Cosmetics: Regulation (EU) 2026/78 aligns the annexes with new CMR classifications — silver only in powder form (toothpaste and mouthwash up to 0.05%), hexyl salicylate limits from 0.001% to 2%, new bans — from 1 May 2026
Commission Regulation (EU) 2026/78 of 12 January 2026, published on 13 January, amends Annexes II, III, IV and V to Regulation (EC) No 1223/2009 in view of substances classified as CMR by Delegated Regulation (EU) 2024/2564. It applies from 1 May 2026 — the same date as those classifications.
- Silver (CAS 7440-22-4) was classified as CMR category 2 in massive form (particles ≥ 1 mm), powder (100 nm – 1 mm) and nano form (1–100 nm). The nano and massive forms are banned; the powder is allowed as an ingredient of toothpaste and mouthwash up to 0.05% and as the colorant CI 77820 in lip products and eye shadows up to 0.2% — in line with a 2024 SCCS opinion.
- Hexyl salicylate was added to Annex III with limits: hydroalcoholic fragrances 2%, rinse-off products 0.5%, leave-on products 0.3%, toothpaste and mouthwash 0.001%, certain products for children under 3 years 0.1%. o-Phenylphenol and the newly permitted sodium o-phenylphenate as preservatives: 0.2% in rinse-off and 0.15% in leave-on products (as phenol), also combined; not in oral products.
- Fifteen new prohibited entries were added to Annex II, including multi-walled carbon nanotubes of a defined geometry, acetone oxime, 1,4-dichloro-2-nitrobenzene, N,N’-methylenediacrylamide, S-metolachlor, pyraclostrobin and fenpropidin; the entries for perboric acid and its salts were merged into one group.
- Complife Group points out that the Regulation provides no sell-through period: non-compliant products had to be withdrawn from the market by 1 May 2026, and manufacturers should confirm the particle size of silver and update the PIF and CPSR safety reports.