火狐体育

中國化妝品原料目錄全面更新

在中國化妝品法規體系下,中國主管當局基于以下化妝品原料目錄清單對化妝品及化妝品原料的安全性進行監管。

《已使用化妝品原料名稱目錄(2015版)》(簡稱IECIC 2015)

用途:用于判斷是否屬于化妝品新原料

《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表1 化妝品禁用組分

用途:該目錄中的原料不得有意添加用于化妝品的生產與銷售

《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表2 化妝品禁用植(動)物組分

用途:該目錄中的動植物原料不得有意添加用于化妝品的生產與銷售

《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表3 化妝品限用組分

用途:使用該目錄中的原料需滿足相應的限用要求如使用范圍、用于化妝品中的最大允許濃度、雜質、使用人群及標簽等要求

《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表4 化妝品準用防腐劑

用途:允許使用該目錄中的防腐劑用于化妝品且需滿足相應的限用要求

《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表5 化妝品準用防曬劑

用途:允許使用該目錄中的防曬劑用于化妝品且需滿足相應的限用要求

《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表6 化妝品準用著色劑

用途:允許使用該目錄中的著色劑用于化妝品且需滿足相應的限用要求

 《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表7 化妝品準用染發劑

用途:允許使用該目錄中的染發劑用于化妝品且需滿足相應的限用要求

國際化妝品原料標準中文名稱目錄(2010年版)

yongtu:yongyucankaohuazhuangpinyuanliaodebiaozhunzhongwenmingcheng

       為了進一步規范化妝品原料管理及加強其安全監管,國家藥品監督管理局組織對《已使用化妝品原料名稱目錄》、《化妝品禁用組分》和《化妝品禁用植(動)物組分》進行修訂形成了《已使用化妝品原料目錄(2021年版)》、《化妝品禁用原料目錄》和《化妝品禁用植(動)物原料目錄》。因此,在中國化妝品法規體系下,主管當局將基于以下化妝品原料目錄清單對化妝品及化妝品原料進行監管。

  • 《已使用化妝品原料目錄》(2021版)(簡稱IECIC 2021)
  • 《化妝品安全技術規范》(2015版)(簡稱STSC 2015)表1 化妝品禁用原料目錄
  • 《化妝品安全技術規范》(2015版)(簡稱STSC 2015)表2化妝品禁用植(動)物原料目錄
  • 《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表3 化妝品限用組分
  • 《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表4 化妝品準用防腐劑
  • 《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表5 化妝品準用防曬劑
  • 《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表6 化妝品準用著色劑
  • 《化妝品安全技術規范(2015版)》(簡稱STSC 2015)表7 化妝品準用染發劑
  • 國際化妝品原料標準中文名稱目錄(2010年版)
  • 國際化妝品原料標準中文名目錄(2018;征求意見稿)

背 景

《已使用化妝品原料目錄(征求意見稿)》

        2014 nian,yuanguojiashipinyaopinjianduguanlizongjuzaiduiyishangshihuazhuangpinzhongcengshiyonghuazhuangpinyuanliaojinxingzhenglihekeguanshouludejichushang,xingchengle《yishiyonghuazhuangpinyuanliaomingchengmulu》,bingyu 2015 nianjinxinglexiuding。《yishiyonghuazhuangpinyuanliaomingchengmulu(2015ban)》(iecic 2015)gongshoulule8783zhongyishiyongyuanliao。huazhuangpinyuanliaoanquanyuhuazhuangpinchanpinanquanjinmixiangguan,wanzhengdeyuanliaoshujukushihuazhuangpinfengxianpinggudejichu。eriecic 2015jinzaimingyishiyongyuanliaodemingcheng,bingweiduiyuanliaodeshiyongxinxidengjinxingzhengli,wufaweifengxianpinggutigongcankao。gaimuluhuancunzaiyu《huazhuangpinanquanjishuguifan》(2015 ban)zaimingdehuazhuangpinjinxianyongzufenhezhunyongzufenzhijianguanxibuqingxidewenti,bufenyuanliaoxinxixuyaowanshan。

        2021nian1yue26ri,zhongguoshipinyaopinjiandingyanjiuyuanzuzhidui《yishiyonghuazhuangpinyuanliaomingchengmulu》jinxinglexiuding,xingcheng

