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Omnibus VI Act - New Cosmetics Regulations in the European Union

The European Commission’s Project Omnibus Act VI goes into effect on December 1st, 2023.

Omnibus VI New Regulations
23 MAY 2023 ALS

The European Commission Omnibus Act VI introduces a new prohibition on certain ingredients, specifically targeting substances classified as CMR (carcinogenic, mutagenic, or toxic for reproduction). This legislation encompasses 30 ingredients commonly utilized in cosmetics formulations, which will be explicitly prohibited in beauty and personal care products.

The Omnibus Act VI aims to accomplish Article 15 of the Cosmetics Regulation of the European Union, which also prohibits CMR substances in cosmetic products.

According to the project, from December 1st, 2023, cosmetic products containing any of the substances mentioned cannot be made available or commercialized on the European Union (EU).

 

The following substances will be prohibited for use in cosmetics:

  • ammonium bromide;
  • bis(2-dibutyltin ethylhexanoate);
  • di(dibutyltin acetate);
  • tellurium dioxide;
  • barium diboron tetroxide;
  • 2,2-dimethylpropan-1-ol, derived from tribromo; 3-bromo-2,2-bis(bromomethil)propan-1-ol;
  • 2,4,6-tri-terc-butylphenol;
  • 4,4'-sulfonyldiphenol; bisphenol S;
  • benzophenone;
  • Quinoclamine (ISO); 2-amino-3-chlorine-1,4-naphthoquinone;
  • perfluoroheptanoic acid; tridecafluoroheptanoic acid;
  • N-(isopropoxycarbonyl)-L-valil-(3RS)-3-(4-chlorophenyl)-β-methyl alaninate; valifenalate;
  • 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-il]hexanoic, sodium salts and tris(2-hidroxietil)ammonium acid;
  • 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-il]hexanoic acid;
  • 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-il]hexanoic acid
  • theophylline; 1,3-dimethyl-3,7-di-hydro-1H-purine-2,6-diona;
  • 1,3,5-triazine-2,4,6-triamine; melamine;
  • Fluopicolide (ISO); 2,6-dichlorine-N-[3-chlorine-5-(trifluoromethyl)-2-pyridylmethyl]benzamide;
  • Triamide N-(2-nitrophenyl)phosphoric;
  • N-(5-chlorine-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucipram;
  • Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-metanonaftalen-5-il]pyrazole- 4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-metanonaftalen-5-il]pyrazole-4-carboxamide [>78% of isomers sin <15% of relative content of anti-isomers]; isopyrazam;
  • Loamy, ext. Of the Azadirachta grains indicates the water extracted and afterwards, they are processed with organic solvents;
  • Cumenian;
  • Diacrylate of 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediol; acrylate of 2,2-bis(acryloyloxymethyl)butyl; triacrylate of trimethylolpropane;
  • Pentapotassium 2,2',2'',2''',2''''-(ethane-1,2-diylnitrile)pentaacetate;
  • N-carboxymethyliminobis(ethylene nitrile)tetra(Acetic Acid);
  • (carboxylatemethyl)iminobis(ethylene nitrile)tetraacetate of pentasodium;
  • Acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3-il)methyl]-N'-cyan-N-methylethanimidamide; (E)-N1-[(6-chlorine-3-pyridyl)methyl]-N2-cyan-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.

 

In November of last year, the European Commission officially notified the Commercial World Business (OMC) regarding the forthcoming prohibition discussed in this article, set to be implemented on December 1st, 2023. It is crucial for beauty brands exporting or commercializing their cosmetic products within the European Union to be aware of and comply with the regulations outlined in the Omnibus Act VI. By doing so, these brands can ensure adherence to the new standards and maintain their presence in the European market.

 

More information on the Omnibus Act VI can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0692

 

 

 
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