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Commission Regulation (EU) 2026/78 (Omnibus VIII)

Substances newly classified as CMR under the CLP Regulation are prohibited, and the silver entry now covers the massive form as well as nano. Silver powder is restricted to toothpaste and mouthwash at 0.05% and to lip products and eyeshadow as a colourant at 0.2%; hexyl salicylate gets limits by product category, from 0.001% in toothpaste and mouthwash to 2% in hydroalcoholic fragrances. Sodium o-phenylphenate joins o-phenylphenol in Annex V under a combined limit, with no use in oral products.

PublishedOfficial Journal, 13 January 2026
Comments to
Applies1 May 2026
Off the marketNo separate date: products on the market must comply from 1 May 2026
Annexes

Annex II · 15 entries added, 1752–1766; entry 1727 now covers silver in nano and massive form

Annex III · silver powder and hexyl salicylate, entries 379 and 380 as inserted by this regulation

Annex IV · silver powder as colourant, entry 142

Annex V · o-phenylphenol and sodium o-phenylphenate

EUR-Lex, Regulation (EU) 2026/78

Entered 

01/Substances

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SubstanceCASAnnex entryChange

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