Australian Sunscreen Council Holds Successful Federal Health Minister Meetings as TGA Advances 4-MBC Sunscreen Restrictions
The Australian Sunscreen Council has strengthened its role in national sunscreen safety policy following successful meetings with Federal Health representatives during the week commencing 7 September 2026, where Australian Sunscreen Council Director Joseph Mizikovsky presented evidence on 4-MBC & Homosalate safety concerns, Therapeutic Goods Administration sunscreen regulation and the importance of supporting Australian Made Zinc Sunscreen. ((9) Post | LinkedIn)
Mizikovsky met with the office of Federal Minister for Health and Ageing Mark Butler and with Dan Repacholi MP, Federal Member for Hunter and Australia’s Special Envoy for Men’s Health, to discuss stronger sunscreen ingredient safety standards, internal Therapeutic Goods Administration documents obtained by the Australian Sunscreen Council, and Australia’s opportunity to become a global leader in safe mineral sunscreen manufacturing. Minister Butler currently holds responsibility for the federal Health and Ageing portfolio, while Repacholi serves within the health portfolio as Special Envoy for Men’s Health. (Australian Government Department of Health, Disability and Ageing).((9) Post | LinkedIn)
A major focus of the meetings was 4-Methylbenzylidene Camphor (4-MBC), a chemical UV filter that the Australian Sunscreen Council has campaigned on for three years. Later that same week, on 11 September 2026, the Therapeutic Goods Administration opened a national public consultation on additional regulatory controls for 4-MBC following completion of its safety review. The consultation includes three scheduling options put forward by the Therapeutic Goods Administration Delegate and two private applicants. (Therapeutic Goods Administration, 11 September 2026). (TGA to consult on additional controls for an active sunscreen ingredient | Therapeutic Goods Administration (TGA))
For the Australian Sunscreen Council, the development represents an important milestone in a sustained campaign to strengthen Australian sunscreen safety while supporting an Australian industry already capable of producing world-class zinc oxide and mineral sunscreens domestically.
Three years of work to put 4-MBC on the national agenda
The Australian Sunscreen Council and its representatives have repeatedly raised concerns about 4-MBC with the Therapeutic Goods Administration, published internal regulatory documents obtained through Freedom of Information, supported media investigations into its continued use in children's sunscreens, documented international restrictions and called for the ingredient to be removed from Australian products.
An internal Therapeutic Goods Administration email released under Freedom of Information records that officials were being asked as early as 2024 whether the safety review of 4-MBC could be prioritised in response to continuing enquiries and complaints. (FOI 25-0017)
The Therapeutic Goods Administration has now completed that safety review. It concluded that regulatory controls are warranted to restrict the permitted concentration and use of 4-MBC in therapeutic sunscreens. The regulator identified systemic absorption and potential toxicity as the two central issues assessed and applied its Australian Sunscreen Exposure Model in reaching its conclusions. (Consultation: Proposed amendments to the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC) - Joint ACMS-ACCS meetings - November 2026 | Therapeutic Goods Administration (TGA))
The Australian Sunscreen Council has also conducted an international regulatory review showing that 4-MBC is now prohibited, excluded or not approved for sunscreen use across a large number of international markets. Its August 2026 analysis identified 95 countries, as well as 31 overseas territories, where 4-MBC is prohibited or excluded under the applicable regulatory framework.(https://www.australiansunscreencouncil.org/post/the-global-consensus-a-worldwide-rejection-of-4-mbc-by-95-nations)
Mizikovsky said reaching the formal consultation stage was an important moment after years of advocacy.
“This has been three years of work to protect Australian children from a chemical that is already banned, prohibited or not approved for sunscreen use in more than 60 countries."
“It has come at a significant personal and financial cost. As recently as last year, industry participants were attacking these concerns and arguing there was no issue that required action."
“We kept putting the scientific evidence, the international regulatory decisions and the Therapeutic Goods Administration’s own internal documents in front of decision-makers."
“For the Therapeutic Goods Administration to now complete its safety review and formally put regulatory restrictions, including a complete prohibition option, before the public is a significant step forward."
“For me, it shows that public safety is finally being given the priority it deserves over commercial interests and profits.”
Internal Therapeutic Goods Administration documents taken directly to Canberra
A central part of the Canberra meetings was the Australian Sunscreen Council’s collection of internal Therapeutic Goods Administration documents obtained through the Freedom of Information Act.
