2024年10月3日，英國(guó)向世界貿(mào)易組織遞交G/TBT/N/GBR/81/Add.1號(hào)通報(bào)，以修訂適用于英格蘭、威爾士和蘇格蘭的第1223/2009號(hào)（EC）法規(guī)（《英國(guó)化妝品法規(guī)》）。該修訂草案是對(duì)2024年4月10日英國(guó)遞交的G/TBT/N/GBR/81號(hào)通報(bào)的補(bǔ)遺。
在此次通報(bào)中，英國(guó)商業(yè)貿(mào)易部表示，產(chǎn)品安全和標(biāo)準(zhǔn)辦公室將禁止另外13種CMR物質(zhì)，包括2-乙基己酸鹽，4-硝基嗎啉等在化妝品中的使用。目前該修訂草案正處于評(píng)議期，評(píng)議提交截止日期為2024年12月1日。
此前，2024年4月10日，英國(guó)所遞交的通報(bào)隨附的法定文書(shū)文本草案中列出了52種化妝品中禁用CMR物質(zhì)，同時(shí)限制曲酸在化妝品中的使用：允許在面部和手部產(chǎn)品中使用最高濃度不超過(guò)1%的曲酸。
化妝品中禁用65種CMR物質(zhì)
英國(guó)化妝品法規(guī)規(guī)定，禁止在化妝品中使用英國(guó)CLP法規(guī)收錄的1A、1B或2類(lèi)CMR物質(zhì)。根據(jù)法規(guī)中第31條第1款(f)項(xiàng)內(nèi)容，通報(bào)中所列的65種CMR物質(zhì)均不符合豁免條件, 因此收錄至化妝品禁用物質(zhì)清單監(jiān)管，新增序號(hào)1680至1744條款，具體如下表所示。
序號(hào) | 化學(xué)名稱(chēng) | CAS號(hào) | EC號(hào) |
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 |
該修訂預(yù)計(jì)于2025年1月31日生效。過(guò)渡性條款表明不符合新規(guī)的化妝品，自2025年4月20日起不得上市，自2025年10月20日起不得進(jìn)行銷(xiāo)售。
新增曲酸限用條款
2023年10月,英國(guó)非食品和非藥用消費(fèi)品化學(xué)安全科學(xué)咨詢(xún)小組（SAG-CS）發(fā)布化妝品中曲酸的最終意見(jiàn)，認(rèn)為在面部和手部產(chǎn)品中使用最高濃度為1%的曲酸是安全的。此要求與歐盟化妝品法規(guī)要求完全一致。
根據(jù)英國(guó)化妝品法規(guī)第31條第1款(b)項(xiàng)的規(guī)定，英國(guó)國(guó)務(wù)卿認(rèn)為有充分的科學(xué)證據(jù)表明，在化妝品中使用曲酸對(duì)人類(lèi)健康存在潛在風(fēng)險(xiǎn)。因此，修訂英國(guó)化妝品法規(guī)第1223/2009號(hào)，新增對(duì)于曲酸的使用規(guī)定，具體如下表所示。
序號(hào) | 化學(xué)名稱(chēng) | 常見(jiàn)成分術(shù)語(yǔ)表名稱(chēng) | CAS號(hào) | EC號(hào) | 產(chǎn)品類(lèi)型主要部分 | 最大允許使用濃度 |
323 | 5-hydroxy-2-(hydro xymethyl)pyran-4-one | 曲酸Kojic acid | 501-30-4 | 207-922-4 | 臉部和手部產(chǎn)品 | 1% |
該修訂條款預(yù)計(jì)于2025年1月31日生效。過(guò)渡性條款表明不符合新規(guī)的化妝品，自2025年6月20日起不得上市，自2025年10月1日起不得進(jìn)行銷(xiāo)售。
由瑞旭集團(tuán)自主研發(fā)的中國(guó)化妝品原料法規(guī)數(shù)據(jù)庫(kù)（妝合規(guī)）查詢(xún)信息顯示：曲酸（Kojic Acid），CAS號(hào)501-30-4，在化妝品中用作抗氧化劑、漂白劑，已納入《中國(guó)已使用化妝品原料目錄》（2021年版），目前未納入《中國(guó)化妝品原料禁用清單》。
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