With 4-MBC legally prohibited across Europe, systematically erased from major export markets in Asia, Latin America, and Africa, and unapproved by the US FDA and Japan's MHLW, the international consensus is clear. In total, 4-MBC is now actively prohibited across 78 nations and 31 overseas territories, representing 109 distinct geographic jurisdictions worldwide.

Nine News investigative report into a TGA FOI (Freedom of Information) document revealing that the TGA is aware of endocrine disrupting risks of 4-MBC. Watch the full Nine News Broadcast on "Are there dangerous chemicals in your child's sunscreen?"

Comprehensive List of 109 Jurisdictions Restricting or Prohibiting 4-MBC

(May 2026)

Note: For the purposes of this regulatory review, a "Prohibition/Restriction" is defined as an active legislative prohibition, an administrative rejection via mandatory international safety alignment, practical exclusion through recognized regulatory frameworks, or strict omission from a mandatory positive list

1. The European Single Market (EU & EEA Mainland – 30 Nations)

• Countries Explicitly Bound: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.

• Legal Framework: Commission Regulation (EU) 2024/996 amending Regulation (EC) No 1223/2009. The EEA Joint Committee Decision automatically incorporates this regulation, making it legally binding in the EEA nations (Iceland, Liechtenstein, Norway).

• Official Quote: "The substance ‘3-(4′-methylbenzylidene)-camphor’ (CAS No 36861-47-9/38102-62-4)... is deleted [from Annex VI]... [and] is added to Annex II [List of prohibited substances]."

• Implementation Deadline: Complete sales prohibition effective May 1, 2026.

• Official URL: https://eur-lex.europa.eu/eli/reg/2024/996/oj

2. ASEAN / Southeast Asian Nations (10 Nations)

• Countries Explicitly Bound: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam.

• Legal Framework: ASEAN Cosmetic Directive (ACD), updated via the ASEAN Cosmetic Committee (ACC) Jakarta resolution.

• Official Quote: "The latest ASEAN Cosmetic Directive update amends Annexes II and III... 4-methylbenzylidene camphor [is] now prohibited (Annex II)."

• Official URL: https://asean.org/our-communities/economic-community/standards-and-conformance/

3. EAC / East African Community (8 Nations)

• Countries Explicitly Bound: Burundi, Democratic Republic of the Congo, Kenya, Rwanda, Somalia, South Sudan, Tanzania, Uganda.

• Legal Framework: East African Standard DEAS 377-1:2020 (Cosmetics and cosmetic products — Part 1: List of substances prohibited).

• Official Quote: "Cosmetic products shall not contain any of the prohibited substances listed in Annex II of Regulation (EC) No. 1223/2009 on cosmetic products... (as amended from time to time)."

• Official URL: https://catalog.easc.org/

4. SICA / Central American Integration System (6 Nations)

• Countries Explicitly Bound: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama.

• Legal Framework: Reglamento Técnico Centroamericano (RTCA) 71.03.35:21 (Productos Cosméticos: Registro e Inscripción Sanitaria).

• Official Quote: "El Reglamento (CE) No 1223/2009 del Parlamento Europeo y del Consejo y sus actualizaciones: a) Anexo II (Lista de sustancias prohibidas en productos cosméticos)..." The phrase "and its updates" automatically legally binds these 6 nations to the EU prohibition.

• Official URL: https://www.sieca.int/

5. The United Kingdom (4 Nations)

• Countries Explicitly Bound: England, Scotland, Wales, Northern Ireland.

• Legal Framework: The Cosmetic Products (Restriction of Chemical Substances) Regulations 2026 (GB). Northern Ireland aligns dynamically with EU Regulation 2024/996 under the Windsor Framework.

• Official Quote: "Based on a recent SAG-CS opinion concluding that no safe use level could be established for the UV filter 4-Methylbenzylidene Camphor (4-MBC), the ingredient has been added to Annex II, effectively banning its use in cosmetics in Great Britain."

• Official URL: https://www.gov.uk/guidance/submit-a-cosmetic-product-notification

6. United States of America

• Legal Framework: U.S. Food and Drug Administration (FDA) – OTC Sunscreen Monograph.

• Official Mechanism: The FDA regulates sunscreens as OTC drugs and maintains a strict positive list of Generally Recognized as Safe and Effective (GRASE) ingredients. 4-MBC (Enzacamene) is not included in the FDA's GRASE list, classifying it as an unapproved drug legally prohibited from being marketed.

• Official URL: https://www.fda.gov/

7. Japan

• Legal Framework: Ministry of Health, Labour and Welfare (MHLW) – Standards for Cosmetics.

