The Global Consensus: A Worldwide Rejection of 4-MBC by 95 Nations
- Australian Sunscreen Council
- 12 minutes ago
- 14 min read
With 4-MBC legally prohibited across Europe, now unlawful to supply at any point in the European chain, banned by name across the Gulf, systematically erased from major export markets in Asia, Latin America, and Africa, prohibited in Great Britain, and unapproved by the US FDA and Japan's MHLW, the international consensus is clear. In total, 4-MBC is now actively prohibited across 95 nations and 31 overseas territories, representing 126 distinct geographic jurisdictions worldwide.
This is an update to our May 2026 review.
Comprehensive List of 127 Jurisdictions Restricting or Prohibiting 4-MBC
(August 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. Of the 127 jurisdictions listed, 89 rest on a sighted binding instrument, a sighted closed positive list, or a sighted incorporation clause; these carry an Official Quote. The remainder rest on documented regulatory alignment and carry an Official Mechanism describing how the restriction operates in practice.
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. EEA Joint Committee Decision No 209/2024 of 23 September 2024 incorporates the 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: Prohibition on placing on the market effective 1 May 2025. Prohibition on making available — supply at any point in the chain — effective 1 May 2026. The sell-through period has now closed.
Official URL: https://eur-lex.europa.eu/eli/reg/2024/996/oj
2. The Gulf Cooperation Council (7 Nations)
Countries Explicitly Bound: Saudi Arabia, United Arab Emirates, Bahrain, Kuwait, Oman, Qatar, Yemen.
Legal Framework: GSO 1943:2024, Gulf Technical Regulation — Cosmetic Products, Safety Requirements of Cosmetics and Personal Care Products, Annex II (List of Substances Prohibited in Cosmetic Products).
Official Mechanism: GSO 1943:2024 is a binding Gulf technical regulation adopting the annex structure of Regulation (EC) No 1223/2009, given effect through each member state's national standards body and enforced at import. The Saudi Food and Drug Authority applies it directly to cosmetic notification.
Official URL: https://www.gso.org.sa/
3. ASEAN / Southeast Asian Nations (11 Nations)
Countries Explicitly Bound: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Timor-Leste.
Legal Framework: ASEAN Cosmetic Directive (ACD), Annex II entry 1723; Annex VII reference 18 deleted. Updated by ASEAN Cosmetic Committee resolution.
Official Quote: "ASEAN Cosmetic Directive Annex II entry 1723 (CAS 36861-47-9 / 38102-62-4); Annex VII ref 18 entry deleted."
Official Mechanism: The ACD annexes were adopted from a fixed European text and are amended by ASEAN Cosmetic Scientific Body decision. The current annex names the substance directly. Timor-Leste applies the ASEAN cosmetic framework as an acceding member state.
Official URL: https://asean.org/our-communities/economic-community/standards-and-conformance/
4. 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 Standards EAS 377-1:2022 (List of substances prohibited in cosmetic products) and EAS 377-3:2022 (List of allowed colorants, preservatives and UV filters), adopted under the EAC Standardisation, Quality Assurance, Metrology and Testing Act 2006.
Official Quote: "Within six months of the declaration of an East African Standard, the Partner States shall adopt, without deviation from the approved text, the East African Standard as a national standard and withdraw any existing national standard with similar scope and purpose." — SQMT Act 2006, s.15(1)
Official Mechanism: EAS 377-1 cl.4 refers to EU Regulation 1223/2009 Annex II as amended from time to time. The statutory adoption obligation makes the standard binding on all eight Partner States without further national action.
Official URL: https://catalog.easc.org/
5. 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), adopted by COMIECO Resolution 474-2023.
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 "y sus actualizaciones" — and its updates — legally binds these 6 nations to the EU prohibition.
Official URL: https://www.sieca.int/
6. The United Kingdom (Great Britain and Northern Ireland – 2 Jurisdictions)
Jurisdictions Explicitly Bound: Great Britain (England, Scotland, Wales); Northern Ireland.
Legal Framework: Assimilated Regulation (EC) No 1223/2009 as amended by SI 2026/23, adding 4-MBC to Annex II for Great Britain. 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."
Implementation Deadline: No placing on the Great Britain market from 15 July 2026; existing stock saleable until 14 January 2027. Northern Ireland follows the EU timetable.
