top of page
Writer's pictureDaniel Jiménez

Omnibus VI Act - New Cosmetics Regulations in the European Union


The new regulation known as Omnibus VI will start to apply on December 1, 2023. It is important for cosmetic brands to comply with the Omnibus VI regulations in order to maintain their presence in the European market.

This new ingredient ban based on Omnibus Law VI adopted by the European Commission follows a scientific and practical concern regarding chemicals known as CMRs. These substances are characterized by their carcinogenic, mutagenic or reproductive toxicity potential.


The legislation covers thirty common ingredients used in cosmetic formulations, which will be explicitly prohibited from inclusion in beauty and personal care products. The main objective of this measure is to comply with Article 15 of the European Union Cosmetics Regulation, which prohibits the presence of CMR substances in cosmetic products.


Under this draft, it is established that as of December 1, 2023, cosmetic products containing any of the aforementioned substances may not be available or marketed in the European Union (EU). This action seeks to ensure the protection of public health and consumer safety, as well as to promote the use of safe ingredients in beauty and personal care products.


The following substances will be banned 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.

For more information on Omnibus VI Act, please click here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0692



Comments


Belab Services

Hire Cosmetic Safety Assessment Experts

With over 10 years of experience in cosmetic safety assessments and regulation, BELAB SERVCES offers a comprehensive and reliable solution to effectively verify and register cosmetic products.

Our solution, based on a deep knowledge of legislation, has a team of scientific consultants and advanced IT tools, making it the fastest and most reliable way to access the European market.


Don't wait any longer and ask us for more information.

bottom of page