• Official Mechanism: Japan utilizes a strict positive list system for UV filters. Because 4-MBC has never been approved and is completely omitted from the positive list, it is legally prohibited from being sold as a sunscreen.

• Official URL: https://www.mhlw.go.jp/

8. The People's Republic of China

• Legal Framework: National Medical Products Administration (NMPA) Announcement No. 6 of 2026.

• Official Quote: "The announcement adds 7 raw materials to the 'Cosmetics Prohibited Raw Materials Directory', which are: ... (1) 4-Methylbenzylidene Camphor: formerly a permitted UV filter."

• Official URL: https://www.nmpa.gov.cn/xxgk/ggtg/hzhpggtg/hzhpcpggtg/

9. Switzerland

• Legal Framework: Swiss Foodstuffs and Utility Articles Ordinance (LGV), enforced by the Federal Food Safety and Veterinary Office (BLV).

• Official Mechanism: "Under Article 54 of the Swiss Foodstuffs and Utility Articles Ordinance (LGV), Swiss law directly references and adopts the dynamic, updated annexes of the EU Cosmetics Regulation (EC) No 1223/2009."

• Official URL: https://www.fedlex.admin.ch/eli/cc/2017/164/en

10. Principality of Monaco

• Legal Framework: Franco-Monegasque Customs Convention / EU Cosmetics Regulation (EC) No 1223/2009.

• Official Mechanism: Monaco shares a strict customs and regulatory union with France. European consumer safety laws apply directly to the Monegasque market. Consequently, the Annex II prohibition of 4-MBC is legally enforced, mandating that any non-compliant products be withdrawn from the market.

• Official URL: https://en.gouv.mc/

11. Principality of Andorra

• Legal Framework: National Cosmetic Standards / Harmonization with EU Regulation (EC) No 1223/2009.

• Official Mechanism: Andorra enforces domestic health laws that strictly mirror European Union standards. All cosmetics must comply with Regulation (EC) No 1223/2009. Consequently, UV filters added to the Annex II prohibited list are strictly barred from the Andorran market.

• Official URL: https://www.govern.ad/

12. Republic of Türkiye

• Legal Framework: Turkish Medicines and Medical Devices Agency (TİTCK) – Kozmetik Ürünler Yönetmeliği.

• Official Quote: "3-(4′-methylbenzylidene)-camphor kullanımı yasaklanmış Ek-II'ye eklenmiştir." (The use of 3-(4′-methylbenzylidene)-camphor is prohibited and it has been added to Annex-II).

• Official URL: https://www.titck.gov.tr/mevzuat/kozmetik-urunler-yonetmeligi

13. Ukraine

• Legal Framework: Technical Regulation on Cosmetic Products (Cabinet of Ministers Resolution).

• Official Mechanism: Ukraine’s national Technical Regulation closely mirrors EU Regulation 1223/2009, ensuring alignment with EU Annex II updates. "The UV filter 4-Methylbenzylidene Camphor (4-MBC) is entirely prohibited in cosmetic products and has been moved to Annex II."

• Official URL: https://zakon.rada.gov.ua/laws/show/65-2021-%D0%BF

14. Republic of Moldova

• Legal Framework: National Sanitary Regulation on Cosmetic Products.

• Official Mechanism: As part of its EU integration, Moldovan regulations prohibit the exact same hazardous substances banned in the EU (updating concurrently with Annex II). The European prohibition of 4-MBC is legally binding within the Moldovan market to ensure consumer safety and cross-border trade.

• Official URL: https://gov.md/

15. Republic of Serbia

• Legal Framework: Rulebook on Cosmetic Products / Harmonization with the EU acquis.

• Official Mechanism: As an EU candidate country, Serbia substantially aligns with the EU’s prohibited and restricted substances lists. The national regulatory framework integrates the updates of Annex II of the EU Cosmetics Regulation (EC) No 1223/2009, strictly restricting 4-MBC from domestic market clearances.

• Official URL: https://www.zdravlje.gov.rs/

16. Montenegro

• Legal Framework: Law on Cosmetic Products / Institute for Medicines and Medical Devices (CInMED).

• Official Mechanism: Montenegro legally mandates the harmonization of its domestic cosmetic safety limits with the European Union. Products entering the Montenegrin market are evaluated against the dynamic updates of EU Annex II, ensuring the exclusion of 4-MBC.

• Official URL: https://www.cinmed.me/

17. Republic of Albania

• Legal Framework: Ministry of Health and Social Protection / Cosmetic Products Regulation.

• Official Mechanism: To meet its EU accession requirements, Albania’s health ministry anchors its prohibited ingredient lists directly to EU safety frameworks, prohibiting active substances like 4-MBC that have been determined to be endocrine disruptors by the SCCS.

