Omnibus Act VI will apply as of December 1, 2023

December 5, 2022 – On May 3, 2022, the European Commission published the Commission Delegated Regulation (EU) 2022/692, also known as the 18^th Adaptation to Technical Progress (ATP). The law includes the substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). Among them, there are 30 substances that are also used as cosmetic ingredients, which will become prohibited for use in cosmetic products.

Omnibus Act VI

The European Commission drafted the Omnibus Act VI, which prescribes a new ban of 30 cosmetic ingredients. Currently, the document is a draft, as it has not been officially published yet.

The industry has not defended any of the cosmetic ingredients involved. Hence, according to the draft, they will all be added to Annex II to the EU Cosmetics Regulation and, therefore, banned for use in cosmetic products. Omnibus Act VI aims to comply with Article 15 of the EU Cosmetics Regulation, which foresees a general ban on CMR substances in cosmetic products. In fact, CMR substances can only be used in cosmetics by way of exception if they meet the requirements of Article 15(1)(2).

Application

The 18^th ATP and Omnibus Act VI will apply as of the same date. Following the corrigendum to Commission Delegated Regulation (EU) 2022/692 of May 25, 2022, they will apply from December 1, 2023.

In light of this, as of December 1, 2023, cosmetic products containing any of the concerned ingredients can no longer be placed or made available on the EU market.

Which ingredients will be banned?

According to the Omnibus Act VI draft, the following ingredients will be prohibited for use in cosmetics starting from December 1, 2023:

• 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.

 

Moreover, in the entry of 2-ethylhexanoic acid in Annex II, its salt was added.

 

Update from 05/12/2022

The notification to the WTO

On November 17, 2022, the European Commission notified the World Trade Organization (WTO) of the Omnibus Act VI, which will be likely published on the third quarter of 2023. The draft confirms that the restrictions described above will apply. From the date of notification, States have 60 days to submit their comments.  

 

Even though the text is still a draft, we invite all beauty brands to check if their products contain any ingredients listed in Omnibus Act VI and act consequently. Act now to ensure compliance by the deadline, as reformulation and PIF review take time. Contact us today, and we will guide you step by step.

Lastly, we would like to kindly remind you that as of December 17, 2022, Omnibus V will be fully applicable. Check it out here, and be ready!

 

References:

• European Commission. (2022). Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures. Retrieved on 27/06/2022
• European Commission. (2022). Corrigendum to Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures. Retrieved on 27/06/2022
• WTO. (2022). Notification G/TBT/N/EU/935. Retrieved on 05/12/2022