UV Filter Safety in Australia: Why Sponsors Need Their Own Evidence on 4-MBC and Homosalate
Sponsors must already hold evidence that their sunscreen is safe. With Europe having banned 4-MBC and restricted homosalate, and the TGA now reviewing both, Dr Leslie Laquieze explains why product-specific safety data has become essential.
By Dr Leslie Laquieze, PharmD, MSc, PhD, MBA, Expert Member, Australian Sunscreen Council
Safety starts with the sponsor’s own dossier
Under Australian law, the sponsor of a listed sunscreen must certify that the product meets all applicable requirements for safety, quality and efficacy. The TGA states on its Sunscreen ingredients page that “listed therapeutic sunscreens are included in the ARTG without a pre-market evaluation,” and on its page Sunscreen regulation in Australia that “the sponsor must legally certify when they list their product that it meets all applicable legislative requirements in relation to safety, quality and efficacy.” Sponsors should therefore already hold their own safety dossier showing that each sunscreen is safe for its intended use.
What Europe has already decided
For 4-MBC and homosalate, the European Union has already acted, with sunscreens there regulated as cosmetics. The EU Scientific Committee on Consumer Safety (SCCS), in its final opinion on 4-MBC of 29 April 2022, stated: “The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity. Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems.” It added that “it is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded.”
In Commission Regulation (EU) 2024/996, the European Commission concluded that “in light of the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of 4-Methylbenzylidene Camphor as a UV-filter in cosmetic products,” and that the substance “should be prohibited for all use in cosmetic products.” From 1 May 2025, products containing 4-MBC could not be placed on the EU market, and from 1 May 2026 they could not be made available on it.
For homosalate, Commission Regulation (EU) 2022/2195 records that the SCCS “concluded in its opinion of 24-25 June 2021 that Homosalate is not safe when used as a UV-filter in cosmetic products at concentrations of up to 10 %,” and found it “safe for the consumer only up to a maximum concentration of 0,5 % in the final product.” Following further industry data, the EU restricted homosalate to face products (non-spray and pump spray) at no more than 7.34 per cent, with non-compliant products barred from being placed on the market from 1 January 2025 and from being made available from 1 July 2025.
These European conclusions materially raise the evidence and governance burden for products containing 4-MBC or homosalate, but they should not be presented as if they were already Australian final decisions. Australian sponsors should document a product- and use-specific safety rationale, review the TGA exposure assumptions and proposed controls, and plan proportionate alternatives where relevant. This does not mean that each sponsor should commission a new standalone toxicology programme; the appropriate evidence package should be determined by the ingredient, exposure, existing authoritative assessments and applicable Australian requirements.
How the TGA now assesses exposure
A sunscreen must not only protect; its ingredients must also be safe at the exposure Australians actually experience. In a country where many people apply sunscreen daily, over large areas of skin and for years, that exposure can be substantial. The Therapeutic Goods Administration now assesses it with a dedicated tool.
The TGA published the Australian Sunscreen Exposure Model (ASEM) on 1 August 2025. The TGA states that the ASEM “performs sunscreen exposure calculations that reflect the unique conditions and practices in Australia,” recognising that use varies with habits, climate, time outdoors, cost, organisational policies for childcare, school or work, and perceived skin-cancer risk. The TGA’s guidance Understanding the regulation of therapeutic sunscreens notes that “the ASEM will now be used for assessing new ingredients that can absorb through the skin.”
Sponsors should incorporate the ASEM early whenever a formula relies on an ingredient that may be absorbed through the skin.
4-MBC: a safety review and three options
On 11 September 2026, the TGA published its Safety review of 4-Methylbenzylidene Camphor (4-MBC). The TGA explains that “a MoS [margin of safety] of 100 or more is considered to be satisfactory,” and that “the MoS using the highest estimated sunscreen exposure for application of a general sunscreen to the body, at the maximum permitted concentration, was less than 100.” It concluded that “the TGA recommends regulatory controls for 4-MBC to restrict its permitted concentration and use in therapeutic sunscreens.”
A public consultation on amending the Poisons Standard for 4-MBC opened on 11 September 2026 and closed on 12 October 2026, ahead of a joint meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling in November 2026. It presents three options:
Option | Proposed by | Summary | Portfolio action |
Option 1 | The delegate | Schedule 5, except in preparations containing 0.39% or less of 4-MBC, for therapeutic sunscreens and cosmetics. | Identify formulas above 0.39%; model reformulation and transition. |
Option 2 | The delegate | Schedule 5, with exemptions for face-and-hands therapeutic sunscreens at 0.95% or less; for face-and-hands therapeutic sunscreens at 3.8% or less for persons aged 18 and over; and for face-and-hands cosmetics at 3.3% or less. | Map concentration, application site, age, regulatory status and directions for use. |
Option 3 | Both applicants | Schedule 10: prohibit 4-MBC “when used in therapeutic goods or cosmetic products.” | Assess full replacement, SPF and UVA performance, stability and supply chain. |
The consultation closed on 12 October 2026. None of these options is yet a final limit, ban, recall or instruction to stop use. The TGA’s Sunscreen ingredients page indicates that an interim decision on 4-MBC is expected in 2027, after which it will be subject to further public consultation.
