EU Cosmetic Regulations

Omnibus VI Regulation

The European Commission notified to the World Trade Organization (WTO) the cosmetic regulation project so-called “Omnibus VI” on November 17th, 2022. The draft is open for comments until the 16th of January 2023. We don’t expect any modification of the regulatory text at this stage.
This OMNIBUS VI regulation incorporate substances classified CMR by the regulation EEC 2022/692 aka ATP 18th of the CLP Regulation (see IL-105 for more details) into the European Cosmetic Regulation 1223/2009. 30 new entries will be added to annex II (prohibited ingredients) and the entry 1024 will be slightly modified to include “salts of 2-ethylhexanoic acid, unless authorized by annex VI”.
The cosmetic industry will mostly be impacted by the prohibition of Margoza Extract, Theophylline, Pentasodium Pentetate, Pentetic Acid, Trimethylolpropane Triacrylate and Benzophenone and cumene (both mainly used as or present in fragrance ingredients). All the substances impacted are listed below.
An adoption of this OMNIBUS VI is expected in the coming months.
The application date of the OMINBUS VI will be the same as the ATP 18th: December 1st 2023. As for every OMNIBUS, the application date is the same for product placed on the market AND product already on the market. In other words, product containing forbidden ingredients must be withdrawn from the market on December 1st 2023.


Annex: changes introduced by regulation OMNIBUS VI to annex II of the cosmetic regulation 1223/2009


Modification of the annex II

Chemical Name/INN Cas Number EC Number
2-ethylhexanoic acid and its salts with the exception of those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008 149-57-5/- 205-743-6/-’

Addition to the annex II

Chemical Name/INN Cas Number EC Number
Ammonium bromide 12124-97-9 235-183-8
Dibutyltin bis(2-ethyl hexanoate) 2781-10-4 220-481-2
Dibutyltin di(acetate) 1067-33-0 213-928-8
Tellurium dioxide 7446-07-3 231-193-1
Barium diboron tetraoxide 13701-59-2 237-222-4
2,2-dimethylpropan-1-ol,tribromo derivative; 3-bromo-2,2-bis(bromo methyl)propan-1-ol 36483-57-5 1522-92-5 253-057-0 –
2,4,6-tri-tert-butylphenol 732-26-3 211-989-5
4,4’-sulphonyldiphenol; bisphenol S 80-09-1 201-250-5
Benzophenone 119-61-9 204-337-6
Quinoclamine (ISO); 2-amino-3-chloro-1,4- naphthoquinone 2797-51-5 220-529-2
Perfluoroheptanoic acid; tridecafluoroheptanoic acid 375-85-9 206-798-9
methyl N-(isopropoxy carbonyl)-L-valyl- (3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate 283159-90-0 608-192-3
6-[C12-18-alkyl-(branched, unsaturated)-2,5- dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl) ammonium salts 701-271-4
6-[(C10-C13)-alkyl-(branched, unsaturated)- 2,5-dioxopyrrolidin-1-yl] hexanoic acid 2156592-54-8 701-118-1
6-[C12-18-alkyl-(branched, unsaturated)-2,5- dioxopyrrolidin-1-yl] hexanoic acid 701-162-1
Theophylline; 1,3-di methyl-3,7-dihydro-1H purine-2,6-dione 58-55-9 200-385-7
1,3,5-triazine-2,4,6-triamine; melamine 108-78-1 203-615-4
Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro5-(trifluoromethyl)-2- pyridylmethyl]benzamide 607-285-6 239110-15-7
N-(2-nitrophenyl) phosphoric triamide 874819-71-3 477-690-9
N-(5-chloro-2-isopropyl benzyl)-N cyclopropyl-3-(difluoromethyl)-5-fluoro-1- methyl-1H-pyrazole-4-carboxamide; isoflucypram 1255734-28-1 811-438-4
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- methano naphthalen-5-yl]pyrazole-4- carboxamide [>78% syn isomers 881685-58-1 632-619-2
Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents] 84696-25-3 283-644-7
Cumene 98-82-8 202-704-5
2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3- propanediyl diacrylate; 2,2- bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate 15625-89-5 239-701-3
Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2- diylnitrilo)pentaacetate 7216-95-7 404-290-3
Ncarboxymethyliminobis (ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI) 67-43-6 200-652-8
Pentasodium (carboxylatomethyl) iminobis(ethylenenitrilo)te traacetate; Pentasodium Pentetate (INCI) 140-01-2 205-391-3
Acetamiprid (ISO); (1E)-N-[(6-chloropyridin3-yl)methyl]-N’-cyano-Nmethylethanimidamide; (E)-N1-[(6-chloro-3- pyridyl)methyl]-N2-cyano-N1- methylacetamidine 135410-20-7 160430-64-8 603-921-1 682-791-8
Pendimethalin (ISO); N-(1-ethylpropyl)-2,6- dinitro-3,4-xylidene 40487-42-1 254-938-2
Bentazone (ISO); 3-isopropyl-2,1,3- benzothia diazine-4-one-2,2-dioxide 25057-89-0 246-585-8’


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  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

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