《yishiyonghuazhuangpinyuanliaomulu(zhengqiuyijiangao)》、《<yishiyonghuazhuangpinyuanliaomulu>diaozhengneirongduizhaobiao》he《<yishiyonghuazhuangpinyuanliaomulu>zhixiudingshuoming》,bingduiwaigongkaizhengqiuyijian,yijianzhengjijiezhishijianwei2021nian2yue18ri。

        xiangjiaoiecic 2015de8783zhongyuanliao, 《yishiyonghuazhuangpinyuanliaomulu(zhengqiuyijiangao)》shoulule8980zhongyuanliao。zhuyaozaiyixiajifangmianjinxinglediaozheng:

1)         增加原料最高歷史使用量信息

xuanqu2010 nianzhi 2020 nian 3 yuehuazhuangpinxingzhengxukeguanlixitongzhongyihuopizhundeteshuyongtuhuazhuangpinhejinkouputonghuazhuangpin,duichanpinpeifangsuoyoushiyongguodeyuanliaofenbieanzhaolinxileihezhuliuleimingquebutongyuanliaodezuigaolishishiyongliang,zengbuzai《yishiyonghuazhuangpinyuanliaomulu(zhengqiuyijiangao)》zhong。

beizhu:zuigaolishishiyongliangxinxishiyihuazhuangpinxingzhengxukeguanlixitongzhongyipizhunhuazhuangpinshenbaoxinxiweijichu,ruguozhiyouzhuliuleichanpinzuigaolishishiyongliangxinxi,linxileichanpinkecanzhaozhuliuleichanpinxinxishiyong。

2)增補審評審核通過的化妝品原料(7

tuofengyou、chiguo(elaeagnus mollis diel)you、guanggancaoding、yueguixianjingansuan hcl、jiayangji peg-23 jiajibingxisuan zhi/ganyoueryiyingzhisuanzhijiajibingxisuanzhigongjuwu、linxianjiguatanggaiheyingzhichunjumi-200

3)對《化妝品安全技術規范》中未收載于IECIC 2015的限用組分、防腐劑、防曬劑、著色劑、染發劑視為已使用原料,增補至《已使用化妝品原料目錄(征求意見稿)》中

4)根據化妝品行政許可管理系統中原料的具體使用情況,將IECIC 2015中的類別原料已使用的具體原料名稱添加至《已使用化妝品原料目錄(征求意見稿)》中(63

fushengshengwutiquwu:3

hezao:4

zaotiquwu:27

lankezhiwu(orchid)tiquwu:9

zhiwuyou:9

qinghuazhiwuyou:11

5)根據《國際化妝品原料字典與手冊》、《中國藥典》、《中國植物志》等,對IECIC 2015中存在一個原料序號對應兩個名稱的,保留其中一個規范名稱(19

6)規范部分原料命名(中/英文/INCI 名稱)(437

7)刪除了一些完全相同的原料名稱(4

bingxisuan(zhi)lei/shanyuchunbingxisuanzhi/juerjiajiguiyangwanjiajibingxisuanzhigongjuwu、laimeng(citrus aurantifolia)guotiquwu、lizhi(litchichinensis)zitiquwu、meigui(rosa rugosa)huatiquwu

8)經比對化妝品行政許可管理系統中產品信息,刪除了一些無使用歷史且來源不清的原料(3

heimayi、longnaoxiang、shemazi

《已使用化妝品原料目錄(2021版)》(簡稱IECIC 2021)

2021年4月30日國家藥品監督管理局發布了《已使用化妝品原料目錄(2021年版)》,自2021年5月1日起施行。相較《已使用化妝品原料目錄(征求意見稿)》的8980種原料,《已使用化妝品原料目錄(2021年版)》收錄了8972種原料,主要變化如下:

刪除了16種重復成分:

yueguixianjingansuanyizhihcl

ethyl lauroyl arginate hcl

8-qianjikuilinliusuanyan

oxyquinoline sulfat

erliuhuaxi

selenium disu

eranjimidingyanghuawu

diaminopyrimidine oxid

linsanhuajing-5-chun

o-cymen-5-ol

juanbingjishuanggua

polyaminopropyl biguanid

1,3-shuang-(2,4-eranjibenyangji)bingwanyansuanyan

1,3-bis-(2,4-diaminophenoxy)propane hcl

2,4-eranjibenyangjiyichunyansuanyan

2,4-diaminophenoxyethanol hcl

2,6-erjiayangji-3,5-bidingeranyansuanyan

2,6-dimethoxy-3,5-pyridinediamine hcl

6-jiayangji-2-jiaanji-3- anjibidingyansuanyan (hclan7hao)

