On September 11, 2026, the Therapeutic Goods Administration (TGA) of Australia opened a public consultation on amendments to the Poisons Standard to strengthen the control of 4-methylbenzylidene camphor (4-MBC), a sunscreen ingredient. Submissions are due by October 12, 2026. Three options have been proposed: uniformly lowering the permitted concentration, applying tiered limits on its use, or outright prohibiting its use in therapeutic sunscreens and cosmetics. CIRS Group has summarized the key points as follows for your reference.
Current Regulatory Status of 4-MBC in Australia
4-Methylbenzylidene camphor (4-MBC) is a UVB sunscreen filter that absorbs ultraviolet radiation in the 280–320 nm range. It is a crystalline solid at room temperature and is practically insoluble in water. In Australia, 4-MBC is not currently scheduled in the Poisons Standard, and its maximum permitted concentration in therapeutic sunscreen products and cosmetics is 4%. Under current requirements, sunscreen products containing 4-MBC must also carry label warnings such as “Avoid prolonged exposure to the sun” and “When exposed to the sun, wear protective clothing, a hat and protective eyewear” (or similar wording).
Key Safety Findings
The safety assessment of 4-MBC focused on two key questions:
- Whether 4-MBC can penetrate the skin into the human body and produce systemic absorption;
- Whether the ingredient poses potential toxicological hazards.
The assessment employed TGA’s latest Australian Sunscreen Exposure Model (ASEM) and applied Australia’s current safety evaluation benchmark: a margin of safety (MoS) of ≥100 is considered acceptable in terms of the human health risk from long-term use of the ingredient by the Australian population. The assessment was calculated on the basis of the maximum permitted concentration in therapeutic sunscreen products.
The assessment data show that, under the scenario of routine whole-body application at the maximum permitted concentration, the MoS for 4-MBC falls below 100, failing to meet the safety benchmark and indicating risk from long-term use. The calculations were therefore repeated for restricted-application scenarios. The results indicate that if application is limited to specific body sites such as the head, face and/or hands, and the concentration is controlled within the range of 3.8%–16.5% depending on the product type and directions for use, the MoS for 4-MBC can reach 100 or above. Under these restricted conditions, the long-term use risk of the ingredient is relatively low.
Proposed Control Options
To strengthen control, the TGA (Delegate) has proposed adding 4-MBC to the Poisons Standard as a new entry, restricting its permitted concentration and use in therapeutic sunscreen products and cosmetics through scheduling; meanwhile, two applications received by the TGA propose an outright prohibition of 4-MBC.
The consultation sets out the following three options:
Option 1: A new Schedule 5 entry, under which therapeutic sunscreen products and cosmetics would be included in Schedule 5, except preparations containing no more than 0.39% of 4-MBC;
Option 2: A new Schedule 5 entry, with exemptions tiered by product type, application site and population:
- Therapeutic sunscreen products for the face and hands: no more than 0.95% of 4-MBC;
- Therapeutic sunscreen products for the face and hands, intended for persons aged 18 and over: no more than 3.8% of 4-MBC;
- Cosmetic products for the face and hands: no more than 3.3%;
Option 3 (proposed by the applicants): A new Schedule 10 entry, prohibiting the use of 4-MBC in therapeutic goods and cosmetics altogether.
Note: According to the consultation document, this is a pre-meeting public consultation. After the submission deadline, the materials received will be submitted for consideration at the joint ACMS-ACCS meeting scheduled for November 2026. Following the committees’ advice, the TGA will make an interim decision and further public consultation will be conducted, after which the final decision will be formed. The final scheduling entry, concentration limits and transitional arrangements for 4-MBC under the Poisons Standard will all be subject to the final decision.
Global Regulatory Landscape of 4-MBC
European Union: Owing to concerns over its potential endocrine-disrupting properties, 4-MBC was removed from the list of permitted UV filters in Annex VI of the EU Cosmetics Regulation under Regulation (EU) 2024/996.
From May 1, 2025, products containing 4-MBC must not be placed on the EU market; from May 1, 2026, they must not be made available on the EU market;
United Kingdom: In May 2025, the UK Scientific Advisory Group on the Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) published its assessment opinion, in which members unanimously agreed that 4-MBC exhibits clear endocrine-disrupting properties and that, based on the available evidence, a safe level of use of the ingredient in cosmetics could not be determined, ultimately concluding that the safety of 4-MBC in sunscreen products and other cosmetics could not be confirmed.
From July 15, 2026, new cosmetic products containing 4-MBC must not be placed on the market; from January 15, 2027, products containing 4-MBC must not be sold;
United States: 4-MBC is not included in the U.S. OTC sunscreen monograph;
Canada: Permitted, with a maximum permitted concentration of 4%;
China: Under NMPA Announcement No. 6 of 2026, 4-methylbenzylidene camphor has been reclassified from a permitted UV filter to a prohibited ingredient, effective January 1, 2027; cosmetic products already manufactured or imported before that date may continue to be sold until the end of their shelf life.
Implications and Recommendations for Cosmetic Enterprises
1. Enterprises exporting to Australia: Australia’s concentration rules for 4-MBC in sunscreen products are still being refined, and the final control limits and transitional arrangements have not yet been formalized. Relevant enterprises are advised to carry out formulation risk assessments in advance, actively prepare alternative options, closely follow the outcomes of the local consultation and the progress of standard amendments, and plan their compliance measures ahead of time;
2. Enterprises exporting to the EU and the UK: The EU has prohibited the sale of products containing 4-MBC within its territory since May 1, 2026, and the UK will do so from January 15, 2027. Relevant enterprises should check their formulations and raw material supply chains and, where necessary, adjust the specifications of exported products to avoid customs clearance failures or forced delisting;
3. Screen the entire product range for 4-MBC: 4-MBC is used not only in therapeutic sunscreen products but may also be present in cosmetic sunscreen products, posing multi-channel exposure risks. Enterprises are advised to conduct a full-line product review covering all product categories with sun-protection functions, and to optimize their global formulation systems and marketing claim strategies in a coordinated manner, taking into account regulatory differences across export markets, so as to achieve compliance across all regions.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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