On 20 July 2023, the European Commission published the CMR Omnibus VI Regulation, formally EU Regulation 2023/1490. The regulation aims to prohibit the substances classified as Carcinogenic, Mutagenic and Toxic to Reproduction (CMR) 1A, 1B, or 2 by the 18th Adaptation to Technical Progress (ATP) to the EU Classification Labelling and Packaging (CLP) Regulation.
As of 1 December 2023, cosmetic products containing any of the concerned substances shall no longer be placed or made available on the EU market.
Regulation (EC) 1272/2008 of the European Parliament and of the Council provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific assessment by the Risk Assessment Committee of the European Chemicals Agency (ECHA). The substances are classified as CMR substances of category 1A, 1B or 2 depending on the level of evidence of their CMR properties.
Article 15 of Regulation (EC) 1223/2009 provides that substances which have been classified as CMR substances of category 1A, category 1B or category 2 under Part 3 of Annex VI to Regulation (EC) 1272/2008 (CMR substances) are to be prohibited from use in cosmetic products. A CMR substance may however be used in cosmetic products where the conditions laid down in Article 15, second sentence of Regulation (EC) 1223/2009 or in Article 15, second subparagraph of that Regulation are fulfilled.
In order to implement the prohibition of CMR substances within the European market and to ensure a high level of protection of human health, all CMR substances should be included in the list of prohibited substances in Annex II of Regulation (EC) 1223/2009 and, where relevant, deleted from the lists of restricted or allowed substances in Annexes III to VI to that Regulation. Where the conditions laid down in Article 15, second sentence of Regulation (EC) 1223/2009 or in Article 15, second subparagraph of that Regulation are fulfilled, the lists of restricted or allowed substances in Annexes III to VI to that Regulation should be amended accordingly.
30 new substances shall be included in Annex II of prohibited substances:
- Ammonium Bromide (CAS: 12124-97-9)
- Dibutyltin bis(2-ethylhexanoate) (CAS: 2781-10-4)
- Dibutyltin di(acetate) (CAS: 1067-33-0)
- Tellurium dioxide (CAS: 7446-07-3)
- Barium diboron tetraoxide (CAS: 13701-59-2)
- 2,2-dimethylpropan-1-ol,tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol (CAS: 36483-57-5/1522-92-5)
- 2,4,6-tri-tert-butylphenol (CAS: 732-26-3)
- 4,4’-sulphonyldiphenol; bisphenol S (CAS: 80-09-1)
- Benzophenone (INCI) (CAS: 119-61-9)
- Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone (CAS: 2797-51-5)
- Perfluoroheptanoic acid; tridecafluoroheptanoic acid (CAS: 375-85-9)
- methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate (CAS: 283159-90-0)
- 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts (CAS: -/EC 701-271-4)
- 6-[(C10-C13)-alkyl-(branched, unsaturated)- 2,5-dioxopyrrolidin-1-yl]hexanoic acid (CAS: 2156592-54-8)
- 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (CAS: -/EC 701-162-1)
- Theophylline (INCI); 1,3-dimethyl-3,7-dihydro-1Hpurine-2,6-dione (CAS: 58-55-9)
- 1,3,5-triazine-2,4,6-triamine; melamine (INCI) (CAS: 108-78-1)
- Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro5-(trifluoromethyl)-2-pyridylmethyl]benzamide (CAS: 607-285-6)
- N-(2-nitrophenyl)phosphoric triamide (CAS: 874819-71-3)
- N-(5-chloro-2-isopropylbenzyl)-Ncyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide;isoflucypram (CAS: 1255734-28-1)
- Reaction mass of 3-(difluoromethyl)-1-methylN-[(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 (CAS: 881685-58-1).
- Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents] (CAS: 84696-25-3)
- Cumene (CAS: 98-82-8)
- 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate (INCI)(CAS: 15625-89-5)
- Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate (CAS: 7216-95-7)
- N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI) (CAS: 67-43-6)
- Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate; Pentasodium Pentetate (INCI) (CAS: 140-01-2)
- Acetamiprid (ISO); (1E)-N-[(6-chloropyridin3-yl)methyl]-N’-cyano-Nmethylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine (CAS: 135410-20-7/160430-64-8)
- Pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene (CAS: 40487-42-1)
- Bentazone (ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide (CAS: 25057-89-0)
The substance 2-ethylhexanoic acid (CAS: 149-57-5) is currently listed in Annex II/1024. However, the salts of that substance, which have been classified as CMR substances (category 1B) are not included in that entry. Therefore, those substances should be added to the list of substances prohibited in cosmetic products in Annex II and the salts of the substance 2-ethylhexanoic acid should be added in entry 1024 of that Annex, with the exception of those specified elsewhere in Annex VI to Regulation (EC) 1272/2008.
Among the substances listed above, we highlighted the following cosmetic ingredients:
- Salts of 2-ethylhexanoic acid (Zinc Ethylhexanoate) unless those authorized by Annex VI to Regulation (EC) 1272/2008.
- Benzophenone
- Theophylline
- Melamine
- Azadirachta Indica Seed Extract
- Azadirachta Indica Bark/Seed Extract
- Trimethylolpropane Triacrylate
- Pentetic Acid
- Pentasodium Pentetate
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