6-methoxy-2-methylamino-3-aminopyridine hcl

qianyiji-3,4-yajiaeryangjibenanyansuanyan

hydroxyethyl-3,4-methylenedioxyaniline hcl

qianbingjishuang(n-qianyijiduibeneran)yansuanyan

hydroxypropyl bis(n-hydroxyethyl-p-phenylenediamine) hcl

jiananjibenfenyansuanyan

m-aminophenol hcl

duianjibenfenyansuanyan

p-aminophenol hcl

duijiajianjibenfen

p-methylaminophenol

duibeneranyansuanyan

p-phenylenediamine hcl

新增了8種成分:

rongzaohujun(vibrio alginolyticus )

tiquwu

vibrio alginolyticus extract

changerchizhuangzao(odontella aurita)

tiquwu

odontella aurita extract

changerchizhuangzao(odontella aurita)

you

odontella aurita oil

gexianmi(nostoc sphaeroides)

tiquwu

nostoc sphaeroides extract

balvqianlvgaoglypeiweihuahewu

aluminum zirconium octachlorohydrex 

gly

xialvfen

chlorophene

xijingshihu(dendrobium candidum)

jingtiquwu

dendrobium candidum stem extract

xijingshihu(dendrobium candidum)

tiquwu

dendrobium candidum extract

《化妝品禁用原料目錄(征求意見稿)》和《化妝品禁用植(動)物原料目錄(征求意見稿)》

       suizhuhuazhuangpinxingyedefazhanhekexuerenshidetigao,genjuwoguoduiyixiehuazhuangpinyuanliaofengxianpinggujieguo,tongshicankaojinjinianoumeng、meiguodenghuazhuangpinxingyefadaguojiahuodiquduiyixiehuazhuangpinpingguhefaguidiaozhengqingkuang,faxianbufenyuanliaojixudiaozhengguanlishiyongyaoqiu。

       2021nian1yue22riguojiayaopinjianduguanlijuzuzhizhongguoshipinyaopinjiandingyanjiuyuanduihuazhuangpinjinyongyuanliaomuludengwenjianjinxinglexiuding,xingchengle《biao1 huazhuangpinjinyongyuanliaomulu(zhengqiuyijiangao)》、《biao2 huazhuangpinjinyongzhi(dong)wuyuanliaomulu(zhengqiuyijiangao)》、《biao3 <huazhuangpinjinyongyuanliaomulu>xiudingqianhouduizhaobiao》、《biao4 <huazhuangpinjinyongzhi(dong)wuyuanliaomulu>xiudingqianhouduizhaobiao》he《<huazhuangpinjinyongyuanliaomulu>zhixiudingshuoming》bingxiangshehuigongkaizhengjiyijian,yijianzhengjijiezhishijianwei2021nian2yue18ri。

       《huazhuangpinanquanjishuguifan(2015nianban)》yuanyoude《huazhuangpinjinyongzufen(biao1)》he《huazhuangpinjinyongzhi(dong)wuzufen(biao2)》fenbieyou1290zhongjinyongzufenhe98zhongjinyongzhi(dong)wuzufen,《biao1 huazhuangpinjinyongyuanliaomulu(zhengqiuyijiangao)》、《biao2 huazhuangpinjinyongzhi(dong)wuyuanliaomulu(zhengqiuyijiangao)》fenbiehanyou1309zhongjinyongyuanliaohe112zhongjinyongzhi(dong)wuyuanliao。xiangjiaozhixia,zhuyaoyouyixiadiaozheng:

新增17種化妝品禁用原料

2,6-erqianji-4-jiajibenjiaquan (taiheiquan)

2,6-dihydroxy-4-methyl-benzaldehyde (atranol) ( cas no. 526-37-4)

2-lvduibeneran,2-lvduibeneranliusuanyan

2-chlorobenzene-1,4-diamine (2-chloro-p-phenylenediamine) (cas no. 615-66-7) and its sulfate (cas no. 61702-44-1)

xinlinglanquan(3-he4-(4-qianji-4-jiajiwuji)-3-huanjixi-1-jiaquan)

