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

from CIRS by

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.

UK,Cosmetic,Restriction,CMR,Substance,Ban

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

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 by June 20, 2025, and sales must cease by October 1, 2025.

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