Australian regulatory guidelines for sunscreens (ARGS)
Version 1.0
13 November 2012
Contents
- 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:
- TGA
- 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 history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Office of Medicines Authorisation | 10/10/2012 |
About the Therapeutic Goods Administration
- 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.
Copyright
© Commonwealth of Australia 2012
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted under the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.
Web page last updated: Thursday, 22 November 2012
URL: http://www.tga.gov.au/industry/sunscreens-args.htm