3-and4-(4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (hicc) (cas no. 51414-25-6) (cas no. 31906-04-4))

3-yaxiajizhangnao

3-benzylidene camphor (cas no. 15087-24-8)

3-lv-2,6-erqianji-4-jiaji-benjiaquan (lvhuataiheiquan)

3-chloro-2,6-dihydroxy-4-methyl-benzaldehyde (chloroatranol)(cas no. 57074-21-2)

pengsuan、pengsuanyanhesipengsuanyan

boric acid (cas no. 10043-35-3), borates and tetraborates

xialvfen

clorofene; chlorophene; 2-benzyl-4-chlorophenol (cas no. 120-32-1)

huanjian

cyclohexylamine (cas no. 108-91-8)

erlvjiawan

dichloromethane; methylene chloride (cas no. 75-09-2)

jiaquan

formaldehyde (cas no. 50-00-0)

mizuo

imidazole (cas no. 288-32-4)

xiaojijiawan

nitromethane (cas no. 75-52-5)

duojujiaquan

paraformaldehyde (cas no. 30525-89-4)

feineixiding

phenacetin (cas no. 62-44-2)

guopengsuanna

sodium perborate (cas no. 7632-04-4)

yisuanyixizhi

vinyl acetate (cas no. 108-05-4)

wanshoujuhua(tagetes erecta)tiquwu, wanshoujuhua(tagetes erecta)you

tagetes erecta l.(tagetes erecta flower extract; tagetes erecta flower oil)

修訂13種化妝品禁用原料

guifanbufenyuanliaomingcheng、buchongbufenyuanliaocashao/echaodeng

分類合并3類禁用藥物成分

kangganranleiyaowu,baokuodanbuxianyusanxiushalun、kangshengsulei、erqingsuzaichun、yiliuyiyanan、funanzuotong、tongkangzuo、jiaxiaozuo、funantuoyin、huanganleiyaowu(huanganheqianjideyigehuoduogeqingyuanzibeiqudaideyanshengwu)jiqiyanlei、jiaqiumizuodeng

anti-infectives, including but not limited to 3,4',5-tribromosalicylanilide (tribromsalan (inn) )(cas no. 87-10-5), antibiotics, dihydrotachysterol (inn) (cas no. 67-96-9), ethionamide (inn) (cas no. 536-33-4), furazolidone (inn) (cas no. 67-45-8), ketoconazole (cas no. 65277-42-1), metronidazole (cas no. 443-48-1), nitrofurantoin (inn) (cas no. 67-20-9), sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more h-atoms of the -nh2 groups) and their salts, thiamazole (inn) (cas no. 60-56-0)

kangzuanyao,baokuodanbuxianyuxiubenneiminjiqiyanlei、lvbenshaming、benhailamingjiqiyanlei、duoxilaminjiqiyanlei、qianqin、qubineimin、ximitidingdeng

antihistamines, including but not limited to brompheniramine (inn) (cas no. 86-22-6)and its salts, chlorphenoxamine (inn) (cas no. 77-38-3), diphenhydramine (inn) (cas no. 58-73-1) and its salts, doxylamine (inn) (cas no. 469-21-6) and its salts, hydroxyzine (inn) (cas no. 68-88-2), tripelennamine (inn) (cas no. 91-81-6), cimetidine(inn)(cas no. 51481-61-9)

jisulei,baokuodanbuxianyuzaizujiegoudekangxiongjisuwuzhi、shenshangxiansu、tangpizhijisulei(pizhileiguchun)、cijisulei、yunjisulei、juyouxiongjisuxiaoyingdewuzhideng

hormones, including but not limited to anti-androgens of steroidal structure, epinephrine (inn) (cas no. 51-43-4), glucocorticoids (corticosteroids), oestrogens, progestogens, substances with androgenic effect

修訂27種禁用植(動)物原料

guifanyuanliaomingcheng、mingminggeshiyuzhengming/yiming

關于大麻二酚等多種大麻類物質列為化妝品禁用組分的征求意見

       2021nian3yue26rizhongguoshipinyaopinjiandingyanjiuyuanfabuguanyujiuxiudinghuazhuangpinjinyongzufengongkaizhengqiuyijiandetongzhi。genjuguojiajinduguanlixiangguanzhengceyaoqiu,nijiangdama(cannabis sativa)renguo、dama(cannabis sativa)ziyou、dama(cannabis sativa)xietiquwuhedamaerfendengyuanliaolieweihuazhuangpinjinyongzufen,bingxiangshehuigongkaizhengqiuyijian。yijianzhengjijiezhishijianwei2021nian4yue19ri。

