,On January 13, 2026, the European Commission of the European Union published Commission Regulation (EU) 2026/78 in the Official Journal, amending Regulation (EC) No 1223/2009 on cosmetic products regarding CMR substances. This regulation integrates new CMR classifications from Delegated Regulation (EU) 2024/2564, prohibiting most substances while granting exemptions for safe uses based on SCCS opinions. It merges perborate entries for clarity, restricts silver forms to mitigate nano-risks, and adds limits for fragrances and preservatives. The approach ensures health protection, market uniformity, and legal simplification, applying from May 1, 2026, across the EEA. Perboric Acid and Salts (Annexe II, Entry 1397 - Prohibited): Chemical Names: Perboric acid (H3BO2(O2)), monosodium salt trihydrate, etc., including Trimethyl borate. CAS Nos.: 13517-20-9 to 121-43-7. EC Nos.: 239-172-9 to 204-468-9. Use: Grouped prohibition in cosmetics due to CMR 1B and hydrogen peroxide release; entries 1398/1399 deleted. Silver (Annexe II Entry 1727 - Prohibited; Annexe III Entry 379 - Restricted; Annexe IV Entry 142 - Allowed): Chemical Names: Silver (nano/massive/powder). CAS No.: 7440-22-4. EC No.: 231-131-3. Use: Nano/massive banned; powder restricted to 0.05% in toothpaste/mouthwash; allowed as colourant (CI 77820) at 0.2% in lip/eye products per SCCS/1665/24. Hexyl 2-Hydroxybenzoate (Annexe III Entry 380 - Restricted): Chemical Name: Hexyl Salicylate. CAS No.: 6259-76-3. EC No.: 228-408-6. Use: Restricted concentrations (0.001%-2%) in fragrances, rinse-off/leave-on products, toothpaste; limits for children <3 years per SCCS/1668/24. Biphenyl-2-ol and Sodium Salt (Annexe V Entry 7 - Allowed): Chemical Names: o-Phenyl phenol; Sodium o-Phenyl phenate. CAS Nos.: 90-43-7; 132-27-4. EC Nos.: 201-993-5; 205-055-6. Use: Preservative at 0.2%/0.15% (as phenol) in rinse-off/leave-on; combined limits, no inhalation/oral use per SCCS/1669/24. Other Prohibited Substances (Annexe II Entries 1752-1766): Examples: Multi-walled Carbon Tubes (no CAS/EC); Acetone oxime (CAS 127-06-0, EC 204-820-1); up to Pyraclostrobin (CAS 175013-18-0, no EC). Banned without exemptions, this binding regulation prioritises health via uniform CMR bans/exemptions.
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