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Türkiye Moves to Ban 4-MBC, Listed by the UN as a Category 1 Hormone Disruptor, From Sunscreen. Australia Still Uses It

16 minutes ago
8 min read

Banned in 95 nations and linked to hormone disruption, 4-MBC is still used in Australian sunscreen. Türkiye is about to ban it too.


Photo illustration: the flag of Türkiye and a UN report table, 4-MBC row magnified. Hero image: Türkiye moves to ban 4-MBC, a sunscreen chemical the EU rated Category 1 as an endocrine disruptor, as recorded by the UN. Australia still uses 4-MBC.

Türkiye is moving to ban 4-MBC, a UV filter used in sunscreen. Its medicines agency, TİTCK, has drafted the rule. The draft adds 4-MBC to Türkiye's list of banned cosmetic ingredients (Türkiye İlaç ve Tıbbî Cihaz Kurumu [TİTCK], n.d.-a, p. 3). It also deletes 4-MBC's row from the list of permitted UV filters (TİTCK, n.d.-a, p. 1, art. 5). Industry comments closed on 7 September 2026 (İstanbul Kimyevi Maddeler ve Mamulleri İhracatçıları Birliği [IKMİB], n.d.). As at 10 October 2026, the rule had not appeared in Türkiye's Official Gazette (T.C. Resmî Gazete, 2026).


Why now? Türkiye is lining up with Europe. Istanbul's chemical exporters' association, IKMİB, shared the draft with industry. It said the draft aims to bring Türkiye's cosmetic rules into line with "the updated European Union Cosmetics Regulation" (IKMİB, n.d., the Council's translation). TİTCK's own comparison table gives the same reason for the UV filter change. The update is "consistent with EU Cosmetics Regulation 1223/2009" (TİTCK, n.d.-b, the Council's translation).


And Europe has banned 4-MBC. Europe's scientists found it "may act as an endocrine disruptor", meaning it may interfere with hormones (European Commission, 2024, recital 12). It has "effects on both the thyroid and estrogen systems" (European Commission, 2024, recital 12).


Then the key finding. "It is not possible to derive a maximum concentration for safe use," the European Commission recorded (European Commission, 2024, recital 12).


Türkiye's rule would bite fast. "This Regulation enters into force on the date of its publication," Article 10 of the draft says (TİTCK, n.d.-a, p. 2, the Council's translation).


Europe and Britain led the way


4-MBC was never approved in the US or Japan. It isn't on either country's list of permitted sunscreen ingredients (Sunscreen Active Ingredients, 2026; Ministry of Health, Labour and Welfare [MHLW], 2000, Appendix 4). Now Europe has banned it. Europe's ban is already in force. Since 1 May 2026, cosmetics containing 4-MBC can't be sold anywhere in the European Union (European Commission, 2024).


Europe's safety committee had assessed 4-MBC at 4%, the highest level allowed in cosmetics. The verdict: 4-MBC at that level "would not be safe" (Scientific Committee on Consumer Safety [SCCS], 2022, p. 3). The committee's opinion records another warning. Europe's chemicals agency had unanimously named 4-MBC a substance of very high concern. It cited "probable serious effects to human health" (SCCS, 2022, p. 28).


Britain followed. Its scientific advisers said 4-MBC "should be regarded as a reproductive and developmental toxicant", a chemical that may harm fertility and how babies develop (Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products [SAG-CS], 2025, p. 5). The advisers were "not able to derive a safe level" (SAG-CS, 2025, p. 6).


Britain's product safety office had asked industry for safety data first. The answer? "No additional data were received" (SAG-CS, 2025, p. 2).


Britain banned 4-MBC from 15 July 2026. It cited "a potential risk to human health" (The Cosmetic Products Regulation, 2026, p. 1). China and Southeast Asia's ASEAN countries have adopted bans that start from 2027 (National Medical Products Administration [NMPA], 2026; ASEAN Cosmetic Committee, 2026).


