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化妆品新原料注册备案资料管理规定(2021年第31号)

FABUSHIJIAN:2022-03-04  LIULAN:CI

国家药监局关于发布《化妆品新原料注册备案资料管理规定》的公告(2021年第31号)

国家药监局关于发布《化妆品新原料注册备案资料管理规定》的公告(2021年第31号)


FABUSHIJIAN:2022-03-04

  WEIGUANCHELUOSHI《HUAZHUANGPINZHUCEBEIANGUANLIBANFA》,GUIFANHEZHIDAOHUAZHUANGPINXINYUANLIAOZHUCEYUBEIANGONGZUO,GUOJIAYAOJIANJUZHIDINGLE《HUAZHUANGPINXINYUANLIAOZHUCEBEIANZILIAOGUANLIGUIDING》,XIANYUGONGBU,ZI2021NIAN5YUE1RIQISHIXING。

  TECIGONGGAO。

  FUJIAN:

 

国家药监局
2021年2月26日

 

  附件:

化妆品新原料注册备案资料管理规定
(2021年第31号)

  第一条 为规范化妆品新原料注册和备案管理工作,保证化妆品质量安全,根据《化妆品监督管理条例》《化妆品注册备案管理办法》,制定本规定。

  第二条 化妆品新原料注册人、备案人申请化妆品新原料注册或者进行备案时提交的资料,应当符合本规定要求。

  第三条 化妆品新原料注册和备案资料应当以科学研究为基础,客观、准确地描述新原料的性状、特征和安全使用要求。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGANYAOQIUTIJIAOHUAZHUANGPINXINYUANLIAOZHUCEHEBEIANZILIAO,BINGDUISUOTIJIAOZILIAODEHEFAXING、ZHENSHIXING、ZHUNQUEXING、WANZHENGXINGHEKEZHUISUXINGFUZE。

  第四条 化妆品新原料注册和备案资料应当使用国家公布的规范汉字。除注册商标、网址、专利名称、境外企业的名称和地址等必须使用的其他文字,以及我国法规文件中使用的英文缩写简称等外,所有使用其他文字的资料均应当完整、规范地翻译为中文,并将原文附在相应的译文之后。

  第五条 化妆品新原料注册和备案资料的签章应当符合我国相关法律法规规定,确保签章齐全,具有法律效力。境外企业及其他组织不使用公章的,应当由法定代表人或者授权签字人签字。授权委托签字的,应当提交授权委托书原件及其公证书原件,授权委托书中应当写明授权签字的事项和范围。

  CHUZHENGFUZHUGUANBUMENHUOZHEYOUGUANJIGOU、JIANYANJIANCEJIGOU、GONGZHENGJIGUANDENGCHUJUDEZILIAOYUANJIANWAI,ZHUCEHEBEIANZILIAOJUNYINGDANGYOUJINGNEIZHUCEREN、BEIANRENHUOZHEJINGNEIZERENRENZHUYEJIAGAIGONGZHANG。YONGHUSHIYONGDAIYOUDIANZIJIAMIZHENGSHUGONGZHANGDE,KEZHIJIEZAIDIANZIZILIAOSHANGJIAGAIDIANZIGONGZHANG。

  第六条 化妆品新原料注册和备案资料应当使用我国法定计量单位,使用其他计量单位的,应当折算为我国法定计量单位;应当规范使用标点符号、图表、术语等;参考文献引用应当准确有效,标明出处,确保有效溯源。

  第七条 化妆品新原料注册和备案资料中文本主体文字颜色应当为黑色,内容易于辨认,设置合适的行间距和页面边距,确保在打印或者装订中不丢失文本信息。

  ZHUCEHEBEIANZHIZHIZILIAOYINGDANGSHIYONGGUOJIBIAOZHUNA4XINGGUIGEZHIZHANG,NEIRONGWANZHENGQINGXI、BUDETUGAI。ZHIZHIWENJIANZILIAODEZAITIHESHUXIECAILIAOYINGDANGFUHENAIJIUXINGDEYAOQIU。

  第八条 化妆品新原料注册人、备案人或境内责任人应当按照规定,通过化妆品新原料注册备案信息服务平台(以下简称信息服务平台)申请注册或进行备案,信息服务平台中填写、上传的注册和备案资料电子版应当与纸质版保持一致。