《化妝品禁用原料目錄》和《化妝品禁用植(動)物原料目錄》

        2021nian5yue26riguojiayaopinjianduguanlijufabuleguanyugengxinhuazhuangpinjinyongyuanliaomuludegonggao。dui《huazhuangpinanquanjishuguifan(2015nianban)》dierzhangzhongde《huazhuangpinjinyongzufen(biao1)》he《huazhuangpinjinyongzhi(dong)wuzufen(biao2)》jinxinglexiuding,xingchengle《huazhuangpinjinyongyuanliaomulu》he《huazhuangpinjinyongzhi(dong)wuyuanliaomulu》。jinghuazhuangpinbiaozhunzhuanjiaweiyuanhuiquantihuiyishenyitongguo,xianyuyifabu,bengonggaozifabuzhiriqishixing。

      《huazhuangpinjinyongyuanliaomulu》gongji1284zhongyuanliao,xiangjiao《biao1 huazhuangpinjinyongyuanliaomulu(zhengqiuyijiangao)》zhuyaoyouyixiadiaozheng:

  • 糾正編號排序
  •  分類合并

         i.  jiangsaikeliqinjiqiyanlei(cyclizine (inn) (cas no. 82-92-8) and its salts)narukangzuanyao

         ii.  jiangmahuangjianjiqiyanlei(ephedrine (cas no. 299-42-3) and its salts)、yibingshenshangxiansu(isoprenaline (inn) (cas no. 7683-59-2))、naijiazuolinjiqiyanlei(naphazoline (inn) (cas no. 835-31-4) and its salts)、qujiashenshangxiansujiqiyanlei(noradrenaline(cas no. 51-41-2) and its salts)、aotuojunjiqiyanlei(octodrine (inn) (cas no. 543-82-8) and its salts)narushenshangxiansushoutijidongyao

        iii. jiangpalamisong(paramethasone (inn) (cas no. 53-33-8))narujisulei

        iv.jiangduanganjunsu(thyrothricine (cas no. 1404-88-2))narudaokangganranleiyaowu

  • 新增禁用原料

wuluotuopin

methenamine (cas no. 100-97-0)

guoyangbenjiaxian

benzoyl peroxide (cas no. 94-36-0)

damaerfen

cannabidiol (cas no. 13956-29-1)


《huazhuangpinjinyongzhi(dong)wuyuanliaomulu》shoulu109zhongyuanliao,yu《biao2 huazhuangpinjinyongzhi(dong)wuyuanliaomulu(zhengqiuyijiangao)》xiangbizhuyaoyouyixiadiaozheng:

  •  糾正編號排序
  • 增加土木香根油的禁用條件為用作香料香精成分時
  • 新增禁用植(動)物原料

dama(cannabis sativa)renguo

cannabis sativa fruit

dama(cannabis sativa)ziyou

cannabis sativa seed oil

dama(cannabis sativa)xietiquwu

cannabis sativa leaf extract

火狐體育APP總結

  • 相比原有的IECIC 2015, IECIC 2021主要增加了原料最高歷史使用量信息用于化妝品安全評估的參考依據之一;原有的8783種原料增加到8972種原料,其中包括增補之前審評審核通過的化妝品原料、《化妝品安全技術規范》中未收載于IECIC 2015的限用組分、防腐劑、防曬劑、著色劑、染發劑以及添加IECIC 2015中的類別原料已使用的具體原料。同時也刪除了部分重復原料以及一些無使用歷史且來源不清的原料。
  • 新版的《化妝品禁用原料目錄》和《化妝品禁用植(動)物原料目錄》共收錄1393種成分。新增了23種禁用原料(含禁用動植物原料)。其中包括大麻二酚(Cannabidiol (CAS No. 13956-29-1))和收載于IECIC 2015的3種大麻類物質(大麻(CANNABIS SATIVA)仁果、大麻(CANNABIS SATIVA)籽油、大麻(CANNABIS SATIVA)葉提取物),標志著中國成為首個國際上將大麻二酚(Cannabidiol (CAS No. 13956-29-1))及所有大麻類物質禁用于化妝品的國家。

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