Türkiye would hardly be alone. By the Council's count, 4-MBC is "actively prohibited across 95 nations" (Australian Sunscreen Council, 2026). Some ban it outright. Some must follow EU rules. Others leave it off their lists of approved ingredients. The count does not yet include Türkiye (Australian Sunscreen Council, 2026).


Australia still uses it


Australia is not on that list. Sunscreens here can contain up to 4% 4-MBC (TGA, 2026b, p. 11). On 25 August 2026, 107 medicines on Australia's register contained it (Therapeutic Goods Administration [TGA], 2026a, p. 9).


That's despite the regulator's own words. In June 2025, members of the Australian Sunscreen Council asked Australia's medicines regulator to take 4-MBC out of listed medicines (TGA, 2026c). The regulator is the Therapeutic Goods Administration (TGA). Its delegate ruled in January 2026. The delegate agreed no margin of safety could be reached. And "a safe dose of the ingredient cannot be established" (TGA, 2026c).


Then the delegate said no anyway, pointing to another path. The scheduling process, the delegate wrote, "is better suited to considering the issues raised by your application" (TGA, 2026c). 4-MBC stayed on the permitted list.


None of this is new to the TGA. Its own files go back two decades. In November 2005, a TGA senior toxicologist wrote a file note. It said "a no-effect level cannot be determined" (TGA, 2005, p. 424). The advice was to "wait for the outcome" of Europe's review (TGA, 2005, p. 425).


The TGA waited. In 2022, an internal TGA briefing passed on Europe's draft view. It said 4% "does not appear to be safe" (TGA, 2022, p. 215). The same briefing counted "206 listed sunscreen products" using the chemical (TGA, 2022, p. 215).


It reaches people


Why does the delay matter? Because the chemical gets into people. Swiss mothers gave breast milk samples between 2004 and 2006. The samples "contained detectable levels of 4-MBC", the TGA's own review notes (TGA, 2026b, p. 26).


Animal studies point to the next generation. Offspring of treated rats showed "dose-dependent delays in male puberty onset" (TGA, 2026b, p. 25).


The TGA's review found no cancer studies at all. "There are no carcinogenicity studies available for 4-MBC" (TGA, 2026b, p. 7).


That same review was finished in July 2026. At 4%, it says, 4-MBC "is not deemed to present a low risk" (TGA, 2026b, p. 11). Its margin of safety came out at 9.7 (TGA, 2026b, p. 9). The TGA says a margin of 100 or more "is generally considered safe" (TGA, 2026b, p. 8). That puts 4-MBC at less than a tenth of the safe mark.


A label, not a ban


Then came the scheduling path the delegate had pointed to. In September 2026, the TGA opened consultation. Its first option would not ban 4-MBC. It would add a warning label (TGA, 2026a, p. 7). Products with about a tenth of today's maximum wouldn't even need that (TGA, 2026a, p. 7).


A call for a ban came through that path too. Two private applicants asked the TGA to prohibit 4-MBC outright (TGA, 2026a, pp. 6, 8). Members of the Australian Sunscreen Council were among them. They argued "no warning label can appropriately address the fundamental inability to establish a safe dose" (TGA, 2026a, p. 8).


Submissions closed on 12 October 2026 (TGA, 2026a, p. 4). The TGA must now choose. A label, or a ban like Europe's, Britain's and now Türkiye's.


The Australian Sunscreen Council is calling on the TGA to ban 4-MBC in sunscreen. One reason is the TGA delegate's own finding that "a safe dose of the ingredient cannot be established" (TGA, 2026c).


Non-nano zinc oxide is the only broad-spectrum UV filter that is reef safe and Generally Recognized As Safe and Effective (GRASE) by the US FDA (National Oceanic and Atmospheric Administration [NOAA], n.d.; National Park Service [NPS], n.d.; U.S. Food and Drug Administration [FDA], 2019, p. 6206; Beasley & Meyer, 2010; Hanrahan, 2012). On its own it protects across the full UVA and UVB range, including long UVA (Beasley & Meyer, 2010; Hanrahan, 2012).