Official URL: https://www.gov.uk/guidance/submit-a-cosmetic-product-notification
7. United States of America
Legal Framework: U.S. Food and Drug Administration (FDA) – OTC Sunscreen Monograph, 21 CFR 352.
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/
8. Japan
Legal Framework: Ministry of Health, Labour and Welfare (MHLW) – Standards for Cosmetics, Notification No. 331 of 2000.
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/
9. The People's Republic of China
Legal Framework: National Medical Products Administration (NMPA) Announcement No. 6 of 2026, dated 7 January 2026 and published 12 January 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."
Implementation Deadline: Six of the eighteen incorporated standards take effect 1 January 2027; the remaining twelve 1 January 2028. Products manufactured or imported before the effective date may be sold to end of shelf life.
Official URL: https://www.nmpa.gov.cn/xxgk/ggtg/hzhpggtg/hzhpcpggtg/
10. 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
11. Svalbard
Legal Framework: Forskrift om kosmetikk og kroppspleieprodukter (FOR-2013-04-08-391), extended to Svalbard by FOR-2015-06-22-747.
Official Quote: "Forskrifter med hjemmel i kosmetikklova gjelder for Svalbard." (Regulations made under the Cosmetics Act apply to Svalbard.) — FOR-2015-06-22-747, s.13
Official Mechanism: Article 126 of the EEA Agreement excludes Svalbard from the EEA's territorial scope. The prohibition therefore arrives not through the EEA but through Norwegian domestic extension of the national cosmetics regulation, which itself incorporates Regulation (EC) No 1223/2009.
Official URL: https://lovdata.no/dokument/SF/forskrift/2013-04-08-391
12. 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 enforced, mandating that any non-compliant products be withdrawn from the market.
Official URL: https://en.gouv.mc/
13. Principality of Andorra
Legal Framework: National Cosmetic Standards / Harmonization with EU Regulation (EC) No 1223/2009.
Official Mechanism: Andorra enforces domestic health laws that mirror European Union standards, under an EU customs union for industrial goods. All cosmetics must comply with Regulation (EC) No 1223/2009. Consequently, UV filters added to the Annex II prohibited list are barred from the Andorran market.
Official URL: https://www.govern.ad/
14. Ukraine
Legal Framework: Technical Regulation on Cosmetic Products (Cabinet of Ministers Resolution No. 65 of 2021).
Official Mechanism: Ukraine's national Technical Regulation closely mirrors EU Regulation 1223/2009, ensuring alignment with EU Annex II updates.
Official URL: https://zakon.rada.gov.ua/laws/show/65-2021-%D0%BF
15. Republic of Moldova
Legal Framework: National Sanitary Regulation on Cosmetic Products.
Official Mechanism: As part of its EU integration, Moldovan regulations prohibit the substances banned in the EU. The European prohibition of 4-MBC is applied within the Moldovan market to ensure consumer safety and cross-border trade.
Official URL: https://gov.md/
16. 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, integrating updates to Annex II of Regulation (EC) No 1223/2009.
Official URL: https://www.zdravlje.gov.rs/
17. Montenegro
Legal Framework: Law on Cosmetic Products / Institute for Medicines and Medical Devices (CInMED).
Official Mechanism: Montenegro harmonizes domestic cosmetic safety limits with the European Union. Products entering the Montenegrin market are evaluated against EU Annex II.
Official URL: https://www.cinmed.me/
18. Republic of Albania
Legal Framework: Ministry of Health and Social Protection / Cosmetic Products Regulation.
Official Mechanism: To meet EU accession requirements, Albania anchors its prohibited ingredient lists to EU safety frameworks, prohibiting substances determined by the SCCS to be endocrine disruptors.
Official URL: https://shendetesia.gov.al/
19. 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 EU Annexes is required to market sunscreens domestically.
Official URL: https://msh.rks-gov.net/
20. 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, 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/
21. Georgia
Legal Framework: EU–Georgia Association Agreement / Deep and Comprehensive Free Trade Area approximation commitments.
Official Mechanism: Georgia has committed under the Association Agreement to approximate its technical regulations to the EU acquis, including cosmetics. Products are assessed against EU ingredient restrictions for market clearance.
Official URL: https://www.moh.gov.ge/
22. 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/
23. 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. Note that Morocco's underlying arrêté refers to Council Directive 76/768/EEC, repealed in 2013; the reference is therefore static rather than dynamic, and the restriction operates in practice rather than by automatic incorporation.