  第九条 化妆品新原料注册人、备案人在申报新原料注册或进行新原料备案前,应当通过信息服务平台,填报以下信息,进行用户信息登记:

  (YI)HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENXINXI;

  (ER)HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENANQUANFENGXIANJIANCEHEPINGJIATIXIGAISHU(YANGLIJIANFU1);

  (SAN)HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENWEIJINGWAIDE,YINGDANGYOUJINGNEIZERENRENTIANBAOXINXI,TONGSHITIJIAOJINGNEIZERENRENSHOUQUANSHUJIQIGONGZHENGSHUDEYUANJIAN。

  TONGYIJINGNEIQIYETONGSHIJUYOUHUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENDENGDUOZHONGSHENFENDE,HUOJINGSHOUQUANZUOWEIDUOGEJINGWAIHUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENDEJINGNEIZERENRENDE,KEYICIXINGTIJIAOQUANBUXIANGGUANZILIAOHOUQUDEXIANGYINGDEYONGHUQUANXIAN。YIYOUYONGHUKEYIGENJUSHIJIQINGKUANGBUCHONGTIGONGXIANGGUANZILIAO,ZENGJIAYONGHUQUANXIAN。

  第十条 化妆品新原料注册人、备案人或境内责任人的以下信息资料发生变化时,应当进行更新,确保信息服务平台中的相关信息资料真实准确:

  (YI)HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENDEFADINGDAIBIAOREN、LIANXIFANGSHIDENGXINXIFASHENGBIANHUASHI,YONGHUYINGDANGZAIXINXIFUWUPINGTAISHANGJISHIZIXINGGENGXIN;

  (ER)HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENDEQITAJIBENXINXI、XINYUANLIAOANQUANFENGXIANJIANCEHEPINGJIATIXIGAISHU、JINGNEIZERENRENDESHOUQUANFANWEIHESHOUQUANQIXIANFASHENGBIANHUADE,YINGDANGTIJIAOHUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENXINXIGENGXINBIAO(YANGLIJIANFU2),BINGANYAOQIUTIJIAOXIANGGUANZILIAOHOUWANCHENGXIANGGUANXINXIZILIAODEGENGXIN。

  QIZHONG,JINGWAIZHUCEREN、BEIANRENMINGCHENG、DIZHIFASHENGBIANHUADE,YINGDANGTIGONGYOUSUOZAIGUO(DIQU)ZHENGFUZHUGUANBUMENHUOZHEYOUGUANJIGOUCHUJUDEZHUTIWEIFASHENGBIANHUADEXIANGGUANZHENGMINGWENJIANYUANJIAN,WUFATIJIAOYUANJIANDE,YINGDANGTIGONGYOUZHONGGUOGONGZHENGJIGUANGONGZHENGDEHUOYOUWOGUOSHI(LING)GUANQUERENDEFUYINJIAN;JINGNEIZERENRENMINGCHENG、DIZHIFASHENGGAIBIANDE,YINGDANGTIGONGWOGUOZHENGFUZHUGUANBUMENHUOZHEYOUGUANJIGOUCHUJUDEZHUTIWEIFASHENGBIANHUADEXIANGGUANZHENGMINGWENJIANYUANJIAN。

  JINGNEIZERENRENSHOUQUANFANWEIGAIBIANDE,XINSHOUQUANFANWEIYINGDANGBAOKUOYUANSHOUQUANFANWEI;JINJINXINGSHOUQUANQIXIANGENGXINDE,SHOUQUANSHUQITANEIRONGBUDEGAIBIAN。

  境内责任人变更的,应当提交拟变更境内责任人承担原境内责任人相关各项责任的承诺书,同时提交原境内责任人关于更换境内责任人的知情同意书或者能够证明境内责任人发生变更的已生效法律判决文书。

  第十一条 境内责任人授权书应当至少载明以下内容和信息:

  (YI)HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHEJINGNEIZERENRENMINGCHENG;

  (ER)SHOUQUANHEBEISHOUQUANGUANXI;

  (SAN)SHOUQUANFANWEI;

