[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From this date, non-compliant cosmetic products may no longer be placed or made available on the EU market and must be withdrawn prior to enforcement.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?
Our regulatory team is here to help you navigate these changes and safeguard your compliance strategy, Get in touch today.

Subscribe to our updates to stay informed on future regulatory developments impacting the cosmetics sector.

Share This Story, Choose Your Platform!

Related Posts

    • Navigate Global Cosmetic Compliance with Confidence: How Melbec Microbiology Supports Your Brand Worldwide

      Published On: August 25, 2026

      Bringing a cosmetic product to market is challenging enough, but launching it globally adds an entirely new layer of regulatory complexity. Every region has its own safety standards, documentation requirements, banned ingredient lists, and consumer [...]

    • Plastic Free July: How Microbiology and Melbec Are Helping Shape a More Sustainable Future

      Published On: July 15, 2026

      Every year, Plastic Free July invites individuals and businesses to rethink their relationship with single‑use plastics. It’s a global movement that empowers millions to reduce plastic pollution and adopt more sustainable habits. But in the [...]

    • [Canada] Amendments to Hot List

      Published On: July 14, 2026

      The following amendments have been made to Canada’s Hot List. Substance Restriction/proposition PHMB ( Polyaminopropyl Biguanide)    Restriction: (Polyhexamethylenebiguanide; Poly(hexamethylenebiguanide) hydrochloride; PHMB; Polihexanid)   Not permitted for use in spray or aerosol formulations. Max concentration for [...]