Omnibus Act VII: new substances officially banned in the EU from September 2025

Today, 13 May 2025, the Official Journal of the EU released Commission Regulation (EU) 2025/877. This Regulation covers substances classified as carcinogenic, mutagenic or toxic for reproduction substances (CMR). In the EU Cosmetics Regulation, CMR substances should be included in the list of prohibited substances (Annex II) and, where relevant, deleted from the lists of restricted or allowed substances (Annexes III to VI). This means that some CMR substances could be used in cosmetic products according to the restrictions specified in Annexes III, IV, V, and VI.

Today’s publication officially amends Annex II and III.

The bans apply from 1 September 2025. There is no differences between placing on the market and making available on the market. Consequently, from 1 September 2025 non-compliant cosmetics cannot be sold on the EU market anymore and must be recalled before.

Updated list of CMR substances banned in the EU

The following substances are added to Annex II (list of banned substances for use in cosmetics):

  • diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (75980-60-8). This substance is currently part of Annex III (restricted or allowed substances). However, with this update, the substance is removed from Annex III and thus, no longer allowed in cosmetics, also when restricted.
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisphenol-A (79-94-7)
  • transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate (118712-89-3)
  • clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5- ylmethyl)-3-methyl-2-nitroguanidine (210880-92-5)
  • benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate (577705-90-9)
  • benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1) (75768-65-9)
  • 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 (18755-43-6)
  • dibutyltin maleate (78-04-6)
  • dibutyltin oxide (818-08-6)
  • 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 (1478-61-1)
  • benfluralin (ISO); N-butyl-N-ethyl-α,α,αtrifluoro-2,6-dinitro-p-toluidin (1861-40-1)
  • N,N-dimethyl-p-toluidine (99-97-8)
  • 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs (68953-84-4)
  • 4-nitrosomorpholine (59-89-2)
  • 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 (119446-68-3)
  • 4-methylimidazole (822-36-6)
  • 3,3′-dimethylbiphenyl-4,4′-diyl diisocyanate (91-97-4)
  • 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 (173159-57-4)
  • cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide (57966-95-7)
  • (2E)-2-cyano-N-[(ethylamino)carbonyl]-2- (methoxyimino)acetamide (166900-80-7)

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