On June 24, 2024, the European Commission announced plans to introduce significant changes regarding the use of CMR substances (carcinogenic, mutagenic, or toxic to reproduction) in cosmetics within the European Union. The project, named Omnibus Act VII, aims to align EU cosmetic regulations with the latest safety standards, taking into account Commission Regulation (EU) No 2024/197.
🔹 What Does Omnibus Act VII Mean? 🔹
Omnibus Act VII announces changes in the classification and use of CMR substances in cosmetics, effective from September 1, 2025. From this date, all cosmetic products introduced to the EU market must comply with the new safety standards, eliminating the difference between the introduction of products and their availability.
🔹 Key Points of the New Regulations 🔹
🔹 Commission Regulation (EU) No 2024/197: The new regulations incorporate newly classified CMR substances into the EU CLP Regulation, aiming to increase transparency and safety of cosmetic products.
🔹 Effective Date: The changes will take effect on September 1, 2025, meaning that non-compliant cosmetics must be withdrawn from the EU market.
🔹Uniform Conditions for Introduced Products: From the effective date of Omnibus Act VII, all cosmetics available on the EU market must meet the new safety requirements, regardless of when they were introduced.
🔹 Impact on the Cosmetic Industry 🔹
The new regulations will have a significant impact on the cosmetic sector, requiring manufacturers to conduct thorough analyses and potentially modify product formulations. For businesses, this means the necessity to adapt to the new requirements to avoid issues related to product withdrawal from the market.
Among the prohibited substances are:
🔹 diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide – currently restricted for use in accordance with Annex III of the EU Cosmetics Regulation
🔹 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisfenol-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, sól z 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)
🔹4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol i benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1)
🔹 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol i benzyltriphenylphosphonium, sól z 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)
🔹dimethyl propylphosphonate
🔹dibutyltin maleate
🔹dibutyltin oxide
🔹 1-(2,3-epoxypropoxy)-2,2-bis((2,3-epoxypropoxy)methyl)butane i 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’-mieszane pochodne Ph i tolyl
🔹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′-diizocyjanian
🔹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
