New substances will be banned in cosmetics in the EU from 1 September 2025 – Omnibus Act VII

Yesterday, June 24, 2024, the European Commission notified the World Trade Organization (WTO) of a draft regulation amending the use of certain CMR substances in cosmetic products. It is the draft of Omnibus Act VII which aims at implementing Commission Regulation (EU) No 2024/197 in the EU Cosmetics Regulation. Commission Regulation (EU) No 2024/197 introduced newly classified CMR substances into the EU CLP Regulation.

Omnibus Act VII will apply as of September 1, 2025, and there will be no differences between placing on the market and making available on the market. It means that, as of the application date, non-compliant cosmetics cannot be sold on the EU market anymore and must be recalled before.

Substances soon-to-be banned

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

  • diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide – which is currently restricted under Annex III to the EU Cosmetics Regulation
  • 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

The industry did not submit any requests for using these substances in cosmetic products by way of exception.

What to do now

Even though this is just a draft, it is already time to act because Omnibus Act VII and Commission Regulation (EU) No 2024/197 apply as of the same date with no exceptions.

If you are a cosmetic brand, you should reach out to your producers and check whether any of your products contain the ingredients listed above. If so, you will have to proceed with the reformulation and all necessary steps to ensure compliance, including an updated safety assessment report and CPNP notification. In any case, we invite you to contact your EU Responsible Person as soon as possible as it can support you along the process.

Do you need any help or additional information? Contact us today!

 

References:
  • WTO. (2024). Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 24/06/2024
  • WTO. (2024). Draft Annex to the Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetics products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction. Retrieved on 24/06/2024

 

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