UK Proposes Ban on 65 CMR Substances in Cosmetics and Introduces New Restrictions on Kojic Acid

On October 3, 2024, the UK submitted notification G/TBT/N/GBR/81/Add.1 to the World Trade Organization to amend Regulation No. 1223/2009 (EC) (UK Cosmetics Regulation) applicable to England, Wales, and Scotland. This draft amendment is an addendum to the notification G/TBT/N/GBR/81 submitted by the UK on April 10, 2024.

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In this notification, the UK Department for Business and Trade indicated that the Office for Product Safety and Standards (OPSS) will prohibit using an additional 13 CMR substances in cosmetics, including 2-ethylhexanoic acid and 4-nitrosomorpholine. The draft amendment is currently open for public comment, with a submission deadline of December 1, 2024.

On April 10, 2024, the UK submitted a notification with a draft statutory instrument listing 52 CMR substances banned in cosmetics. The notification also restricted the use of kojic acid, allowing its use in facial and hand products at a maximum concentration of 1%.

65 CMR Substances Prohibited in Cosmetics

The UK Cosmetics Regulation prohibits the use of category 1A, 1B, or 2 CMR substances listed in the UK CLP Regulation in cosmetics. According to Article 31(1)(f) of the regulation, the 65 CMR substances listed in the notification do not meet the exemption criteria. They are, therefore, included in the list of prohibited substances in cosmetics. They are added as entries 1680 to 1744, as detailed in the table below.

