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  • Writer's pictureDaniel Jiménez

The Omnibus Act VII: New Restrictions for CMR Substances in Cosmetic Products

On June 24, 2024, the European Commission notified the World Trade Organization (WTO) of a draft regulation amending the use of certain carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in cosmetic products.

This draft, known as the Omnibus Act VII, aims to implement Commission Regulation (EU) No 2024/197 into the EU Cosmetics Regulation, introducing newly classified CMR substances according to the EU CLP Regulation.

The Omnibus Act VII: New Restrictions for CMR Substances in Cosmetic Products
The Omnibus Act VII: New Restrictions for CMR Substances in Cosmetic Products

The Omnibus Act VII: Implementation and Compliance

The Omnibus Act VII will come into effect on September 1, 2025, eliminating any distinction between marketing and placing products on the market. From this date, cosmetics that do not comply with these new standards must be withdrawn from the EU market.

Annex II: Aggregated Prohibited Substances

The following substances will be added to Annex II of the EU Cosmetics Regulation, prohibiting their use in cosmetic products:

diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide: it 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
1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs
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
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

Impact on the Cosmetic Industry

Although these substances are not widely known and their use in cosmetics is limited, implementing these new restrictions underscores the EU's commitment to consumer safety.

On platforms like Cosmedesk, none of these ingredients are included, ensuring that products listed there comply with the new regulations.

Official Sources and Summary

For more information, you can consult the following official links:

The Omnibus Act VII, effective from September 1, 2025, will ban the use of CMR substances in cosmetic products according to Regulation (EU) No 2024/197. This measure is crucial to align cosmetic regulations with the latest classifications of hazardous substances, ensuring the safety of products available in the EU market.

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