About the Australian Sunscreen Council


The Australian Sunscreen Council is a registered Australian charity dedicated to improving the health of everyday Australians through UV education, research and evidence-based sun safety initiatives.


As Australia’s peak industry body for sunscreen safety, the Council works with scientists, medical professionals, industry experts and policymakers to advance sunscreen safety, support independent research, improve public understanding of UV exposure and promote stronger public-health standards.


ABN 64 692 134 982



Australian Sunscreen Council Editorial Team


The Council is supported by an Expert Group and may draw on advice from one or more members depending on the subject matter of a particular article, submission or publication. Members listed by the Council include (Australian Sunscreen Council, n.d.):


  • Dr Craig Downs, Executive Director, Haereticus Environmental Laboratory

  • Dr Russell Hills, cosmetic and laser dermatologist and Mohs specialist

  • Dr Denis Dudley, obstetrician-gynaecologist and endocrinologist

  • Dr Abhinandan “Rocky” Chowdhury, toxicologist

  • Dr Leslie Laquieze, sunscreen testing and photoprotection

  • Mgr. Mehrdad Mirzaei, pharmacist and photoprotection researcher

  • Joseph DiNardo, cosmetic toxicologist

  • Dr Alan Jones, skin cancer physician

  • Camila Biato Stopa, MSc, cosmetic scientist and pharmacist




Acknowledgment


Grok was used in the creation of this article. Always read the sunscreen label and use only as directed. Sunscreen is only one part of sun protection. Avoid prolonged sun exposure and wear protective clothing, hats, and eyewear.



References


ASEAN Cosmetic Committee. (2026, June 10). ASEAN Cosmetic Directive, Annex II: List of substances which must not form part of the composition of cosmetic products (Ref. No. 1723, 4-methylbenzylidene camphor) [Release published by the National Pharmaceutical Regulatory Agency, Malaysia]. https://npra.gov.my/images/Guidelines_Central/Guidelines_on_Cosmetic/Annex_II_release_-_10_June_2026.pdf


Australian Sunscreen Council. (n.d.). Scientific experts in sunscreen safety. Retrieved October 10, 2026, from https://www.australiansunscreencouncil.org/scientific-experts-sunscreen-safety


Australian Sunscreen Council. (2026, August 26; updated 2026, September 30). The global consensus: A worldwide rejection of 4-MBC by 95 nations. https://www.australiansunscreencouncil.org/post/the-global-consensus-a-worldwide-rejection-of-4-mbc-by-95-nations


Beasley, D. G., & Meyer, T. A. (2010). Characterization of the UVA protection provided by avobenzone, zinc oxide, and titanium dioxide in broad-spectrum sunscreen products. American Journal of Clinical Dermatology, 11(6), 413–421. https://doi.org/10.2165/11537050-000000000-00000


European Commission. (2024, April 3). Commission Regulation (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products. Official Journal of the European Union, L series. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202400996


Hanrahan, J. R. (2012). Sunscreens. Australian Prescriber, 35(5), 148–151. https://doi.org/10.18773/austprescr.2012.068


İstanbul Kimyevi Maddeler ve Mamulleri İhracatçıları Birliği. (n.d.). Kozmetik Ürünler Yönetmeliği değişiklik taslağı hakkında görüş talebi. Retrieved October 10, 2026, from https://ikmib.org.tr/duyuru/kozmetik-urunler-yonetmeligi-degisiklik-taslagi-hakkinda-gorus-talebi


Ministry of Health, Labour and Welfare. (2000). Standards for cosmetics [化粧品基準] (Ministry of Health and Welfare Notification No. 331 of 2000, Appendix 4; consolidated edition dated July 12, 2024). https://www.mhlw.go.jp/content/000491511.pdf


National Medical Products Administration. (2026, January 12). Announcement No. 6 of 2026 [国家药监局公告2026年第6号]. https://www.nmpa.gov.cn/hzhp/hzhpjmtg/20260112145634170.html


National Oceanic and Atmospheric Administration. (n.d.). Skincare chemicals and marine life. National Ocean Service. Retrieved October 10, 2026, from https://oceanservice.noaa.gov/news/sunscreen-corals.html


