The European Union has just published Regulation (EU) 2026/78, the eighth annual text aimed at banning or regulating substances recently classified as CMR. It transposes the 22nd ATP of the CLP Regulation into the Cosmetics Regulation and is applicable on the same date: May 1, 2026.
The key points of Regulation (UE) 2026/78
• This text transposes the classification of substances as carcinogenic, mutagenic or toxic to reproduction (CMR), adopted in Delegated Regulation (EU) 2024/2564 (22nd ATP of CLP).
• 15 substances are added to Annex II (Prohibited substances) of European Cosmetics Regulation 1223/2009. One of these has an INCI name: N,N’-Methylenebisacrylamide.
• Silver is now banned in its massive and nano forms, but permitted in its powder form with restrictions (0.05% in toothpastes and mouthwashes) and as a colorant (0.2% in lip products and eye shadows).
• Hexyl Salicylate is added to Annex III, with different maximum authorized concentrations depending on product type.
• Sodium o-Phenylphenate joins o-Phenylphenol in Annex V of authorized preservatives, at the same maximum concentrations as the latter.
• The Regulation will come into force on 1st May, 2026.
The “Whereas” of Regulation (UE) 2026/78
(1) Regulation (EC) No.1272/2008 of the European Parliament and of the Council provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific assessment by the Committee for Risk Assessment of the European Chemicals Agency. The substances are classified as CMR substances of category 1A, …
