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 In other words, product containing forbidden ingredients must be withdrawn from the market on December 1st 2023.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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