英国拟在化妆品中禁用65种CMR物质并新增曲酸限用条款
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2024年10月3日,英国向世界贸易组织递交G/TBT/N/GBR/81/Add.1号通报,以修订适用于英格兰、威尔士和苏格兰的第1223/2009号(EC)法规(《英国化妆品法规》)。该修订草案是对2024年4月10日英国递交的G/TBT/N/GBR/81号通报的补遗。

在此次通报中,英国商业贸易部表示,产品安全和标准办公室将禁止另外13种CMR物质,包括2-乙基己酸盐,4-硝基吗啉等在化妆品中的使用。目前该修订草案正处于评议期,评议提交截止日期为2024年12月1日。

此前,2024年4月10日,英国所递交的通报随附的法定文书文本草案中列出了52种化妆品中禁用CMR物质,同时限制曲酸在化妆品中的使用:允许在面部和手部产品中使用最高浓度不超过1%的曲酸。

化妆品中禁用65种CMR物质

英国化妆品法规规定,禁止在化妆品中使用英国CLP法规收录的1A、1B或2类CMR物质。根据法规中第31条第1款(f)项内容,通报中所列的65种CMR物质均不符合豁免条件, 因此收录至化妆品禁用物质清单监管,新增序号1680至1744条款,具体如下表所示。

序号

化学名称

CAS号

EC号

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

 

该修订预计于2025年1月31日生效。过渡性条款表明不符合新规的化妆品,自2025年4月20日起不得上市,自2025年10月20日起不得进行销售。

新增曲酸限用条款

2023年10月,英国非食品和非药用消费品化学安全科学咨询小组(SAG-CS)发布化妆品中曲酸的最终意见,认为在面部和手部产品中使用最高浓度为1%的曲酸是安全的。此要求与欧盟化妆品法规要求完全一致。

根据英国化妆品法规第31条第1款(b)项的规定,英国国务卿认为有充分的科学证据表明,在化妆品中使用曲酸对人类健康存在潜在风险。因此,修订英国化妆品法规第1223/2009号,新增对于曲酸的使用规定,具体如下表所示。

序号

化学名称

常见成分术语表名称

CAS号

EC号

产品类型主要部分

最大允许使用浓度

323

5-hydroxy-2-(hydro

xymethyl)pyran-4-one

曲酸Kojic acid

501-30-4

207-922-4

脸部和手部产品

1%

该修订条款预计于2025年1月31日生效。过渡性条款表明不符合新规的化妆品,自2025年6月20日起不得上市,自2025年10月1日起不得进行销售。

由瑞旭集团自主研发的中国化妆品原料法规数据库(妆合规)查询信息显示:曲酸(Kojic Acid),CAS号501-30-4,在化妆品中用作抗氧化剂、漂白剂,已纳入《中国已使用化妆品原料目录》(2021年版),目前未纳入《中国化妆品原料禁用清单》。

英国,化妆品,CMR物质,曲酸