Mizikovsky took the documents to Canberra so that policymakers could see the regulator's internal scientific and scheduling discussions directly, rather than relying only on public statements.
Among the material discussed were ten documents obtained by the Australian Sunscreen Council under FOI reference 26-3100 concerning Homosalate, Oxybenzone and related scheduling decisions. (FOI 26-3100)
Those documents show that the Therapeutic Goods Administration had proposed restrictions on Homosalate, including listing it in the Poisons Standard and reducing its permitted concentration in therapeutic sunscreens. The regulator's scientific material recorded concerns relevant to systemic exposure, kidneys, fertility and development. (Australian Sunscreen Council, FOI 26-3100, July 2026). (FOI 26-3100)
The documents also record presentations to the joint scheduling committee by two industry lobby groups. The industry presentations raised commercial concerns about restrictions. (FOI 26-3100)
The Australian Sunscreen Council's position is that public safety must come first.
The Council considers the documents to show that necessary restrictions on Homosalate were delayed following lobbying from industry participants with financial and commercial interests in the affected ingredients.
The Council has also raised concerns about the length of time taken to progress regulatory action on 4-MBC despite overseas regulatory decisions and internal requests to prioritise its review.
The Australian Sunscreen Council asked Minister Butler's office to ensure that the Therapeutic Goods Administration follows its own scientific guidance and safety framework and that decisions intended to protect the Australian public are not delayed because of commercial lobbying or the financial interests of companies supplying or using imported chemical UV filters. (FOI 25-0017)
Meeting with Health Minister Mark Butler's office
Mark Butler has served in Federal Parliament since 2007 and is currently Minister for Health and Ageing and Minister for Disability and the National Disability Insurance Scheme.
He previously served as Minister for Ageing and as Australia's first federal Minister for Mental Health, as well as holding portfolios covering housing, climate change, water and the environment. Before entering Parliament, he spent more than 15 years working with the union movement. (The Hon Mark Butler MP | Health, Disability and Ageing Ministers | Australian Government Department of Health, Disability and Ageing)
The meeting with Minister Butler's office focused on the broader regulatory issue: Australians reasonably expect sunscreen ingredients permitted for repeated and long-term use to not have question marks over their safety, or worse yet be banned overseas due to safety concerns.
The Australian Sunscreen Council asked the Minister's office to ensure that where the Therapeutic Goods Administration's own assessments identify inadequate safety margins or recommend additional controls, those findings translate into timely regulatory decisions.
The discussions also addressed the importance of maintaining public confidence in sunscreen.
The Australian Sunscreen Council strongly supports effective sun protection and encourages Australians to use sunscreen alongside protective clothing, hats, sunglasses and shade. The Council's position is that public confidence is strengthened, not weakened, when legitimate ingredient safety concerns, such as those for Homosalate and 4-MBC, are investigated transparently and acted upon as a priority.
Dan Repacholi MP: health, outdoor workers and Australian manufacturing
Mizikovsky also met directly with Dan Repacholi MP, Federal Member for Hunter and Australia's first Special Envoy for Men's Health.
Repacholi was elected to Federal Parliament in 2022 and appointed Special Envoy for Men's Health in May 2025. Before entering Parliament he represented Australia at five Olympic Games, won Commonwealth Games gold, worked as a coal miner and worked in machinery sales servicing the mining and agricultural sectors. (Special Envoy Repacholi's biography | Health, Disability and Ageing Ministers | Australian Government Department of Health, Disability and Ageing)
His background made the discussion particularly relevant to the millions of Australian men working in construction, mining, agriculture, transport and other outdoor industries where sunscreen can form part of everyday workplace sun protection.
The meeting also expanded beyond regulation to discuss what improved sunscreen standards could mean for Australian manufacturing.
Mizikovsky said Repacholi was extremely receptive to the discussion and particularly supportive of the opportunities presented by Australian Made zinc sunscreen.
“Dan was extremely receptive to what we put in front of him, both from the public-health side and from the Australian manufacturing side."
“We spoke about the fact that Australia doesn't have to choose between improving sunscreen safety and protecting industry. We have the expertise and manufacturing capability here to make world-leading mineral sunscreens."
“Australian Made zinc sunscreen creates Australian manufacturing jobs, supports local supply chains and gives Australia an opportunity to show the rest of the world the expertise we have developed in pioneering high-performance mineral sunscreen.”
Australia already manufactures its own sunscreen grade zinc oxide
Importantly, Australia is not dependent on imported active sunscreen ingredients.
