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Australian regulatory guidelines for sunscreens (ARGS)
These Guidelines replace Chapter 10, 'Sunscreens', in the Australian Regulatory Guidelines for OTC Medicines (ARGOM) published in 2003. They have been produced by the Therapeutic Goods Administration (TGA) in consultation with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the pharmaceutical and cosmetics industries.
The first draft of these Guidelines was published on the TGA web site in May-June 2010 for stakeholder and public consultation. The preparation of the finalised Guidelines has taken into account the comments received as a result of the consultation and also the changes to the Australian and New Zealand Sunscreen Standard (see below).
These Guidelines describe the regulatory requirements and standards for sunscreens and their ingredients in Australia as at the date of publication.
Many of the terms, such as therapeutic sunscreen, cosmetic, cosmetic sunscreen, primary sunscreen, secondary sunscreen, sun protection factor (SPF) referred to in these Guidelines are defined in section 11 'Glossary of terms and abbreviations'.
The legislation (Acts and regulations), standards and other relevant regulatory documents (Therapeutic Goods Orders, codes, etc.), referred to in these Guidelines are listed along with their sources in section 12 'Bibliography' at the end of the document. Sunscreens classified as therapeutic goods are, unless exempt, required to be included in the Australian Register of Therapeutic Goods (ARTG) maintained by the TGA before they can legally be marketed in Australia. To be listed, sunscreens must comply with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products-Evaluation and classification in force at the time of listing.
A new Australian and New Zealand Sunscreen Standard, AS/NZS 2604:2012 which replaces the previous Standard AS/NZS 2604:1998 has been developed by the Standards Australia and Standards New Zealand in consultation with stakeholders and the public. This was published on 30 May 2012. The Standard and the International Standards Organisation (ISO) standards to which it refers are available for purchase from SAI Global through its web site.
AS/NZS 2604:2012 includes the following significant changes from the previous Standard:
- Adoption of the ISO 24444:2010 in vivo test procedure for determining SPF. This is essentially the same as the in vivo test procedure in AS/NZS 2604:1998, but includes statistical criteria for acceptance of the test results. In most cases the SPF test results obtained according to AS/NZS 2604:1998 would comply with ISO 2444:2010.
- Increase of the maximum SPF that may be claimed on the label of a sunscreen product from SPF 30+ to SPF 50+. A claim of SPF 50+ is allowed only if the mean SPF test result is 60 or higher.
- Limiting of the permitted SPF claims to 4, 6, 8, 10, 15, 20, 25, 30, 40, 50 and 50+ (depending on the SPF test result). Note that a claim of SPF 30+ is not permitted under AS/NZS 2604:2012.
- Changing of the SPF ranges for categorisation of protection as 'low' (SPF 4, 6, 8 or 10), 'medium' or 'moderate' (SPF 15, 20 or 25), 'high' (SPF 30, 40 or 50) or 'very high' (SPF 50+).
- Adoption of the in vitro test procedure in ISO 24443:2012 for determining broad spectrum performance. The criteria for broad spectrum performance determined using this test procedure are significantly more stringent than the criteria in AS/NZS 2604:1998, and many products complying with that standard would not comply with ISO 24443:2012.
- Making 'broad spectrum' performance mandatory for all primary sunscreens and for those secondary sunscreens classified as 'therapeutic sunscreens' and regulated by the TGA.
- Making 'broad spectrum' performance mandatory for cosmetic sunscreens with SPF30 or higher and optional for cosmetic sunscreens with SPF less than 30.
In recognition of this new Standard, Item 7 of Part 1 of Schedule 4, Item 8(g) of Schedule 5, and Item 14 of Schedule 7 of the Therapeutic Goods Regulations 1990 (the Regulations) have been amended to require sunscreens products listed in the ARTG as from 10 November 2012 to comply with AS/NZS 2604:2012 rather than AS/NZS 2604:1998.
However, regulation 49 of the Regulations allows products listed prior to that date (that come within Item 7 of part 1 of Schedule 4 or are able to be marketed in Australia because they are exempt under Item 8(g) of Schedule 5 of the Regulations) to continue to comply with AS/NZS 2604:1998.
Sponsors may make changes to those products (for example, changes to labels or sites of manufacture) provided the changes do not make the product a new product requiring a new listing in the ARTG.
A proposed change to a product will create a new product if it is of the kind referred to in s.16(1A) of the Act (different active ingredients, different quantities of active ingredients or different dosage form) or in regulation 11 of the Regulations (different name, different indications, different excipient or changes are made to or in relation to any restricted ingredients).
If a new listing is required because of such a change, the product concerned will need to comply fully with AS/NZS 2604:2012.
At the time the 2012 guidelines were published the majority of sunscreens listed in the ARTG carried claims of SPF30+ and provided broad spectrum protection.
An SPF30+ sunscreen may have originally produced an SPF test of 40 or higher and, therefore, could potentially carry a claim of SPF 40, SPF 50 or SPF 50+ allowed under AS/NZS 2604:2012. In most cases the SPF test results (and water resistance test, if relevant) obtained previously would have complied with the statistical requirements of AS/NZS 2604:2012 and retesting for these parameters would not be necessary. Any such product would, however, need to be retested according to AS/NZS 2604:2012 and ISO 24443:2012 for compliance with the requirements for 'broad spectrum' performance. If any such product passed the broad spectrum test, the product could be renamed and relabelled accordingly in compliance with AS/NZS 2604:2012. Prior to release into the Australian market it would need to be relisted in the ARTG as a new product with a new AUST L number.
If, on the other hand, the product failed the broad spectrum test in AS/NZS 2604:2012, it may be possible for it to be reformulated (for example, by adjusting the quantities of the active ingredients within the allowed limits or adding other approved active ingredients) in order to pass the test. The reformulated product would then need to be retested for SPF (and water resistance, if relevant), renamed and relabelled in full compliance with AS/NZS 2604:2012 and these Guidelines, and listed in the ARTG as a new product with a new AUST L number. Depending upon the degree of reformulation required, new stability data may also need to be generated to support the shelf life claimed for the reformulated product.