Serial Number	Chemical Substance Name	CAS Number	EC Number
1680	Tetrafluoroethylene	116-14-3	204-126-9
1681	6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC]	119-47-1	204-327-1
1682	(5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone	688046-61-9	692-456-8
1683	(RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate	1101132-67-5
1684	3-methylpyrazole	1453-58-3	215-925-7
1685	N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; Pydiflumetofen	1228284-64-7
1686	N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1Hpyrazole-4-carboxamide; Sedaxane	874967-67-6
1687	Thiophanate-methyl (ISO); dimethyl (1,2-phenylenedicarbamothioyl)biscarbamat; dimethyl 4,4’-(o-phenylene)bis(3- thioallophanate)	23564-05-8	245-740-7
1688	Mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt	8018-01-7
1689	Trinickel disulfide; nickel subsulfide; [1] heazlewoodite [2]	12035-72-2 [1] 12035-71-1 [2]	234-829-6 [1] – [2]
1690	7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide	106-87-6	203-437-7
1691	4-methylpentan-2-one; isobutyl methyl ketone (MIBK)	108-10-1	203-550-1
1692	Carbendazim (ISO); methylbenzimidazole-2-ylcarbamat	10605-21-7	234-232-0
1693	Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4- dimethoxyphenyl)acryloyl)morpholine	110488-70-5; (1135441-72-3)	404-200-2
1694	1,2,4-triazole	288-88-0	206-022-9
1695	Flumioxazin (ISO); N-(7-fluoro-3,4- dihydro-3-oxo-4-prop-2-ynyl-2H-1,4- benzoxazin-6-yl)cyclohex-1-ene-1,2- dicarboximide	103361-09-7
1696	Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl- 5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid	114311-32-9
1697	Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5- methyl[1,3,5]oxadiazinan-4-ylid	153719-23-4	428-650-4
1698	Triticonazole (ISO); (RS)-(E)-5-(4-chlorobe nzylidene)-2,2-dimethyl-1-(1H1,2,4-triazol-1-ylmethyl)cyclopentanol	138182-18-0
1699	Desmedipham (ISO); ethyl 3-phenylcarbamo yloxyphenylcarbamate	13684-56-5	237-198-5
1700	Tellurium dioxide	7446-07-3	231-193-1
1701	Tellurium	13494-80-9	236-813-4
1702	Fluopicolide (ISO);2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2- pyridylmethyl]benzamide	239110-15-7	607-285-6
1703	Daminozide (ISO); 4-(2,2- dimethylhydrazino)-4-oxobutanoic acid; N-dimethylaminosuccinamic acid	1596-84-5	216-485-9
1704	Benzophenone	119-61-9	204-337-6
1705	Acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3- yl)methyl]-N'-cyano-N-methylethanimidamide; (E)-N 1 -[(6-chloro-3-pyridyl)methyl]-N 2 -cyano-N 1 –methylacetamidine	135410-20-7	603-921-1
1706	Theophylline;1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione	58-55-9	200-385-7
1707	N-(2-nitrophenyl)phosphoric triamide	874819-71-3	477-690-9
1708	Dibutyltin di(acetate)	1067-33-0	213-928-8
1709	Dibutyltin bis(2-ethylhexanoate)	2781-10-4	220-481-2
1710	Cumene	98-82-8	202-704-5
1711	Barium diboron tetraoxide	13701-59-2	237-222-4
1712	2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyldiacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate	15625-89-5	239-701-3
1713	Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone	2797-51-5	220-529-2
1714	Pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene	40487-42-1	254-938-2
1715	Isoflucypram (ISO); N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide	1255734-28-1
1716	Dimoxystrobin (ISO); (2E)-2-{2-[(2,5- dimethylphenoxy)methyl]phenyl}-2- (methoxyimino)-N-methylacetamide; (E)-2- (methoxyimino)-N-methyl-2-[a-(2,5-xylyloxy)-o-tolyl]acetamide	149961-52-4	604-712-8
1717	2-(2-methoxyethoxy)ethanol; diethylene glycolmonomethyl ether	111-77-3	203-906-6
1718	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
1719	2,4,6-tri-tert-butylphenol	732-26-3	211-989-5
1720	Ammonium bromide	12124-97-9	235-183-8
1721	Divanadium pentaoxide; Vanadium pentoxide	1314-62-1	215-239-8
1722	Bentazone (ISO); 3-isopropyl-2,1,3- benzothiadiazine-4-one-2,2-dioxide	25057-89-0	246-585-8
1723	Margosa extract. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]	84696-25-3	283-644-7
1724	Valifenalate (ISO); methyl N-(isopropoxycarbonyl)-L-valyl- (3RS)-3-(4-chlorophenyl)-β-alaninate	283159-90-0
1725	Isopyrazam (ISO); reaction mass of 3-(difluorom ethyl)-1-methyl-N- [(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4- methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluor omethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4- tetrahydro-9-isopropyl-1,4-methanona phthalen-5-yl]pyrazole-4-carboxamide [>78% syn isomers≤15% anti isomers relative content];	881685-58-1
1726	Perfluoroheptanoic acid; tridecafluoroheptanoic acid	375-85-9	206-798-9
1727	4,4’-sulphonyldiphenol; bisphenol S	80-09-1	201-250-5
1728	6-[C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid(tetra-PSCA)	2156592-54-8	701-118-1
1729	6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid(Penta-PSCA)		701-162-1
1730	[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl] hexanoic acid, sodium and tris(2-hydroxyethyl) ammoniumsalts; (penta-PSCA Na-TEA)		701-271-4
1731	1,3,5-triazine-2,4,6-triamine; melamine	108-78-1	203-615-4
1732	Benzyl(diethylamino)diphenylphosphonium4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl) propan-2-yl]phenolate	577705-90-9	479-100-5
1733	Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)	75768-65-9	278-305-5
1734	Reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl) propan -2-yl]phenolate (1:1)
1735	Reaction mass of 4,4'-[2,2,2-trifluoro1-(trifluoromethyl)ethylidene] diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethyli dene]bis[phenol] (1:1)
1736	Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2- ((2,3-epoxypropoxy) methyl) -2-hydroxymethylbutane
1737	4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethyli dene]diphenol; bisphenol AF	1478-61-1	216-036-7
1738	Transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyltrans-2-(2,2-dichlorovinyl)-3,3-dimethylcyclopropanecar boxylate	118712-89-3	405-060-5
1739	Salts of 2-ethylhexanoic acid
1740	Benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine	1861-40-1	217-465-2
1741	N,N-dimethyl-p-toluidine	99-97-8	202-805-4
1742	4-nitrosomorpholine	59-89-2
1743	3,3'-dimethylbiphenyl 4,4'-diyl diisocyanate	91-97-4	202-112-7
1744	Foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N dimethylbenzamide; 1-(4,6-dimetho xypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5 -formamidophenylsulfonyl)urea	173159-57-4

The amendment is expected to take effect on January 31, 2025. Transitional provisions indicate that non-compliant cosmetics cannot be placed on the market by April 20, 2025, and sales must cease by October 20, 2025.

New Restrictions on Kojic Acid

In October 2023, the UK Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) issued a final opinion on kojic acid in cosmetics, stating that its use at a maximum concentration of 1% in facial and hand products is safe. This requirement aligns with the EU Cosmetics Regulation.

According to Article 31(1)(b) of the UK Cosmetics Regulation, the UK Secretary of State has determined that there is sufficient scientific evidence indicating a potential risk to human health from the use of kojic acid in cosmetics. Consequently, the UK Cosmetics Regulation No. 1223/2009 has been amended to include specific provisions for the use of kojic acid, as detailed in the table below.

Serial Number

Chemical Substance Name

Ingredient Glossary Name

CAS Number

EC Number

Main Product Name

Maximum Permitted Use Concentration

323

5-hydroxy-2-(hydro

xymethyl)pyran-4-one

Kojic acid

501-30-4

207-922-4

Facial and Hand Products

The amendment is expected to take effect on January 31, 2025. Transitional provisions indicate that non-compliant cosmetics cannot be placed on the market by June 20, 2025, and sales must cease by October 1, 2025.

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