Homosalate, oxybenzone and benzophenone
In July 2025, the TGA published a safety review of seven active sunscreen ingredients and a separate review of benzophenone. According to the TGA’s Sunscreen ingredients page, no rule changes are required for five ingredients, but changes are proposed for three. The TGA states that “homosalate and oxybenzone are active ingredients that can potentially be absorbed through the skin and may cause harmful effects if used in high concentrations, over large areas and over an extended amount of time,” and that benzophenone “is not a permitted ingredient, but a substance that may potentially be formed in the manufacturing process or from incorrect storage conditions.” The interim decision on these ingredients is to be published and subject to public consultation by the end of 2026.
Each of these stages should be tracked separately: safety review, consultation, interim decision, final decision, effective date and transition. Treating a proposal as a decision, or a consultation option as a final limit, leads to costly errors in either direction.
Formulation research is not a safety conclusion
Formulation affects how deeply some chemical UV filters travel into the skin. A 2026 study by Zhang and colleagues in Photodermatology, Photoimmunology & Photomedicine, using in-vivo confocal Raman spectroscopy, reported that among the filters tested “HMS [homosalate] exhibited the highest permeation, with a relative permeability rate of 4.2% and a maximum permeation depth of 60 μm,” and that certain thickeners and emulsifiers reduced homosalate permeation. The authors are employees of cosmetics companies. The study is useful for comparing prototypes, but it is neither a validated measure of systemic exposure nor a safety conclusion, and it is not a basis for pre-empting the TGA’s decision.
What sponsors should do now
· Maintain a matrix of filter, market, concentration, restriction, effective date and transition.
· Qualify the grade, purity, impurities and certificates of analysis for every UV filter, and reassess after supplier or process changes.
· Control storage and manufacturing conditions that could generate degradants such as benzophenone.
· Assess the complete formulation and intended use, not only the nominal concentration of one filter.
· Begin replacement and reformulation work early for formulas affected by any option under consideration, so that SPF and UVA performance can be revalidated without supply interruptions.
The TGA’s Sunscreen ingredients page continues to advise Australians to keep using sunscreen while ingredient reviews are under way.
Sources
· European Commission, SCCS, “Opinion on 4-Methylbenzylidene camphor (4-MBC)”, final version 29 April 2022: https://health.ec.europa.eu/system/files/2023-08/sccs_o_262.pdf
· Commission Regulation (EU) 2024/996 of 3 April 2024: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0996
· Commission Regulation (EU) 2022/2195 of 10 November 2022: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2195
· Therapeutic Goods Administration, “Sunscreen regulation in Australia”: https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/overview/sunscreen-regulation-australia
· Therapeutic Goods Administration, “Australian Sunscreen Exposure Model”, 1 August 2025: https://www.tga.gov.au/resources/publication/corporate-reports/australian-sunscreen-exposure-model
· Therapeutic Goods Administration, “Understanding the regulation of therapeutic sunscreens”: https://www.tga.gov.au/resources/guidance/understanding-regulation-therapeutic-sunscreens
· Therapeutic Goods Administration, “Safety review of 4-Methylbenzylidene Camphor (4-MBC)”, 11 September 2026: https://www.tga.gov.au/resources/publication/corporate-reports/safety-review-4-methylbenzylidene-camphor-4-mbc
· Therapeutic Goods Administration, 4-MBC Poisons Standard consultation, Joint ACMS-ACCS #45, November 2026: https://consultations.tga.gov.au/tga/scheduling-pre-meeting-notice-4mbc-nov-2026/
· Therapeutic Goods Administration, “Sunscreen ingredients”: https://www.tga.gov.au/resources/explore-topic/sunscreens/sunscreen-ingredients
· Zhang T et al., Photodermatol Photoimmunol Photomed, 2026;42:e70116: https://onlinelibrary.wiley.com/doi/10.1111/phpp.70116
About the Author
Dr Leslie Laquieze (PharmD, MSc, PhD, MBA) is a pharmacist-scientist and international expert in sunscreen testing, photoprotection, skin pharmacology and dermocosmetic claim substantiation. An expert member of the Australian Sunscreen Council, she has led Kosmoscience Europe since 2018, supporting the evaluation, substantiation and regulatory positioning of cosmetic and dermatological products across international markets.
This article reflects the opinion of Dr Leslie Laquieze. Readers are recommended to seek expert legal advice on all issues discussed.