• Official URL: https://shendetesia.gov.al/

18. Republic of Kosovo

• Legal Framework: Ministry of Health / Law on Cosmetic Products.

• Official Mechanism: As a potential candidate for EU membership, Kosovo integrates European regulatory safety parameters into domestic law. Compliance with the restricted and prohibited lists outlined in EU Annexes is required to market sunscreens domestically.

• Official URL: https://msh.rks-gov.net/

19. Bosnia and Herzegovina

• Legal Framework: Entity-Level Laws (Federation of Bosnia and Herzegovina & Republika Srpska) / Rulebook on Restrictions and Bans of Chemicals.

• Official Mechanism: Bosnia and Herzegovina partially aligns with EU prohibited substance lists as part of its candidate harmonization process. Product ingredients must be verified directly against the country's entity-level laws and the Rulebook on Restrictions and Bans of Chemicals, creating a framework of practical exclusion that prevents formulations non-compliant with EU Annex II from achieving broad market access.

• Official URL: http://www.mcp.gov.ba/

20. Chile

• Legal Framework: Instituto de Salud Pública (ISP) de Chile - Listado de Ingredientes Prohibidos.

• Official Quote: "En adelante se deberán respetar los plazos publicados por la Comunidad Europea."

• Official URL: https://www.ispch.cl/anamed/cosmeticos/

21. Kingdom of Morocco

• Legal Framework: Direction du Médicament et de la Pharmacie (DMP), Circulaire N° 48 DMP/20.

• Official Mechanism: DMP circulars require cosmetic products to comply with safety principles "aligned with European standards for prohibited and restricted substances," practically restricting 4-MBC's use in registered cosmetics.

• Official URL: https://dmp.sante.gov.ma/

22. Arab Republic of Egypt

• Legal Framework: Egyptian Drug Authority (EDA) – Regulatory Rules for Cosmetics Notification.

• Official Mechanism: EDA guidelines stipulate that cosmetics must comply with "the latest updates of the European Cosmetics Regulation (EC) No 1223/2009 regarding prohibited, restricted, and permitted ingredients," effectively banning 4-MBC from sanitary clearance.

• Official URL: https://edaegypt.gov.eg/

23. Republic of Tunisia

• Legal Framework: Direction de la Pharmacie et des Médicaments (DPM) – Autorisation de Mise à la Consommation (AMC).

• Official Mechanism: "Manufacturers must provide les preuves de conformité aux normes européennes... et respecter les interdictions sur les ingrédients." This requirement ensures the rejection of formulations containing EU-banned SCCS substances.

• Official URL: http://www.dpm.tn/

24. Republic of Palau

• Legal Framework: The Responsible Tourism Education Act of 2018 (RPPL No. 10-30).

• Official Quote: "For the purposes of this chapter, 'reef-toxic sunscreen' means any sunscreen that contains... (6) 4-methyl-benzylidene camphor. The manufacture, importation, or sale of reef-toxic sunscreen is prohibited."

• Official URL: https://www.palaugov.pw/

25. State of Israel

• Legal Framework: Pharmacists Regulations (Cosmetics) / Ministry of Health Alignment with EU Standards.

• Official Mechanism: Under Israel's modernized cosmetic legislation, the Ministry of Health directly anchors domestic ingredient safety to the European Union's Cosmetics Regulation. By explicitly aligning with the dynamic updates to EU Annex II (Prohibited Substances), Israel legally ensures that endocrine-disrupting UV filters like 4-MBC restricted by the EU are similarly barred from the Israeli market.

• Official URL: https://www.gov.il/en/departments/ministry_of_health

26. United States Federal Territories (5 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: Puerto Rico, US Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.

• Legal Framework: U.S. Federal Law / FDA OTC Sunscreen Monograph.

• Official Mechanism: As territories governed by federal U.S. law, the FDA's strict positive list applies. The omission of 4-MBC legally bars it from being marketed or imported within these 5 major federal territories.

• Official URL: https://www.fda.gov/

27. French Republic – Overseas Departments and Collectivities (6 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: French Guiana (South America), Guadeloupe, Martinique, Saint-Martin (Caribbean), Mayotte, and Réunion (Indian Ocean).

• Legal Framework: Outermost Regions (OMRs) of the European Union.

• Official Mechanism: As legally integrated departments of France, the prohibition of 4-MBC applies automatically and unconditionally across these borders, extending the EU ban deeply into South America, the Caribbean, and the Indian Ocean.

• Official URL: https://ansm.sante.fr/

28. Kingdom of Spain – Outermost Region (1 Jurisdiction)

• Geographic Jurisdiction Explicitly Bound: The Canary Islands (West Africa).

• Legal Framework: Autonomous Community of Spain and EU Outermost Region.