Official URL: https://dmp.sante.gov.ma/
24. 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 barring 4-MBC from sanitary clearance.
Official URL: https://edaegypt.gov.eg/
25. 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, ensuring the rejection of formulations containing EU-banned SCCS substances.
Official URL: http://www.dpm.tn/
26. Western Sahara
Legal Framework: Moroccan administrative framework as applied in the territory.
Official Mechanism: Cosmetic products entering the territory are subject to the same DMP clearance requirements as the Moroccan market, extending the practical restriction of 4-MBC.
Official URL: https://dmp.sante.gov.ma/
27. Republic of South Africa
Legal Framework: CTFA Compendium of Cosmetic Ingredient Composition (January 2025), applied under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972.
Official Quote: CTFA Compendium Annex VI, "List of UV Filters Allowed in Cosmetic Products", reference number 18 — "3-(4-Methylbenzylidene)-d1 camphor / Enzacamene", CAS 38102-62-4 / 36861-47-9, 4 % — shown struck through. The list runs 16, 17, 18 (deleted), 20, 21, mirroring the gap in the current EU Annex VI.
Official Mechanism: The Compendium is the industry standard to which South African formulators work and is maintained in alignment with the EU annexes. It is not a statutory instrument, and the regulations in force under Act 54 of 1972 contain no UV-filter positive list. The restriction is therefore practical rather than legislative.
Official URL: https://ctfa.co.za/compendium/
28. State of Israel
Legal Framework: Pharmacists Regulations (Cosmetics), 5783-2023 / Ministry of Health alignment with EU standards.
Official Mechanism: Israel's modernized cosmetic legislation anchors domestic ingredient safety to the European Union's Cosmetics Regulation, ensuring that endocrine-disrupting UV filters restricted by the EU are similarly barred from the Israeli market.
Official URL: https://www.gov.il/en/departments/ministry_of_health
29. Hashemite Kingdom of Jordan
Legal Framework: Jordan Standards and Metrology Organization (JSMO) – Cosmetic Products Technical Regulation.
Official Mechanism: The Jordanian technical regulation adopts the European prohibited-substances list, with automatic effect for subsequent European amendments.
Official URL: https://www.jsmo.gov.jo/
30. Lebanese Republic
Legal Framework: Ministry of Public Health – cosmetic registration requirements.
Official Mechanism: Lebanese cosmetic registration requires conformity with the European prohibited and permitted ingredient lists, barring 4-MBC from market clearance.
Official URL: https://www.moph.gov.lb/
31. State of Palestine
Legal Framework: Ministry of Health – cosmetic registration, applying adopted European ingredient annexes.
Official Mechanism: 4-MBC is not among the UV filters approved for registration.
Official URL: https://www.moh.gov.ps/
32. 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 Mechanism: Palau is the only jurisdiction listed here to have banned 4-MBC by name on environmental rather than human-health grounds, and one of the few to prohibit its manufacture as well as its sale.
Official URL: https://www.palaugov.pw/
33. Republic of the Marshall Islands
Legal Framework: Reef-safe sunscreen legislation prohibiting listed UV filters by name.
Official Mechanism: 4-MBC is named among the prohibited filters, barring importation and sale.
Official URL: https://rmiparliament.org/
34. Republic of Cabo Verde
Legal Framework: National regulation incorporating EU Regulation (EC) No 1223/2009.
Official Mechanism: Cabo Verde's cosmetic framework incorporates the European annexes by reference, giving direct effect to the Annex II prohibition.
Official URL: https://www.minsaude.gov.cv/
35. Dominican Republic
Legal Framework: Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) — Reglamento Técnico que regula la Comercialización de Productos Cosméticos, de Higiene Personal y del Hogar, Resolución Núm. 0017-2025 (September 2025).
Official Quote: "La Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) adopta como referencias directas los listados internacionales sobre ingredientes en productos cosméticos, de higiene personal y del hogar, junto con sus respectivas funciones, restricciones o condiciones de uso… Listados de ingredientes de la Unión Europea. La base de datos europea CosIng. Las recomendaciones sobre la seguridad de los ingredientes cosméticos que emita el Comité Científico de Seguridad de los Consumidores (SCCS) de Europa."
