Omnibus Act VI is officially published!

July 20, 2023

The official act

Today, July 20, 2023, the European Commission published Commission Regulation (EU) 2023/1490, namely Omnibus Act VI.

The law prohibits the use of the CMR substances classified as such in 2022 adding 30 new entries to Annex II to the EU Cosmetics Regulation. As anticipated in our previous article, these bans will apply as of December 1, 2023.

Therefore, beauty brands have a few months to ensure compliance with the new requirements and to sell the existing stocks. As of December 1, 2023, non-compliant products must be sold or, otherwise, recalled from the EU market.

The newly banned substances are:

• Ammonium bromide;
• Dibutyltin bis(2-ethylhexanoate);
• Dibutyltin di(acetate);
• Tellurium dioxide;
• Barium diboron tetraoxide;
• 2,2-dimethylpropan-1-ol,tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol;
• 2,4,6-tri-tert-butylphenol;
• 4,4’-sulphonyldiphenol; bisphenol S;
• Benzophenone;
• Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone;
• Perfluoroheptanoic acid; tridecafluoroheptanoic acid;
• methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate;
• 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts;
• 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid;
• 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid;
• Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione;
• 1,3,5-triazine-2,4,6-triamine; melamine;
• Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide;
• N-(2-nitrophenyl)phosphoric triamide;
• N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram;
• Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [>78% syn isomers <15% anti isomers relative content]; isopyrazam;
• Margosa, ext. from the kernels of Azadirachta indica extracted with water and further processed with organic solvents;
• Cumene;
• 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate;
• Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate;
• N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid);
• Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate;
• Acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3-yl)methyl]-N’-cyano-N-methylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine;
• Pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene;
• Bentazone (ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide.

 

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References:

European Commission. (2023). Commission Regulation (EU) 2023/1490 of 19 July 2023 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 20/07/2023