Australia’s medicine regulator wants to get rid of SPF numbers, as part of a major industry shake-up.
The rating retirement is one change sought by the Therapeutic Goods Administration (TGA) as part of an overhaul of regulations relating to sunscreen and SPF products.
The regulator has opened public consultation on the current regulatory framework – including proposed changes to SPF testing requirements, oversight of the laboratories that test SPF levels, and how SPF products are labelled.
One major change would bring the end of familiar SPF numbers – replacing current ratings such as SPF50+ with low, medium, high and very high categories. The TGA says the move would simplify SPF labelling.
The regulator says the revamp is necessary because Australia “has the highest rates of skin cancer and melanoma in the world, with around 2000 people dying each year, it is critical that the regulatory settings are appropriate to ensure consumer confidence in sunscreens”.
The review comes as a result of the agency monitoring international and domestic sunscreen developments, which it says have “highlighted a number of matters”.
Because New Zealand follows the same sunscreen standards as Australia, the changes could have implications for products sold locally.
A Ministry of Health spokesperson said changes to Australian regulation will not have any direct impact on New Zealand.
“Whether the reforms proposed in Australia are implemented here will depend on various factors, including whether they are adopted in Australia.
“All sunscreens sold in New Zealand must go through consistent and internationally recognised testing of the product performance and labelling requirements.”
Commerce Commission head of fair trading and product safety investigations, Simon Pope, said the Sunscreen (PSS) Act requires that products sold and marketed locally meet the requirements of AS/NZS2604:2012 joint standard.
He said under the Fair Trading Act, breaches can result in a maximum fine of $600,000 per offence.
Last year, an Australian study found more than half of sunscreens tested didn’t reach their SPF claims – including 11 products sold in New Zealand.
Pope said manufacturers and importers are required to have their products independently tested to ensure they comply with the current Safety Standard before being supplied in New Zealand.
“We are aware that in the past, there have been instances of allegations of some products sold in New Zealand having SPF protection that was significantly less than claimed,” Pope said.
He said the commission was committed to looking into these allegations and would investigate where necessary.
Australian consumer group Choice, which first reported those SPF inconsistencies, mostly praised the proposed changes.
“Proposals to improve and expand testing requirements, require accreditation for testing laboratories, and increase transparency will help restore consumer trust in the reliability of SPF claims,” director of campaigns Andy Kelly told the ABC.
However, Kelly cautioned against abandoning the current numerical SPF rating system, which was highly familiar to consumers.
At present, sunscreens in Australia are regulated as either cosmetics or therapeutic goods depending on their ingredients, therapeutic claims and claimed SPF.
The TGA said SPF testing data from certain laboratories appeared unreliable and some product owners and manufacturers lacked an understanding about their legal obligations, leading to a “lack of robust oversight and standardisation in SPF testing”.
The Commerce Commission has successfully prosecuted sunscreen manufacturers for making unsubstantiated claims about the efficacy of their products, the ministry spokesperson said.
In 2022, Ego Pharmaceuticals Pty Ltd was fined $280,000 after pleading guilty to two representative charges under the Fair Trading Act 1986 for making unsubstantiated representations regarding the SPF of two sunscreen products.
The Government has indicated that sunscreen regulation may be considered as part of broader future reforms.
It is intended that any replacement will ensure that sunscreens on the New Zealand market meet appropriate standards, enable effective action to be taken when standards are not met, enable those standards to be updated in a timely way and align with Australia where appropriate.
In New Zealand sunscreen is regulated under the Sunscreen (Product Safety Standard) Act 2022 and must meet the Australian and New Zealand sunscreen standard.
Pope said the regulatory changes proposed by the TGA would not necessarily impact the regulation of sunscreens supplied in New Zealand.
Public consultation on the proposals is open until May 23. If accepted, options presented in the proposal paper would be implemented in “a proportionate and targeted manner, with appropriate transition periods incorporated”.