  (SI)SHOUQUANQIXIAN。

  TONGYIHUAZHUANGPINXINYUANLIAOBUDESHOUQUANDUOGEJINGNEIZERENREN。JINGNEIZERENRENYINGDANGANZHAOSHOUQUANFANWEIKAIZHANZHUCEHEBEIANGONGZUO。JINGNEIZERENRENSHOUQUANSHUSUOZAIMINGDESHOUQUANQIXIANDAOQIHOU,YINGDANGZAISHOUQUANQIXIANJIEMANQIAN30RINEIZHONGXINTIJIAOYANZHANGSHOUQUANQIXIANDESHOUQUANSHUHUOANYAOQIUBANLIJINGNEIZERENRENBIANGENG。

  第十二条 化妆品新原料注册人、备案人申请化妆品新原料注册或办理新原料备案的,应当提交以下资料:

  (YI)ZHUCEREN、BEIANRENHEJINGNEIZERENRENDEMINGCHENG、DIZHI、LIANXIFANGSHI;

  (ER)XINYUANLIAOYANZHIBAOGAO;

  (SAN)XINYUANLIAODEZHIBEIGONGYI、WENDINGXINGJIQIZHILIANGKONGZHIBIAOZHUNDENGYANJIUZILIAO;

  (SI)XINYUANLIAOANQUANPINGGUZILIAO。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGGENJUSUOSHENBAOZHUCEHUOJINXINGBEIANXINYUANLIAODEJUTIQINGXINGFENLEI,ANZHAOHUAZHUANGPINXINYUANLIAOZHUCEHEBEIANZILIAOYAOQIU(FU3)ZHENGLIBINGTIJIAOXIANGYINGDEZHUCEHEBEIANZILIAO。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGJIEHEXINYUANLIAOZHUCEHEBEIANZILIAOXIANGGUANJISHUXINXI,BIANZHIBINGTIGONGYONGYUZHUCEHEBEIANXINXIGONGKAIDEHUAZHUANGPINXINYUANLIAOJISHUYAOQIUZILIAO(YANGLIJIANFU4),ZAIXINYUANLIAOHUODEPIZHUNHUOWANCHENGBEIANHOU,ZUOWEIPIZHUNZHENGSHUHUOBEIANPINGZHENGDEFUJIANDUIWAIGONGBU,GONGSHEHUIGONGZHONGCHAXUNCANYUE。

  第十三条 化妆品新原料研制报告应当按照要求(附5)进行编制,一般应当包括以下内容:

  (YI)YUANLIAOYANFABEIJING,BAOKUOYANFABEIJING、YANFAMUDE、YANFAGUOCHENGJIYANFAJIEGUODENG;

  (ER)YUANLIAOJIBENXINXI,BAOKUOYUANLIAOMINGCHENG、LAIYUAN、ZUCHENG、XIANGDUIFENZIZHILIANG、FENZISHI、HUAXUEJIEGOU、LIHUAXINGZHIDENGXINXI;

  (SAN)YUANLIAOSHIYONGXINXI,BAOKUOYUANLIAOZAIHUAZHUANGPINZHONGDESHIYONGGUIGE、SHIYONGMUDE、SHIYONGHUOSHIYONGFANWEI、ANQUANSHIYONGLIANG、SHIYONGQIXIAN、ZHUYISHIXIANG、JINGSHIYONGYUDENG;YUANLIAOZAIJINGWAISHIYONGYUHUAZHUANGPINDEZHUANGKUANGYIJIPIZHUNZHUANGKUANG;

  (SI)GONGNENGYIJUZILIAO,HUAZHUANGPINXINYUANLIAOGONGNENGYIJUSHIZHINENGGOUZHENGMINGYUANLIAOJUYOUYUSHIYONGMUDEXIANGYIZHIDEXIANGGUANZILIAO,YIBANBAOKUOKEXUEWENXIAN、FAGUIZILIAO、SHIYANSHIYANJIUSHUJU、RENTIGONGXIAOXINGPINGJIASHIYANZILIAODENG;

  (WU)XINYUANLIAOYANZHIXIANGGUANDEQITAZILIAO。

  第十四条 化妆品新原料制备工艺简述应当结合原料来源特征,对原料生产的主要工艺步骤、工艺参数等进行简要描述,并说明生产过程是否可能引入安全性风险物质及其控制措施。不同来源的新原料制备工艺简述编制要求如下:

  (YI)HUAXUEHECHENGYUANLIAOYINGDANGLIECHUJUTIQISHIWU、FANYINGTIAOJIAN、SHIYONGDEZHUJI、FANYINGGUOCHENGDEZHONGJIANCHANWUJIFUCHANWU、ZHONGCHANWUZHONGCANLIUDEZAZHIHUOZHUJIDENG;

  (ER)TIANRANYUANLIAOYINGDANGSHUOMINGYUANLIAOLAIYUAN、JIAGONGGONGYI、TIQUFANGFADENG,BAOKUOQIANCHULIFANGFA、TIQUTIAOJIAN、CHUZAHUOFENLI/CHUNHUAFANGFA、SHIYONGDERONGJI、KENENGCANLIUDEZAZHIHUORONGJIDENG;

  (SAN)SHENGWUJISHULAIYUANYUANLIAOYINGDANGSHUOMINGPEIYANG、TIQU、FENLI、CHUNHUADENGYUANLIAOZHIBEIGUOCHENG。BAOKUOGONGYIGUOCHENGZHONGKENENGCHANSHENGDEZAZHI、YUANLIAOZHONGKENENGHANYOUDEZAZHIHEKENENGCUNZAIDEYOUHAIWEISHENGWU;

  (SI)QITALAIYUANYUANLIAO,GENJUYUANLIAOTEXINGHEJUTIZHIBEIGUOCHENGTIJIAOXIANGGUANZILIAO。

  第十五条 化妆品新原料质量控制标准应当按照要求(附6)进行编制,一般应当包括以下内容:

  (YI)WENDINGXINGSHIYANSHUJU;

  (ER)ZHILIANGGUIGEZHIBIAOJIQIJIANYANFANGFA;

  (SAN)KENENGCUNZAIDEANQUANXINGFENGXIANWUZHIJIQIKONGZHIBIAOZHUNDENG。

  第十六条 化妆品新原料安全性评价资料一般应当包括毒理学安全性评价资料和安全风险评估资料,并按照下列要求进行编制:

  (YI)DULIXUEANQUANXINGPINGJIAZILIAO,YINGDANGJIEHESHENBAOZHUCEHEJINXINGBEIANXINYUANLIAODETEZHENG,PANDINGXINYUANLIAOYINGDANGSHUYUDEJUTIQINGXING,ANZHAOXIANGYINGDEDULIXUESHIYANXIANGMUZILIAOYAOQIUJINXINGBIANZHI;

  (ER)ANQUANFENGXIANPINGGUZILIAO,BAOKUOYUANLIAOANQUANSHIYONGLIANGPINGGUZILIAOHEYUANLIAOZHONGKENENGCUNZAIDEANQUANXINGFENGXIANWUZHIJIQIKONGZHICUOSHIDENGPINGGUZILIAO。YINGDANGANZHAOGUOJIAYAOPINJIANDUGUANLIJUZHIDINGDEHUAZHUANGPINANQUANPINGGUYUANZEHECHENGXUDENGXIANGGUANYAOQIU,DUIXINYUANLIAOYIJIKENENGTONGSHICUNZAIDEANQUANXINGFENGXIANWUZHIJINXINGPINGGU。

  第十七条 化妆品新原料的样品应当有完整的包装和标签,标签应当包括新原料注册人、备案人或境内责任人名称、原料的中文名称、INCI名称、生产日期和使用期限、贮存条件等信息。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGLIUCUNXINYUANLIAODEYANGPINBEICHA。RUJISHUSHENPINGJIGOUZAIJISHUSHENPINGGUOCHENGZHONGXUYAOCHAKANYANGPINSHI,ZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGZAIGUIDINGSHIXIANNEITIJIAOYANGPIN。

  第十八条 化妆品新原料注册人、备案人或境内责任人应当按照新原料安全监测期相关要求,收集、整理以下信息资料,并根据收集整理的信息资料,编制化妆品新原料安全监测年度报告(附7):

  (YI)SHIYONGXINYUANLIAOSHENGCHANHUAZHUANGPINDEHUAZHUANGPINZHUCEREN、BEIANRENHUOSHOUTUOSHENGCHANQIYEXINXI;