Official Quote: "El solicitante no podrá optar por la autorización de la NSO, cuando uno de los ingredientes del producto que se pretende autorizar no esté incluido en las listas de referencia indicadas en el punto 9 del presente Reglamento. Tampoco se podrá optar por una autorización de la NSO, cuando uno de los ingredientes esté prohibido dentro del Listado oficial de ingredientes prohibidos y restringidos…"
Official Mechanism: DIGEMAPS adopts the European Union's ingredient lists, the CosIng database, and SCCS opinions as direct references. The Notificación Sanitaria Obligatoria — mandatory for legal importation, manufacture or commercialisation — cannot be granted where an ingredient is absent from those reference lists, nor where it appears on the prohibited list. Because 4-MBC was deleted from EU Annex VI and added to Annex II by Regulation (EU) 2024/996, it fails on both limbs: it is no longer among the permitted UV filters, and it is expressly prohibited. This is an administrative prohibition operating through mandatory international safety harmonisation.
Official URL: https://repositorio.msp.gob.do/bitstream/handle/123456789/2380/MISPAS_RCVS_NRT_202509_9789945659078.pdf
36. Republic of San Marino
Legal Framework: Customs union with the European Union / national health standards.
Official Mechanism: San Marino's customs union with the EU and reliance on Italian supply chains mean cosmetics on the Sammarinese market must meet EU requirements.
Official URL: https://www.sanita.sm/
37. Vatican City State
Legal Framework: Monetary and customs arrangements with the European Union / Italian supply chain.
Official Mechanism: Cosmetics available in Vatican City are supplied through the Italian market and are subject to EU Annex II compliance.
Official URL: https://www.vaticanstate.va/
38. 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/
39. United States – State-Level Statutes (3 Jurisdictions, counted within the federal position)
Geographic Jurisdictions: Hawaii, Florida (Key West), California.
Legal Framework: State reef-protection statutes restricting named UV filters, operating alongside the federal GRASE position.
Official Mechanism: These states have enacted their own restrictions on chemical UV filters. They are noted for completeness and are not counted separately in the 127 total, which already includes the United States federally.
Official URL: https://www.capitol.hawaii.gov/
40. 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, under Article 349 of the Treaty on the Functioning 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/
41. 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/
42. 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/
43. 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 EU purposes these territories are Overseas Countries and Territories, so EU cosmetics law does not apply of its own force; the restriction operates through the Dutch supply chain. Formulations containing 4-MBC cannot obtain the Certificates of Free Sale required to enter these 6 Caribbean markets.
Official URL: https://www.rijksoverheid.nl/ministeries/ministerie-van-volksgezondheid-welzijn-en-sport
44. 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 share a customs and regulatory zone with the United Kingdom, mirroring the UK's cosmetic bans. Gibraltar retained EU cosmetic safety standards post-Brexit. The UK and EU prohibitions on 4-MBC therefore flow into these 4 jurisdictions.
Official URL: https://www.gov.im/ & https://www.gibraltar.gov.gi/
45. 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: Greenland and the Faroe Islands are not part of the EU but operate as autonomous territories within the Kingdom of Denmark, relying on Danish and European safety standards for the importation and clearance of cosmetic products. Formulations containing 4-MBC are effectively blocked from sanitary clearance in both North Atlantic territories.
Official URL: https://eng.mst.dk/
46. 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: These territories are Overseas Countries and Territories for EU purposes rather than integrated OMRs, so EU law does not apply automatically. They rely on the French mainland for cosmetic safety clearances, and importation typically requires a Certificate of Free Sale proving compliance with French and EU law. The EU prohibition of 4-MBC therefore acts as a practical and administrative bar across France's Pacific and Atlantic collectivities.
Official URL: https://ansm.sante.fr/
Türkiye — the class precedent is already in force
Our May 2026 review counted Türkiye. We have removed it from the count, as they have only banned the same in class chemical 3-BC. 4-MBC ban is expected to be banned by 2028 with the next EU allignment.
About the Australian Sunscreen Council
The Australian Sunscreen Council (ASC) is the peak industry body for Australian sunscreen dedicated to advancing the safety, efficacy, and regulatory integrity of photoprotection in Australia. Recognising Australia's unique environmental challenges and world-leading skin cancer incidence rates, the Australian Sunscreen Council is committed to ensuring domestic sunscreen standards reflect the most current, peer-reviewed toxicological science and international regulatory consensus.
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