National Park Service. (n.d.). Sunscreen. U.S. Department of the Interior. Retrieved October 10, 2026, from https://www.nps.gov/subjects/oceans/sunscreen.htm


Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products. (2025). Opinion on 4-methylbenzylidene camphor as a UV filter in cosmetic products (SAG-CS Opinion 18). Office for Product Safety and Standards. https://assets.publishing.service.gov.uk/media/682ddebab33f68eaba95390b/sag-cs-opinion-18-4-mbc-as-a-uv-filter-in-cosmetic-products.pdf


Scientific Committee on Consumer Safety. (2022). Opinion on 4-methylbenzylidene camphor (4-MBC) (SCCS/1640/21, final version, adopted 29 April 2022). European Commission. https://health.ec.europa.eu/system/files/2023-08/sccs_o_262.pdf



T.C. Resmî Gazete. (2026). Günlük fihrist [Daily indexes, 1 September–10 October 2026]. Retrieved October 10, 2026, from https://www.resmigazete.gov.tr/eskiler/2026/10/20261010.htm


The Cosmetic Products Regulation (EC) No 1223/2009 (Restriction of Chemical Substances) (Amendment and Transitional Provisions) Regulations 2026, SI 2026/23. (2026). https://www.legislation.gov.uk/uksi/2026/23/made


Therapeutic Goods Administration. (2005, November 11). File note: 4-methylbenzylidene camphor [Senior Toxicologist, OTC Medicines Evaluation Section; released under FOI 25-0009]. https://www.tga.gov.au/sites/default/files/2025-01/FOI%2025-0009%20Documents.pdf


Therapeutic Goods Administration. (2022). Internal briefing: Other current sunscreens issues from across the TGA [Undated; released under FOI 25-0010, Document 8]. https://www.tga.gov.au/sites/default/files/2024-12/FOI%2025-0010%20Documents.pdf


Therapeutic Goods Administration. (2026a, September 11). Consultation: Proposed amendments to the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC) – Joint ACMS-ACCS #45 meeting, November 2026 [Public notice]. https://consultations.tga.gov.au/tga/scheduling-pre-meeting-notice-4mbc-nov-2026/user_uploads/pre-meeting-public-notice---4-mbc---november-2026-3.pdf


Therapeutic Goods Administration. (2026b). Safety review of 4-Methylbenzylidene Camphor (4-MBC) (Version 1.0, July 2026). https://www.tga.gov.au/sites/default/files/2026-09/safety-review-4-methylbenzylidene-camphor-4-mbc.pdf


Therapeutic Goods Administration. (2026c, January 16). Notice of decision to refuse to make a recommendation to vary the section 26BB determination (4-methylbenzylidene camphor) (IN-2025-AP-000920) [Not publicly released; text verified against the Council's research-library copy].


Türkiye İlaç ve Tıbbî Cihaz Kurumu. (n.d.-a). Kozmetik Ürünler Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik [Draft regulation amending the Cosmetic Products Regulation]. Distributed by IKMİB. Retrieved October 10, 2026, from https://ikmib.org.tr/duyuru/kozmetik-urunler-yonetmeligi-degisiklik-taslagi-hakkinda-gorus-talebi


Türkiye İlaç ve Tıbbî Cihaz Kurumu. (n.d.-b). Karşılaştırma tablosu [Comparison table for the draft regulation amending the Cosmetic Products Regulation]. Distributed by IKMİB. Retrieved October 10, 2026, from https://ikmib.org.tr/duyuru/kozmetik-urunler-yonetmeligi-degisiklik-taslagi-hakkinda-gorus-talebi


U.S. Food and Drug Administration. (2019, February 26). Sunscreen drug products for over-the-counter human use (Proposed rule, 84 Fed. Reg. 6204; Docket No. FDA-1978-N-0018). Federal Register. https://www.govinfo.gov/content/pkg/FR-2019-02-26/pdf/2019-03019.pdf


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