• November 18, 2022
  • WTO

European Union | Draft Commission Regulation amending Annex II of Regulation (EC) No 1223/2009 on cosmetics



Title of document
Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction

Description
The draft measure is required to enact the prohibition to use, as cosmetic ingredients, substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) by Commission Regulation (EU) No 2022/692, which has been adopted based on the CLP Regulation and will apply from 1 December 2023. The amendment of the Cosmetics Regulation is, therefore, needed to transpose the new CMRs classification provided by Commission Regulation (EU) No 2022/692. 

Notifying member: European Union

NotificationG/TBT/N/EU/935

Objective tag
Protection of human health or safety (TBT)

Documents


Timing:

  • Submission: N/A
  • Reception: N/A
  • Distribution: 17/11/2022
  • Final date for comments: N/A
  • Proposed date of adoption: N/A

EN EN EUROPEAN COMMISSION Brussels, XXX […](2022) XXX draft ANNEX ANNEX to the Commission Regulation (EU) .../... amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction EN 1 EN ANNEX Annex II is amended as follows: (1) entry 1024 of Annex II is replaced by the following: Reference number Substance identification Chemical name/INN CAS number EC number a b c d ʻ1024 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/-’ (2) the following entries are added: Reference number Substance identification Chemical name/INN CAS number EC number a b c d ʻX [OP: please replace with the next consecutive number] Ammonium bromide 12124-97-9 235-183-8 X [OP: please replace with the next consecutive number] Dibutyltin bis(2-ethylhexanoate) 2781-10-4 220-481-2 X [OP: please replace with the next consecutive number] Dibutyltin di(acetate) 1067-33-0 213-928-8 X [OP: please replace Tellurium dioxide 7446-07-3 231-193-1 EN 2 EN with the next consecutive number] X [OP: please replace with the next consecutive number] Barium diboron tetraoxide 13701-59-2 237-222-4 X [OP: please replace with the next consecutive number] 2,2-dimethylpropan-1-ol,tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol 36483-57-5/ 1522-92-5 253-057-0/- X [OP: please replace with the next consecutive number] 2,4,6-tri-tert-butylphenol 732-26-3 211-989-5 X [OP: please replace with the next consecutive number] 4,4’-sulphonyldiphenol; bisphenol S 80-09-1 201-250-5 X [OP: please replace with the next consecutive number] Benzophenone 119-61-9 204-337-6 X [OP: please replace with the next consecutive Quinoclamine (ISO); 2-amino-3-chloro-1,4- naphthoquinone 2797-51-5 220-529-2 EN 3 EN number] X [OP: please replace with the next consecutive number] Perfluoroheptanoic acid; tridecafluoroheptanoic acid 375-85-9 206-798-9 X [OP: please replace with the next consecutive number] methyl N-(isopropoxycarbonyl)-L-valyl- (3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate 283159-90-0 608-192-3 X [OP: please replace with the next consecutive number] 6-[C12-18-alkyl-(branched, unsaturated)-2,5- dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts - 701-271-4 X [OP: please replace with the next consecutive number] 6-[(C10-C13)-alkyl-(branched, unsaturated)- 2,5-dioxopyrrolidin-1-yl]hexanoic acid 2156592-54-8 701-118-1 X [OP: please replace with the next consecutive number] 6-[C12-18-alkyl-(branched, unsaturated)-2,5- dioxopyrrolidin-1-yl]hexanoic acid - 701-162-1 X [OP: please replace with the next consecutive number] Theophylline; 1,3-dimethyl-3,7-dihydro-1Hpurine-2,6-dione 58-55-9 200-385-7 X [OP: 1,3,5-triazine-2,4,6-triamine; melamine 108-78-1 203-615-4 EN 4 EN please replace with the next consecutive number] X [OP: please replace with the next consecutive number] Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro5-(trifluoromethyl)-2- pyridylmethyl]benzamide 607-285-6 239110-15-7 X [OP: please replace with the next consecutive number] N-(2-nitrophenyl)phosphoric triamide 874819-71-3 477-690-9 X [OP: please replace with the next consecutive number] N-(5-chloro-2-isopropylbenzyl)-Ncyclopropyl-3-(difluoromethyl)-5-fluoro-1- methyl-1H-pyrazole-4-carboxamide; isoflucypram 1255734-28-1 811-438-4 X [OP: please replace with the next consecutive number] 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 881685-58-1 632-619-2 X [OP: please replace with the next consecutive number] Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents] 84696-25-3 283-644-7 X [OP: please Cumene 98-82-8 202-704-5 EN 5 EN replace with the next consecutive number] X [OP: please replace with the next consecutive number] 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 [OP: please replace with the next consecutive number] Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2- diylnitrilo)pentaacetate 7216-95-7 404-290-3 X [OP: please replace with the next consecutive number] Ncarboxymethyliminobis(ethylenenitrilo)tetra(a cetic acid); Pentetic Acid (INCI) 67-43-6 200-652-8 X [OP: please replace with the next consecutive number] Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)te traacetate; Pentasodium Pentetate (INCI) 140-01-2 205-391-3 X [OP: please replace with the next consecutive number] 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 [OP: please replace with the next Pendimethalin (ISO); N-(1-ethylpropyl)-2,6- dinitro-3,4-xylidene 40487-42-1 254-938-2 EN 6 EN consecutive number] X [OP: please replace with the next consecutive number] Bentazone (ISO); 3-isopropyl-2,1,3- benzothiadiazine-4-one-2,2-dioxide 25057-89-0 246-585-8’
                   

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