  (ER)SHIYONGXINYUANLIAOSHENGCHANDEHUAZHUANGPINXINXI,BAOKUOCHANPINMINGCHENG,CHANPINZHUCEZHENGSHUHUOBEIANPINGZHENGBIANHAO,CHANPINSHENGCHANHUOJINKOU、XIAOSHOUSHULIANGDENG;

  (SAN)SHIYONGXINYUANLIAOSHENGCHANDEHUAZHUANGPINJIANDUCHOUJIAN、CHACHU、ZHAOHUIQINGKUANG;

  (SI)HUAZHUANGPINSHENGCHANQIYEDUISHIYONGXINYUANLIAOSHENGCHANDEHUAZHUANGPINDEBULIANGFANYINGJIANCEZHIDU、CHANPINBULIANGFANYINGTONGJIFENXIQINGKUANGJICAIQUCUOSHIDENG;

  (WU)HUAZHUANGPINSHENGCHANQIYEDUISHIYONGXINYUANLIAOSHENGCHANDEHUAZHUANGPINDEFENGXIANJIANCEYUPINGJIAGUANLITIXIZHIDUJICAIQUCUOSHIDENG。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGZAIHUAZHUANGPINXINYUANLIAOANQUANJIANCEMEIJIEMANYINIANQIAN30GEGONGZUORINEI,TONGGUOXINXIFUWUPINGTAITIJIAOXINYUANLIAOANQUANJIANCENIANDUBAOGAO。

  第十九条 化妆品新原料注册人、备案人或境内责任人发现新原料使用过程中存在《化妆品注册备案管理办法》规定应当向技术审评机构报告的情况,或其他认为需要报告情形的,应当立即收集整理新原料基本信息、生产和使用情况、安全性问题或突发情况的原因分析、采取的处置措施和处理结果等信息,编制化妆品新原料安全风险控制报告(附8),并通过信息服务平台向技术审评机构提交。

  第二十条 本规定自2021年5月1日起实施。

  附:1.化妆品新原料注册人/备案人安全风险监测和评价体系概述(样例)
    2.化妆品新原料注册人/备案人信息更新表(样例)
    3.化妆品新原料注册备案资料要求
    4.化妆品新原料技术要求(样例)
    5.化妆品新原料研制报告编制要求
    6.化妆品新原料质量控制标准编制要求
    7.化妆品新原料安全监测年度报告编制要求
    8.化妆品新原料安全风险控制报告编制要求

 

  附1

化妆品新原料注册人/备案人安全风险
监测和评价体系概述

(YANGLI)

项目 内容或措施(概述)
岗位职责 请简述化妆品新原料注册人/备案人的安全风险监测和评价相关岗位设置情况,至少包括:
  1. 相关机构和岗位设置情况;
  2. 相关人员基本要求。
安全风险监测 请简述安全风险监测相关制度,至少包括:
  1. 安全风险监测体系的整体构成和运行模式;
  2. 请简述所有主动或被动的有关化妆品新原料的使用和安全情况信息收集渠道,以及信息收集的频率。
安全风险评价 请简述安全风险评价相关制度,至少包括:
  1. 安全风险评价的完成方式,如由化妆品新原料注册人、备案人自行完成或委托相关专业机构完成;
2. 安全风险评价标准;
3. 安全风险评价后相应处置措施。
境外化妆品新原料注册人/备案人,还应简述与境内责任人在安全风险监测和评价方面的信息交流、数据共享、风险联动等方面的机制和措施。境内责任人应简述配合化妆品新原料注册人/备案人进行安全风险监测和评价的具体措施,包括岗位职责设置情况、安全风险监测和评价相关制度。
(化妆品新原料注册人/备案人盖章)
年   月   日
 

  附2

化妆品新原料注册人/备案人信息更新表

(YANGLI)

新原料注册人、备案人:
境内责任人:
资料项目 具体模块 具体项目 更新内容 需提交资料
(一)注册人/备案人信息表 基本信息 □名称(中文)   名称、地址发生变化的,应当提供由所在国(地区)政府主管部门或有关机构出具的主体未发生变化的相关证明文件原件
□名称(外文)  
□住所地址  
□所在国家/地区  
(二)安全风险监测和评价体系概述表 □安全风险监测和评价体系概述表 安全风险监测和评价体系概述表
(三)境内责任人信息表 基本信息 □企业名称    
□住所地址  
□所在地  
(四)境内责任人授权书 □授权范围 (新授权范围应当包括原授权范围) 重新提交境内责任人授权书及相关资料
□授权期限 (授权书其他内容不得改变)
(化妆品新原料注册人、备案人盖章)
年   月   日
 

