The UK is proposing the prohibition of 13 Carcinogenic, Mutagenic, or Reprotoxic (CMR) substances in cosmetics, including 2-ethylhexanoic acid and 4-nitrosomorpholine. This came in a draft amendment as an addendum to the notification G/TBT/N/GBR/81 submitted by the UK on April 10, 2024. The draft amendment is currently open for public comment, with a submission deadline of December 1, 2024.
The UK submitted notification G/TBT/N/GBR/81/Add.1 to the World Trade Organization on October 3, 2024, setting out the amendment to Regulation No. 1223/2009 (EC) (UK Cosmetics Regulation) applicable to England, Wales, and Scotland.
The amendment is expected to take effect on January 31, 2025 . Transitional provisions indicate that non-compliant cosmetics cannot be placed on the market from April 20, 2025, and sales must cease by October 20, 2025 .
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; |
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 |
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 |
1% |
The amendment is expected to take effect on January 31, 2025. Transitional provisions indicate that non-compliant cosmetics cannot be placed on the market from June 20, 2025, and sales must cease by October 1, 2025.
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