[EU] Omnibus Act VII

The EU Omnibus Act VII, implementing Commission Regulation (EU) No 2024/197, introduces newly classified CMR (Carcinogenic, Mutagenic or Reprotoxic) substances into Annex II of the EU Cosmetics Regulation (EC No 1223/2009).

Effective Date:

  • 1 September 2025
  • From this date, non-compliant cosmetic products may no longer be placed or made available on the EU market and must be withdrawn prior to enforcement.

The following substances will be added to Annex II, the list of banned substances for use in cosmetic products:

  • Trimethylbenzoyl diphenylphosphine oxide (TPO)– currently – is listed in entry 311 of Annex III to Regulation (EC) No 1223/2009 and is, therefore, allowed for professional use in artificial nail systems with a maximum concentration of 5%.
  • Dimethyltolylamine- carcinogenic 1B – no EU Cosmetic regulation Annex entry.
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisphenol-A.
  • transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate.
  • clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5- ylmethyl)-3-methyl-2-nitroguanidine.
  • benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate.
  • benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1).
  • reaction mass of 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate (1:1).
  • reaction mass of 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1).
  • dimethyl propylphosphonate.
  • dibutyltin maleate.
  • dibutyltin oxide.
  • reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3- epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2- hydroxymethyl butane.
  • 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol; bisphenol AF.
  • benfluralin (ISO); N-butyl-N-ethyl-α,α,αtrifluoro-2,6-dinitro-p-toluidin.
  • N,N-dimethyl-p-toluidine.
  • 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.
  • 4-nitrosomorpholine.
  • difenoconazole (ISO); 1-({2-[2-chloro-4-(4- chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2- yl}methyl)-1H-1,2,4-triazole; 3-chloro-4- [(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4- triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4- chlorophenyl ether.
  • 4-methylimidazole.
  • 3,3′-dimethylbiphenyl-4,4′-diyl diisocyanate.
  • foramsulfuron (ISO); 2-{[(4,6- dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}- 4-formamido-N,N-dimethylbenzamide; 1-(4,6- dimethoxypyrimidin-2-yl)-3-(2- dimethylcarbamoyl-5- formamidophenylsulfonyl)urea.
  • (2E)-2-cyano-N-[(ethylamino)carbonyl]-2- (methoxyimino)acetamide.

Act Now to Ensure Compliance by 1 September 2025

The inclusion of newly classified CMR substances in Annex II of the EU Cosmetics Regulation marks a critical regulatory shift. From 1 September 2025, cosmetic products containing these banned substances must be withdrawn from the EU market.

✅ Review your product formulations
✅ Update regulatory documentation
✅ Coordinate with suppliers and manufacturers
✅ Ensure market readiness before enforcement begins

Need expert support?
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