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.
- When will sponsors be allowed to list sunscreens on the ARTG that comply with the 2012 standard?
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.
- What are the main differences between the two standards?
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.
- Will sponsors still be able to supply sunscreens that comply with the 1998 standard?
Yes, sunscreens that comply with the 1998 Standard and are currently on the ARTG will be able to be marketed for as long as the sponsor wishes. This is permitted by Regulation 49.
Sponsors may also make changes to these products (e.g. changes to product names, labels or sites of manufacture), so long as these changes are not so fundamental that the product would require a new listing in the ARTG. If a new listing is required, then the 2012 Standard must be applied.
- Can sponsors change currently listed products to reflect a higher SPF?
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.
- What about cosmetics and moisturisers containing sunscreens?
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 sunscreening but also containing sunscreening agents.
In Australia, sunscreens fall into two categories for regulatory purposes, namely, "therapeutic sunscreens" and "cosmetic sunscreens", and are regulated by different government agencies as follows:
Therapeutic sunscreens Cosmetic sunscreens Regulated by the TGA Regulated by NICNAS (ingredients) and the ACCC (labelling)
- All "Primary sunscreens"
- "Secondary sunscreens" that are not "cosmetics" as described in Cosmetic Standard 2007 - mainly moisturisers containing sunscreen with an SPF greater than 15
- all sunscreens (SPF 4 or more) that contain an insect repellent
- sunscreens with ingredients that are from humans, or particular organs from:
- mule deer.
Includes secondary sunscreens that are "cosmetics" as described in the Cosmetic Standard 2007, namely:
- Moisturisers with sunscreen if SPF is 15 or less (pack size no more than 300 mL)
- Sunbathing products with SPF between 4 and 15 (pack size no more than 300 mL)
- Lip balms/lip sticks with sunscreen (any SPF)
- "Make-up" products with sunscreen (any SPF)