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