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; |
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》。
