Australia tightens sunscreen regulations following efficacy concerns
The TGA advises people in Australia to use sunscreen with an SPF of 30 or higher to help protect their skin from sun damage.
AUSTRALIA – Australia is advancing a series of reforms intended to strengthen sunscreen regulation and increase public confidence in sun-protection factor (SPF) claims.
The country’s Therapeutic Goods Administration (TGA) is progressing amendments covering SPF claims and their substantiation, with the aim of ensuring that consumers can rely on the protection levels stated on sunscreen products.
The reforms follow a period of public consultation and are designed to reinforce confidence in sunscreen performance while ensuring that product sponsors and manufacturers clearly understand their regulatory obligations.
The regulatory changes are being developed after a consumer advocacy investigation raised concerns about the accuracy of SPF claims.
Last summer, Choice found inconsistencies between some sunscreens’ advertised SPF ratings and their tested performance, prompting wider scrutiny of the industry and subsequent reviews and investigations by the TGA.
Choice tested 20 popular sunscreens in accredited laboratories and reported that 16 of the 20 products did not meet their claimed SPF levels.
One of the poorest performers was Ultra Violette’s Lean Screen SPF 50+ Mattifying Zinc sunscreen, which returned SPF values of four and five in two separate tests. Following repeated testing that produced widely inconsistent results, the brand withdrew the product from sale.
According to TGA, the existing regulatory framework for sunscreens may be outdated, particularly as both domestic and international SPF regulatory environments have evolved over time.
The reforms are intended to address these weaknesses by making SPF testing more reliable and by improving accountability across the supply chain.
Under the proposed changes, sunscreen testing requirements will be strengthened to improve the reliability of SPF claims.
These measures will be introduced in stages and may include allowing sponsors to use either in vitro or in vivo testing methods where appropriate.
Testing laboratories will also receive enhanced support for accreditation, while legislation will directly reference standards set by the International Organization for Standardization (ISO).
The reforms will additionally require SPF testing at the finished-product stage and periodically while a sunscreen remains listed on the Australian Register of Therapeutic Goods.
Sponsors will be required to provide testing data to the TGA when listing a product.
The TGA also plans to restrict the SPF claims that cosmetic sunscreens can make.
This measure is intended to create a clearer distinction between primary-purpose sunscreens, which are designed mainly to protect against UV radiation, and secondary or cosmetic sunscreens, where sun protection is not the principal function.
The regulator will further develop quality requirements for specific sunscreen ingredients to help ensure that products containing them are of high quality and perform as expected.
It will also review sunscreen good manufacturing practice guidance to reinforce expectations and clarify the responsibilities of manufacturers.
The reforms come at a time when Australia reports the highest rates of skin cancer in the world, with approximately two in three Australians expected to be diagnosed with some form of skin cancer before the age of 70.
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