1998 Sunscreen standard and are currently in the ARTG will be able to be marketed until they transition to using permitted indications. All currently listed medicines, including sunscreens, will have to be updated so that they only include permitted indications. This process requires sponsors to re-list their medicines; therefore, sponsors will need to ensure that their product complies with the current requirements. This means that all sunscreen products will need to comply with the 2012 Sunscreen standard.
The fee-free transition period ends on 6 March 2021. After this date, all listed medicines must only contain permitted indications. ARTG entries that have not transitioned to permitted indications will be cancelled.
Further information about permitted indications can be found on the Permitted indications for listed medicines web page.
No, in order for a current product to be given a new SPF number, it will need to be relisted on the ARTG with a new AUST L number.
The product would need to be retested for compliance with the requirements for broad spectrum performance using the test described in the 2012 Standard.
Please read the Australian regulatory guidelines for sunscreens for more complete information.
Sunscreens can be either 'primary sunscreens' (intended primarily for protection of the skin from the sun's UV radiation) or 'secondary sunscreens' (intended primarily for a purpose other than sun protection but also containing sunscreening agents).
In Australia, sunscreens fall into two categories for regulatory purposes, namely, 'therapeutic sunscreens' and 'cosmetic sunscreens', and are regulated as follows:
|Therapeutic sunscreens||Cosmetic sunscreens|
|Regulated by the TGA||
Excluded from regulation by the TGA. However:
Includes secondary sunscreens that are considered a 'cosmetic' and are included in the Therapeutic Goods (Excluded Goods) Determination 2018, namely: