What role does the Therapeutic Goods Administration play in the regulation of sunscreens?
The Therapeutic Goods Act became law in Australia in 1989. Around the same time, the former medicine and device regulator known as the National Biological Standards Laboratory became the Therapeutic Goods Administration (TGA) and was charged with the implementation and compliance with the new Act.
There were several changes made over a few years as to how and which products were deemed to be medicines.
Originally sunscreens with an SPF value of more than 4 were deemed to be medicines and, with some exceptions, were required to be listed as medicines on the Australian Register of Therapeutic Goods (ARTG).
Later years saw the raising of the criteria to SPF15 with certain qualifying conditions. The primary purpose of the ARTG listing is to ensure that all products offered for sale are safe and effective.
The early applications for the inclusion of a medicine listing were paper based but are now almost exclusively electronic. Electronic lodgement has made the applications much more accurate due to online validation.
As part of the compliance program, the listing process ensures that sunscreens only use approved ingredients in approved concentrations and that each product has been tested to ensure it meets its label claim.
There are also requirements to disclose certain ingredients that may be irritant or to be unacceptable to some individuals. The process also dictates which claims may be made and they provide mandatory warning statements for each product type.
In a separate role, the TGA controls the advertising of therapeutic goods to ensure that products do not make misleading claims about their effectiveness or safety.
Sponsors are often issued with warning notices for non-conformance and may be advised of a mandatory recall if it is determined that the product is potentially unsafe.
TGA approved sunscreen ingredients
At the point of applying for a marketing authority in the form of an ARTG listing, each ingredient must be entered into an electronic register.
The register then checks to see that the ingredient is allowable in Australia and that it is included in the product at the right concentration.
Any ingredient that has not been included on the register or is included at the incorrect concentration is rejected.
The approval process for ingredients includes a scientific study by experts to ensure that the product is safe and effective for its intended purpose.
TGA sunscreen requirements
Once again safety and efficacy are the primary requirements but there are many other conditions that apply to finished goods.
For example, they must have had sufficient stability testing to ensure that the product is robust under certain storage conditions.
They must be tested for chemical and microbial compliance before release for sale and the labelling must meet with current guidelines.
In addition, label claims must be compliant with the current Therapeutic Goods Advertising Code. In particular, the product must only contain claims that are scientifically verifiable and not misleading.
TGA sunscreen testing
Every sunscreen offered for sale in Australia must be tested to ensure that it meets its label claim.
The current testing requirement is that it must meet the current Australian Standard for the Determination of SPF value.
The standard sets down the testing protocol for SPF determination which involves actual human skin testing across a statistical number of volunteers.
The results of the trials determine what label claims may be made. The standard also sets out the testing criteria for water resistance and broad spectrum claims.
TGA sunscreen regulations
Sunscreens are regulated in accordance with the Australian Regulatory Guidelines for Sunscreens (ARGS) as currently in force.
The ARGS sets down the minimum requirements for the testing labelling and manufacture of sunscreens in Australia.
References:
- https://www.legislation.gov.au/Details/C2021
- https://www.tga.gov.au/australian-register-therapeutic-goods
- https://www.tga.gov.au/publication/sunscreen-manufacturing
- https://www.tga.gov.au/therapeutic-goods-advertising-code
- https://www.tga.gov.au/resource/australian-regulatory-guidelines-sunscreens-args
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