Australian regulatory guidelines for sunscreens (ARGS)
13 November 2012
- 1. Introduction
- 2. Therapeutic sunscreen or cosmetic sunscreen?
- 3. Regulatory categories of sunscreens
- 4. Labelling and advertising
- 5. Reproducibility of SPF test results
- 6. Changes to sunscreens
- 7. Stability testing
- 8. Manufacture and quality control
- 9. Permitted ingredients
- 10. New ingredients
- 11. Glossary of terms and abbreviations
- 12. Bibliography
- Appendix 1: Labelling checklist
The Australian regulatory guidelines for sunscreens (ARGS) have been developed to provide guidance to sponsors and manufacturers, and to assist in the understanding of the regulatory requirements for sunscreens in Australia.
The Australian Regulatory Guidelines for Sunscreens include information about:
- the different types of sunscreens
- which regulatory organisation regulates which type of sunscreen:
- National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Australian Competition and Consumer Commission (ACCC)
- the differences between the 2012 sunscreen Standard AS/NZS 2604:2012 and the 1998 Standard
- when therapeutic sunscreens are allowed to comply with the 1998 Standard, and when they need to comply with the 2012 Standard
- other regulatory requirements for sunscreens regulated by the TGA.
The TGA developed these guidelines in consultation with NICNAS, Accord Australasia, Australian Self-Medication Industry Inc (ASMI) and the Advisory Committee on Non-prescription Medicines (ACNM). A public consultation was also conducted.
The ARGS replaces Chapter 10 'Sunscreens' in the Australian regulatory guidelines for OTC medicines (ARGOM).
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Office of Medicines Authorisation||10/10/2012|
- The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
- The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
- The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
- The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
- To report a problem with a medicine or medical device, please see the information on Reporting problems on the TGA website.
© Commonwealth of Australia 2012
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Web page last updated: Thursday, 22 November 2012