• Official Mechanism: The EU Annex II prohibition of 4-MBC is legally binding and actively enforced throughout this archipelago off the coast of Africa.

• Official URL: https://www.aemps.gob.es/

29. Portuguese Republic – Autonomous Regions (2 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: The Azores and Madeira (North Atlantic Ocean).

• Legal Framework: Autonomous Regions of Portugal and EU Outermost Regions.

• Official Mechanism: The EU Annex II prohibition of 4-MBC flows directly into the legal systems of these fully integrated autonomous regions, barring the ingredient from being marketed or sold in these North Atlantic islands.

• Official URL: https://www.infarmed.pt/

30. Kingdom of the Netherlands – Caribbean Jurisdictions (6 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: The BES Islands (Bonaire, Sint Eustatius, Saba), Aruba, Curaçao, and Sint Maarten.

• Legal Framework: Dutch Ministry of Health, Welfare and Sport (VWS) / Alignment with EU Cosmetics Regulation (EC) No 1223/2009.

• Official Mechanism: The Dutch Caribbean operates under the sanitary frameworks of the Kingdom of the Netherlands. For cosmetics to be legally imported or registered in the special municipalities (the BES islands) or the autonomous Caribbean countries (Aruba, Curaçao, Sint Maarten), they must comply with Dutch Kingdom health standards. Because the Netherlands enforces the EU Annex II prohibited list, formulations containing 4-MBC cannot achieve the required regulatory clearance or Certificates of Free Sale to enter these 6 Caribbean markets.

• Official URL: https://www.rijksoverheid.nl/ministeries/ministerie-van-volksgezondheid-welzijn-en-sport (Dutch Ministry of Health, Welfare and Sport)

31. United Kingdom – Crown Dependencies & Overseas Territories (4 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: The Isle of Man, Jersey, Guernsey, and Gibraltar.

• Legal Framework: UK Cosmetic Products Regulations / Gibraltar post-Brexit EU alignment.

• Official Mechanism: The Crown Dependencies (Isle of Man, Jersey, Guernsey) share a strict customs and regulatory zone with the UK, directly mirroring the UK’s cosmetic bans. Meanwhile, Gibraltar explicitly retained EU cosmetic safety regulations post-Brexit. Consequently, the UK and EU prohibitions on 4-MBC flow directly into these 4 jurisdictions, making the chemical illegal to market or sell.

• Official URL: https://www.gov.im/ (Isle of Man Government) & https://www.gibraltar.gov.gi/ (HM Government of Gibraltar)

32. Kingdom of Denmark – Autonomous Territories (2 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: Greenland and the Faroe Islands.

• Legal Framework: Danish Environmental Protection Agency / EU Cosmetics Regulation.

• Official Mechanism: While Greenland and the Faroe Islands are not part of the EU, they operate as autonomous territories within the Kingdom of Denmark. They rely entirely on Danish and European safety standards for the importation and clearance of cosmetic products. Because Denmark strictly enforces the EU Annex II prohibition of 4-MBC, formulations containing the chemical are effectively blocked from achieving sanitary clearance in both North Atlantic territories.

• Official URL: https://eng.mst.dk/ (Danish Environmental Protection Agency)

33. French Republic – Overseas Collectivities (5 Jurisdictions)

• Geographic Jurisdictions Explicitly Bound: French Polynesia, New Caledonia, Wallis and Futuna (Pacific Ocean); Saint Barthélemy, Saint Pierre and Miquelon (Atlantic/Caribbean).

• Legal Framework: French National Agency for the Safety of Medicines and Health Products (ANSM).

• Official Mechanism: While these territories have varying degrees of autonomy (unlike the fully integrated French OMRs), they rely heavily on the French mainland (ANSM) for pharmaceutical and cosmetic safety clearances. To import cosmetics into these territories, products typically require a Certificate of Free Sale proving compliance with French/EU laws. Therefore, the EU prohibition of 4-MBC acts as a practical and administrative ban across France's Pacific and Atlantic collectivities.

• Official URL: https://ansm.sante.fr/

About the Australian Sunscreen Council (ASC)

The Australian Sunscreen Council (ASC) is an independent advisory and industry body dedicated to advancing the safety, efficacy, and regulatory integrity of photoprotection in Australia. Recognizing Australia’s unique environmental challenges and world-leading skin cancer incidence rates, the ASC is committed to ensuring domestic sunscreen standards reflect the most current, peer-reviewed toxicological science and international regulatory consensus.

Operating at the intersection of public health policy and dermatological science, the Council collaborates with medical professionals, formulation chemists, and global health authorities. The ASC actively promotes the modernization of Australia’s Permissible Ingredients Determination, advocating for the phase-out of legacy endocrine-disrupting chemicals