Advance ZincTek, through Antaria in Rocklea, Queensland, manufactures pharmaceutical and cosmetic-grade zinc oxide used in mineral sunscreens.
The Australian Made Campaign identifies Antaria as an Australian manufacturer of raw materials for mineral sunscreens, skin protection and cosmetic products, with its manufacturing operation based at Rocklea in Queensland. (Antaria - The Australian Made Campaign)
Advance ZincTek describes itself as Australia's largest supplier of cosmetic and pharmaceutical-grade zinc oxide powder used in sunscreens and personal-care products and reports approximately 5,000 tonnes of annual zinc oxide production capacity. Its products are distributed through more than 25 distributors across more than 40 countries. (Advance ZincTek, 2026). (advancezinctek.com)
Its ZinClear zinc oxide is manufactured under GMP conditions in Queensland and is marketed internationally as an Australian made mineral UV filter. (advancezinctek.com)
For the Australian Sunscreen Council, this demonstrates that stronger ingredient safety standards can also create an economic opportunity.
Australia has domestic raw-material manufacturing, sunscreen research expertise, Therapeutic Goods Administration-licensed production facilities and established manufacturers already exporting sunscreen products and ingredients into international markets.
Supporting Australian Made zinc oxide and Australian Made mineral sunscreen can help create local jobs, strengthen domestic supply chains, reduce reliance on imported chemical UV filters and showcase Australian sunscreen technology internationally.
A significant milestone for the Australian Sunscreen Council
The Australian Sunscreen Council welcomes the decision to formally consult on regulatory controls for 4-MBC.
The Therapeutic Goods Administration itself says its review was prompted by international regulatory decisions and that additional safeguards are now warranted. The regulator continues to recommend that Australians use sunscreen as part of broader sun protection measures. (Therapeutic Goods Administration, 11 September 2026). (TGA to consult on additional controls for an active sunscreen ingredient | Therapeutic Goods Administration (TGA))
The Australian Sunscreen Council also recognises that the consultation is not yet a final decision. The complete prohibition of 4-MBC is one of three options being considered, and the final regulatory outcome will follow the formal scheduling process.
Nevertheless, after years of Freedom of Information requests, scientific reviews, regulatory submissions, media engagement, public advocacy and direct discussions with government, having a complete prohibition option formally placed before Australia's scheduling process represents a significant milestone.
Mizikovsky thanked Minister Butler's office and Repacholi for engaging with the evidence.
“I sincerely thank Minister Butler's office and Dan Repacholi MP for taking the evidence seriously and giving us the opportunity to put the documents and the science directly in front of them."
“This issue has taken years of persistence. The important thing now is that the process remains transparent, that scientific evidence is given proper weight and that public safety comes first."
“Australia can lead the world in both sunscreen safety and sunscreen manufacturing. We already have Australian Made zinc oxide, world-class scientists and manufacturers capable of making high-performance mineral sunscreens here at home."
“Better sunscreen safety and stronger Australian manufacturing should go hand in hand.”
The Australian Sunscreen Council will continue participating in the 4-MBC consultation and advocating for evidence-based restrictions on sunscreen ingredients where the scientific evidence demonstrates that additional consumer protections are warranted.
References
Therapeutic Goods Administration, “TGA to consult on additional controls for an active sunscreen ingredient”, 11 September 2026. TGA media release
Therapeutic Goods Administration, “Public consultation on proposed amendments to the Poisons Standard in relation to 4-MBC”, Joint ACMS-ACCS #45, November 2026. 4-MBC public consultation
Therapeutic Goods Administration, “Safety review of 4-Methylbenzylidene Camphor (4-MBC)”, September 2026. TGA 4-MBC safety review
Australian Sunscreen Council, “FOI Release: TGA Documents on the Scheduling of Homosalate, Oxybenzone and Octocrylene”, FOI 26-3100, July 2026. Australian Sunscreen Council FOI release
Australian Sunscreen Council, “The Global Consensus: A Worldwide Rejection of 4-MBC by 95 Nations”, August 2026. Australian Sunscreen Council international 4-MBC review
Australian Government Department of Health, Disability and Ageing, “Minister Butler's biography”. Mark Butler biography
Australian Government Department of Health, Disability and Ageing, “Special Envoy Repacholi's biography”. Dan Repacholi biography
Australian Made Campaign, “Antaria”. Australian Made – Antaria
Advance ZincTek, Australian zinc oxide manufacturing and production information. Advance ZincTek
