Australian regulatory guidelines for sunscreens (ARGS)

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Version 1.1

22 January 2016

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

Updated to reflect the changes to the Therapeutic Goods Regulations 1990 by removing references to sunscreens with a claimed SPF of <4 that contain certain human or animal derived ingredients.

Updated the relevant sections by including reference to the recently made Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015.

Updated the table listing the permitted active ingredients by adding the newly approved sunscreen active Tris-biphenyl triazine.

Complementary and Over the counter Medicines Branch
OTC Medicines Evaluation

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