European Commission to Ban 31 CMR Substances in Cosmetics - Regulatory News - Personal and Home Care Products

The European Commission is to prohibit the use of 31 carcinogenic, mutagenic or toxic for reproduction (CMR) substances in cosmetic products. The Commission notified WTO of the amendments on November 17, 2022.

The CMRs that are affected include:

ammonium bromide;
benzophenone;
acetamiprid;
2,4,6-tri-tert-butylphenol;
dibutyltin di(acetate); and
2-ethylhexanoic acid and its salts, with the exception of those specified in Annex VI to the cosmetic products Regulation.

These substances were added to Annex II of the Regulation (EC) No 1223/2009 and the ban on their use in cosmetics will apply from December 1, 2023.

Previously on May 23, 2022, these 31 substances were added to Annex VI of the Regulation on the classification, labelling and packaging of substances and mixtures (CLP) during the 18th adaptation to technical progress (ATP)

Annex II is amended as follows:

1. Entry 1024 of Annex II is replaced by the following:

Chemical name/INN	CAS 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/-

2. The following entries are added:

Chemical name/INN	CAS number	The Regulatory list in China
Ammonium bromide	12124-97-9	Inventory of Existing Chemical Substances in China (IECSC)
Dibutyltin bis(2-ethylhexanoate)	2781-10-4	IECSC
Dibutyltin di(acetate)	1067-33-0
Tellurium dioxide	7446-07-3	IECSC
Barium diboron tetraoxide	13701-59-2	IECSC
2,2-dimethylpropan-1-ol,tribromo derivative;3-bromo-2,2-bis(bromomethyl) propan-1-ol	36483-57-5/ 1522-92-5	IECSC
2,4,6-tri-tert-butylphenol	732-26-3	IECSC
4,4’-sulphonyldiphenol; bisphenol S	80-09-1	IECSC
Benzophenone	119-61-9	Inventory of Existing Cosmetic Ingredients in China (IECIC 2021)
Quinoclamine(ISO); 2-amino-3-chloro-1,4-naphthoquinone	2797-51-5
Perfluoroheptanoic acid; tridecafluoroheptanoic acid	375-85-9
Methyl N-(isopropoxycarbonyl)-L-valyl- (3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate	283159-90-0
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	2156592-54-8
6-[C12-18-alkyl-(branched,unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid	/
Theophylline;1,3-dimethyl-3,7-dihydro-1Hpurine-2,6-dione	58-55-9	IECIC 2021
1,3,5-triazine-2,4,6-triamine; melamine	108-78-1	IECSC
Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro5-(trifluoromethyl)-2- pyridylmethyl]benzamide	239110-15-7
N-(2-nitrophenyl)phosphoric triamide	874819-71-3
N-(5-chloro-2-isopropylbenzyl)-Ncyclopropyl-3-(difluoromethyl)-5-fluoro-1- methyl-1H-pyrazole-4-carboxamide; isoflucypram	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	881685-58-1
Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]	84696-25-3	IECIC 2021
Cumene	98-82-8	IECSC
2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3- propanediyl diacrylate; 2,2- bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate;	15625-89-5	IECIC 2021
Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate	7216-95-7	IECSC
Ncarboxymethyliminobis(ethylenenitrilo)tetra(a cetic acid); Pentetic Acid (INCI)	67-43-6	IECIC 2021
Pentasodium(carboxylatomethyl)iminobis(ethylenenitrilo)te traacetate; Pentasodium Pentetate (INCI)	140-01-2	IECIC 2021
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	IECSC
Pendimethalin(ISO);N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene	40487-42-1	IECSC
Bentazone (ISO); 3-isopropyl-2,1,3- benzothiadiazine-4-one-2,2-dioxide	25057-89-0	IECSC

Substances including Benzophenone, Theophylline, Melia Azadirachta Seed Extract, Trimethylolpropane Triacrylate, Pentetic Acid, Pentasodium Pentetate are also listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021), if you would like to know more info about these substances or whether your substances are listed in the IECIC, please search our free cosmetic inventory search system – China CosIng 20.

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Further Information

https://members.wto.org/crnattachments/2022/TBT/EEC/22_7878_00_e.pdf

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