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Australian regulatory guidelines for sunscreens (ARGS)
3. Regulatory categories of sunscreens
This guideline is currently under review.
Most therapeutic sunscreens marketed in Australia are currently defined as 'listable' therapeutic goods which means that they must be 'listed' in the ARTG. Other sunscreen products must be 'registered' in the ARTG, while others are exempt from registration or listing (see below). General information on listing and registration of therapeutic goods is available on the TGA Internet site. The current regulation of the various categories of sunscreens is summarised in Table 1 and explained in the text that follows.
|Product category||Sub-category||Currently regulated by:|
||Listing in the ARTG under s.26A of the Act|
Sunscreens that make therapeutic claims other than sunscreening and/or reduction of risk of skin cancer, solar keratosis, sunspots or premature ageing.
(See subsection 3.3)
|Registration in the ARTG under s.25 of the Act|
Primary sunscreens with an SPF less than 4 and not containing ingredients of human or animal origin.
|Exempt from the requirement of listing or registration in the ARTG|
Some secondary sunscreens that are excluded from regulation by the TGA but meet the definition of a cosmetic.
(See subsection 2.2)
|Regulated by NICNAS and the ACCC as cosmetics and not regulated under the Act|
3.1 Exempt sunscreens
A therapeutic sunscreen product is 'exempt' under Item 8(g) of Schedule 5 of the Regulations if:
- the SPF established by testing according to AS/NZS 2604:2012 is less than 4, and
- the label claims comply with AS/NZS 2604:2012, and
- the product does not have an indication for the treatment of a serious disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code.
Exempt therapeutic sunscreens do not require registration or listing in the ARTG, but are treated as therapeutic goods in all other respects and must comply with all relevant parts of the Therapeutic Goods legislation, including relevant standards such as the Labelling Order (Therapeutic Goods Order No. 69, and amendments) and the Therapeutic Goods Advertising Code.
3.2 Listing of therapeutic sunscreens
The majority of therapeutic sunscreen products require listing in the ARTG in accordance with Item 7 of Part 1 of Schedule 4 of the Regulations.
Information on the listing process using the TGA's Electronic Listing Facility (ELF) and details of what information needs to be provided for listed products are provided in the Electronic Listing Facility (ELF) User Guide.
Under Item 7 of Part 1 of Schedule 4 of the Regulations, sunscreen products are eligible for listing where they come within the following description:
- 'Sunscreen preparations for dermal application (other than preparations for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code), if:
- the claimed sun protection factor has been established by testing according to the method described in Standard AS/NZS 2604:2012, as in force from time to time; and
- the performance statements and markings on the label comply with that Standard; and
- the sunscreen preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and
- if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the sunscreen preparation - none of the requirements have been contravened
The SPF of therapeutic sunscreens must be determined by testing on human skin in accordance with the sunscreen standard AS/NZS 2604:2012 which references the International Organisation for Standardisation procedure ISO 24444:2010 Cosmetics - Sun Protection test methods - In vivo determination of SPF (Sun Protection Factor).
Note that, where in vivo SPF test results have been produced using the US FDA static SPF test procedure described in FDA Sunscreen Drug Products for OTC Human Use: Final Monograph, the individual SPF results may be used to calculate the mean SPF and the label SPF provided they meet the statistical criteria set out in ISO 24444:2010 as referenced in AS/NZS 2604:2012.
Therapeutic sunscreen products may only contain active sunscreening ingredients that are included in the list of sunscreening agents permitted as active ingredients in therapeutic sunscreens (see subsection 9.1) and are within the maximum concentrations stated in the list.
Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure that the finished product is safe for its intended purpose.
Sunscreen products that make therapeutic claims other than sunscreening (for example, reduction of free radicals in or below the skin, or claims relating to reduction of UV induced immune suppression) and/or contain active therapeutic ingredients that are not included in the list of sunscreening agents permitted as active ingredients (see subsection 9.1) are not 'listable sunscreen preparations' and must be registered in the ARTG as OTC or prescription medicines depending on the active ingredients contained and therapeutic claims made (see subsection 3.3 for registration of therapeutic sunscreens). Subsection 4.1 lists the therapeutic claims permitted for listed sunscreens.
3.3 Registration of therapeutic sunscreens
Sunscreens that are not 'listable', 'exempt' or 'cosmetic' (excluded) are evaluated by the TGA for quality, safety and efficacy as registered therapeutic goods under section 25 of the Act.
Data to support the quality, safety and efficacy of such products are required as detailed under the relevant chapters of the Australian Regulatory Guidelines for OTC Medicines (ARGOM).
Products in this category include:
- products that contain a sunscreen active ingredient that is not included in the list of sunscreening agents permitted as active ingredients (see subsection 9.1)
- products that make any therapeutic claims other than the sunscreening claims permitted under section 4 'Labelling and advertising', or that are for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 of the Therapeutic Goods Advertising Code
- products that contain substances that are scheduled in the SUSMP
- products that contain a sunscreening active ingredient combined with a claimed therapeutic active ingredient that is not a permissible active ingredient in a listed medicine in accordance with section 26BB of the Act
- products that are not otherwise 'listable', 'exempt' or 'excluded'.
3.4 Responsibility of sponsors to report adverse reactions
It is a standard condition of listing or registration of a medicine that the sponsor has an appropriate system of pharmacovigilance and that the sponsor reports to the TGA adverse reactions experienced by users of the sponsor's products. This requirement applies to sponsors of therapeutic sunscreens.
Details of the TGA's requirements for pharmacovigilance and the reporting of adverse reactions can be found on the TGA Internet site.