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2020/11/27

歐盟修訂化妝品法規: 新增多項禁用限用染髮成分

資料來源 EUROPEAN COMMISSION、健康產業服務、SGS化妆品及日化产品服务
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歐盟近期內公佈修訂6項限用染髮成分含量、更新1項染髮成分限用、新增3項禁用成分,此篇文章將公佈內容摘錄出來~

20201113日,歐盟公報 Official Journal of the European Union 公佈 EUNo. 2020/1683 修訂案,對歐盟化妝品法規(EC No. 1223/2009 附錄IIIII進行修訂,新增3項禁用染髮成分和6種限用染髮成分,同時更新2-Methoxymethyl-p-phenylenediamine的限用條款,且修訂案內容將於2020123日起生效。

基於歐盟消費者安全科學委員會(簡稱SCCS)的評估意見,歐盟委員會將1,2,4-Trihydroxybenzene2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid4-Amino-3-hydroxytoluene 新增至歐盟化妝品法規附錄II進行監管且禁止用於化妝品中,詳如下表:

物質鑑別 限制
化學名稱 CAS No. EC No. 產品類別 使用調配最大濃度
1,2,4-Trihydroxybenzene 533-73-3 208-575-1 染髮或睫毛染色產品 禁用
2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid 2835-98-5 220-620-7 染髮或睫毛染色產品 禁用
4-Amino-3-hydroxytoluene 1179707-43-4 411-260-3 染髮或睫毛染色產品 禁用
From 3 September 2021 hair and eyelash dye products containing those substances shall not be placed on the Union market.
From 3 June 2022 hair and eyelash dye products containing those substances shall not be made available on the Union market.
 
 
同樣地,依據SCCS的意見,歐盟委員會授權Dimethylpiperazinium Aminopyrazolopyridine HClMethylimidazoliumpropyl p-phenylenediamine HClHC Orange No.6Acid Orange 7Tetrabromophenol BlueIndigofera Tinctorial 成分作為染髮成分用於染髮類產品,因此新增相應條款至歐盟化妝品法規附錄III化妝品限用物質清單,詳如下表:
物質鑑別 限制 使用/警語
化學名稱 俗稱 CAS No. EC No. 產品類別 使用調配最大濃度 其他
4-(3-aminopyrazolo[1,5-A]pyridin-2-yl)-1,1-
dimethylpiperazin1-ium chloride
hydrochloride
Dimethylpiperazinium Aminopyrazolopyridine HCl 1256553- 33-9 813-255-5 氧化型染髮產品   As from 3 June 2021, after mixing under oxi­ dative conditions the
maximum concentration applied to hair must not exceed 2 %  (calculated as free base)
As from 3 December 2021, to be printed on the label: The mixing ratio.
‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk
of allergy. EN Official Journal of the European Union L 379/38 13.11.2020 
Do not colour your hair if:
— you have a rash on your face or sensitive, irritated and damaged scalp,
— you have ever experienced any reaction after colouring your hair,
— you have experienced a reaction to a temporary “black henna” tattoo in the past.’
1-(3-((4-Aminophenyl)amino)propyl)-3-methyl-1Himidazol-3-iumchloride hydrochloride Methylimidazoliumpropyl p-phenylenediamine HCl 220158-86-1   氧化型染髮產品   As from 3 June 2021, after mixing under oxi­ dative conditions the
maximum concentration applied to hair must not exceed 2 %  (calculated as free base)
As from 3 December 2021, to be printed on the label: The mixing ratio.
‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk
of allergy. EN Official Journal of the European Union L 379/38 13.11.2020 
Do not colour your hair if:
— you have a rash on your face or sensitive, irritated and damaged scalp,
— you have ever experienced any reaction after colouring your hair,
— you have experienced a reaction to a temporary “black henna” tattoo in the past.’
Di-[2-[(E)-2-[4-[bis (2-hydroxyethyl) aminophenyl] vinyl]pyridin-1- ium]-ethyl]disulphide dimethanesulfonate HC Orange No 6 1449653-
83-1
  非氧化型染髮產品 As from 3 June 2021: 0.5 % Methanesulfonates impurities, in particular ethyl methanesulfonate shall not be present.  
Sodium 4-[(2- hydroxy-1- naphthyl)azo]benzene sulfonate  Acid Orange 7 633-96-5 211-199-0 非氧化型染髮產品 As from 3 June 2021: 0.5 %    
Phenol, 4,4'- (4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-ylidene)bis[2,6- dibromo Tetrabromophenol Blue 4430-25-5 224-622-9 (a)氧化型染髮產品
(b)非氧化型染髮產品
As from 3 June 2021: 0.2 % (a) As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,2 % (calculated as free base) a) As from 3 December 2021, to be printed on the label:
The mixing ratio.
‘ Hair colorants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or sensitive, irritated and damaged scalp,
— you have ever experienced any reaction after colouring your hair,
— you have experienced a reaction to a temporary “black henna” tattoo in the past.’
Indigofera tinctoria,
dried and pulverised leaves of
Indigofera tinctoria L
Indigofera tinctoria leaf Indigofera tinctoria leaf powder Indigofera tinctoria leaf extract Indigofera tinctoria extract 84775-63-3 283-892-6 非氧化型染髮產品 As from 3 June 2021: 25 %’    
 
2-Methoxymethyl-p-Phenylenediamine A160 and its sulfate,目前受歐盟化妝品法規附錄III292條款監管。 依據SCCS關於該物質用於睫毛意見 SCCS/1603/18 的安全結論,其物質限用範圍擴大至睫毛染色產品,但僅限專業人士使用,且需標註特定警示語,因此附錄III292條款更新如下:
物質鑑別 限制 使用/警語
化學名稱 俗稱 CAS No. EC No. 產品類別 使用調配最大濃度 其他
1,4-Benzenediamine, 2-(methoxymethyl)
1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate
2-Methoxymethylp-Phenylenediamine
2-Methoxymethylp-Phenylenediamine Sulfate
337906-36-2
337906-37-3
679-526-3
638-749-6
(a.)氧化型染髮產品
(b.)睫毛染色
  a)(b)在氧化條件下混合後,應用於頭髮或睫毛的最大濃度不得超過1.8%(以游離鹼計)
b)限專業人士操作
(a) To be printed on the label:
The mixing ratio.
‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. EN Official Journal of the European Union L 379/36 13.11.2020  Temporary “black henna” tattoos may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or sensitive, irritated and damaged scalp,
— you have ever experienced any reaction after colouring your hair,
— you have experienced a reaction to a temporary “black henna” tattoo in the past.’
(b) To be printed on the label:
The mixing ratio.
‘ This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase the risk of allergy.
Eyelashes shall not be coloured if the consumer:
EN Official Journal of the European Union 13.11.2020 L 379/37 
— has a rash on the face or sensitive, irritated and damaged scalp,
— has experienced any reaction after colouring hair or eyelashes,
— has experienced a reaction to a temporary “black henna” tattoo in the past.
For professional use only.
Rinse eyes immediately if product comes into contact with them.’

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