The Impact of Omnibus VI Regulation on the European Cosmetic Industry

The recent unveiling of the Omnibus VI Regulation marks a significant milestone in the European cosmetics industry. This regulation imposes a ban on 30 CMR (Carcinogenic, Mutagenic, or Toxic for Reproduction) classified ingredients commonly used in cosmetics. Among the restricted substances are Margoza Extract, Theophylline, Pentasodium Pentetate, Pentetic Acid, Trimethylolpropane Triacrylate, Benzophenone, and Cumene. Notably, Benzophenone and Cumene are frequently found in fragrance ingredients.

Key Provisions:

1. Prohibited Ingredients: The Omnibus VI Regulation specifically targets 30 CMR classified ingredients. Main cosmetic ingredients affected include Margoza Extract, Theophylline, Pentasodium Pentetate, Pentetic Acid, Trimethylolpropane Triacrylate, Benzophenone, and Cumene. These substances are listed in detail in the annex of this information letter, with key cosmetic ingredients highlighted in yellow.

2. Application Date: The regulation is set to take effect on December 1st, 2023. This implies that, post this date, no cosmetic product containing these banned ingredients can be legally available on the market.

Impact on the Cosmetic Industry:

1. Market Adjustments: The prohibition of these ingredients will necessitate a significant adjustment within the cosmetics market. Companies using these substances in their formulations will need to reformulate their products to comply with the new regulatory standards.

2. Supply Chain Implications: Manufacturers and suppliers in the cosmetics supply chain will be directly impacted. Sourcing alternative ingredients that meet regulatory approval will be crucial to maintaining product availability.

3. Compliance Challenges: The regulatory changes pose challenges for companies in terms of compliance. Adhering to the new standards requires a comprehensive understanding of the banned ingredients and a meticulous review of product formulations.

4. Consumer Awareness: As the industry adapts to these changes, consumer awareness becomes paramount. Companies will need to communicate transparently about reformulations, emphasizing safety and compliance with the Omnibus VI Regulation.

• 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.
  
  The Omnibus VI Regulation introduces a transformative shift in the European cosmetics industry, particularly with the prohibition of 30 CMR classified ingredients. As the application date approaches, companies must proactively address the challenges posed by reformulation and compliance to ensure a smooth transition in the market. Transparent communication with consumers will be crucial in maintaining trust and upholding the industry's commitment to safety and regulatory compliance.