The European Commission has notified the draft regulation “OMNIBUS VI” to the World Trade Association (WTO) on November 17th, 2022. This OMNIBUS VI regulation incorporate substances classified CMR by the regulation EEC 2022/692 aka ATP 18th of the CLP Regulation into the European Cosmetic Regulation 1223/2009. The aim of this amendment is to implement the ban of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR).
What changes does Omnibus VI entail?
- Among the prohibited ingredients, 30 new entries will be added to annex II. The main impact on the cosmetic industry will be 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).
- The entry 1024 will be slightly modified to include “salts of 2-ethylhexanoic acid, unless authorized by annex VI”.
(see full list of changes below with main cosmetic ingredients highlighted in yellow)
The application deadline:
As for every OMNIBUS, the application date is the same for product placed on the market AND product already on the market. Non-compliant products (containing forbidden ingredients) must be withdrawn from the market on December 1 st 2023.
For more details, our team of toxicologists, cosmetologists and regulatory affairs specialists are at your service to ensure your company a safe growth by alleviating your regulatory burden and preventing any legal threat. Feel free to contact us at: info@biorius.com
Modification of the annex II
| Reference Number | Chemical Name/INN | Cas Number | EC Number |
| ‘1024 | 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/- | 149-57-5/- |
Addition to the annex II
| Reference Number | Chemical Name/INN | Cas Number | EC Number |
| ‘X | Ammonium bromide | 12124-97-9 | 235-183-8 |
| ‘X | Dibutyltin bis(2-ethyl hexanoate) | 2781-10-4 | 220-481-2 |
| ‘X | Dibutyltin di(acetate) | 1067-33-0 | 213-928-8 |
| ‘X | Tellurium dioxide | 7446-07-3 | 231-193-1 |
| ‘X | Barium diboron tetraoxide | 13701-59-2 | 237-222-4 |
| ‘X | 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 |
| ‘X | 2,4,6-tri-tert-butylphenol | 732-26-3 | 211-989-5 |
| ‘X | 4,4’-sulphonyldiphenol; bisphenol S | 80-09-1 | 201-250-5 |
| ‘X | Benzophenone | 119-61-9 | 204-337-6 |
| ‘X | Quinoclamine (ISO); 2-amino-3-chloro-1,4- naphthoquinone | 2797-51-5 | 220-529-2 |
| X | Perfluoroheptanoic acid; tridecafluoroheptanoic acid | 375-85-9 | 206-798-9 |
| ‘X | methyl N-(isopropoxy carbonyl)-L-valyl- (3RS)-3-(4- chlorophenyl)-β-alaninate; valifenalate | 283159-90-0 | 608-192-3 |
| ‘X | 6-[C12-18-alkyl-(branched, unsaturated)-2,5- dioxopyrrolidin-1- yl]hexanoic acid, sodium and tris(2-hydroxyethyl) ammonium salts | – | 701-271-4 |
| ‘X | 6-[(C10-C13)-alkyl- (branched, unsaturated)- 2,5-dioxopyrrolidin-1-yl] hexanoic acid | 2156592-54-8 | 701-118-1 |
| ‘X | 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin 1-yl] hexanoic acid | – | 701-162-1 |
| ‘X | Theophylline; 1,3 -di methyl -3,7 -dihydro 1H purine -2,6-dione | 58-55-9 | 200-385-7 |
| ‘X | 1,3,5-triazine-2,4,6- triamine; melamine | 108-78-1 | 203-615-4 |
| ‘X | Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro5 (trifluoromethyl)-2- pyridylmethyl]benzamide | 607-285-6 | 239110-15-7 |
| ‘X | N-(2-nitrophenyl) phosphoric triamide | 874819-71-3 | 477-690-9 |
| ‘X | 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 |
| ‘X | 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 |
| ‘X | Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents] | 84696-25-3 | 283-644-7 |
| ‘X | Cumene | 98-82-8 | 202-704-5 |
| ‘X | 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 |
| ‘X | Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2- diylnitrilo)pentaacetate | 7216-95-7 | 404-290-3 |
| ‘X | Ncarboxymethyliminobis (ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI) | 67-43-6 | 200-652-8 |
| ‘X | Pentasodium (carboxylatomethyl) iminobis(ethylenenitrilo)te traacetate; Pentasodium Pentetate (INCI) | 140-01-2 | 205-391-3 |
| ‘X | 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 |
| ‘X | Pendimethalin (ISO); N-(1- ethylpropyl)-2,6- dinitro- 3,4-xylidene | 40487-42-1 | 254-938-2 |
| ‘X | Bentazone (ISO); 3- isopropyl-2,1,3-benzothia diazine-4-one-2,2-dioxide | 25057-89-0 | 246-585-8’ |