  附3

化妆品新原料注册备案资料要求

  WEIGENGJIAKEXUE、HELIDIPANDINGHUAZHUANGPINXINYUANLIAODEANQUANFENGXIANCHENGDU,GENJUZAIGUONEIWAIHUAZHUANGPINZHONGSHIYONGLISHI、SHIYONGLISHIDENGQINGKUANG,JIEHEYUANLIAOGONGNENG、XINGZHUANGDENG,DUIXINYUANLIAOJINXINGFENLEI,HUAZHUANGPINZHUCEREN、BEIANRENHUOJINGNEIZERENRENYINGDANGGENJUSUOSHENBAOZHUCEHUOJINXINGBEIANXINYUANLIAODEJUTIQINGXINGFENLEI,ANZHAOYIXIAYAOQIUTIJIAOXINYUANLIAOZHUCEHEBEIANZILIAO。

  一、一般要求

  HUAZHUANGPINXINYUANLIAOZHUCEBEIANZILIAOYINGDANGQINGCHUCHANSHUXINYUANLIAODELAIYUANHEYANZHIQINGKUANG、ZHIBEIGONGYIJIQIZHILIANGKONGZHIQINGKUANGHEANQUANPINGGUQINGKUANGDENGNEIRONG,YINGDANGNENGGOUCHONGFENZHENGMINGZAIXIANDINGDESHIYONGTIAOJIANXIA,JIANGXINYUANLIAOYONGYUHUAZHUANGPINSHENGCHANDEANQUANXINGHEFENGXIANKEKONGXING。

  HUAZHUANGPINXINYUANLIAOZHUCEBEIANZILIAOZHONGYINYONGKEXUEWENXIANHUOFAGUIZILIAO,YINGDANGYUSHENBAOZHUCEHUOJINXINGBEIANDEXINYUANLIAOJUYOUXIANGGUANXING,QIZHONGZAIMINGDEYUANLIAOLAIYUAN、SHIYONGMUDE、SHIYONGGUIGE、SHIYONGFANWEIDENGXIANZHIXINGTIAOJIANYINGDANGSHIYONGYUZHUCEHUOBEIANDEXINYUANLIAO。

  二、检验相关资料要求

  (YI)JIANYANBAOGAOYAOQIU。

  1.JIANYANBAOGAOCHUJUJIGOUYAOQIU。XINYUANLIAOZHUCEREN、BEIANRENYINGDANGANZHAOJIANYANXIANGGUANYAOQIU,ZIXINGHUOZHEWEITUOXIANGGUANJIANYANJIANCEJIGOUDUIXINYUANLIAOKAIZHANBIYAODEJIANYAN,BINGGENJUJIANYANXIANGMUDEXUQIU,XIANGCHENGDANJIANYANGONGZUORENWUDEJIANYANJIGOUTIGONGZHENSHIYOUXIAODEJIANYANYANGPIN。

  LIHUAHEWEISHENGWUJIANYANBAOGAOJIFANGFU、FANGSHAI、QUBANMEIBAI、FANGTUOFAZHIWAIDEGONGNENGPINGJIABAOGAODENGKEYOUHUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENZIXINGHUOZHEWEITUOJUBEIXIANGYINGJIANYANNENGLIDEJIANYANJIANCEJIGOUCHUJU。

  DULIXUESHIYANBAOGAOHEFANGFU、FANGSHAI、QUBANMEIBAI、FANGTUOFAGONGXIAOPINGJIADENGXIANGMUDEJIANYANBAOGAO,YINGDANGYOUQUDEHUAZHUANGPINLINGYUDEJIANYANJIANCEJIGOUZIZHIRENDING(CMA)HUOZHONGGUOHEGEPINGDINGGUOJIARENKEWEIYUANHUI(CNAS)RENKE,HUOZHEFUHEGUOJITONGXINGDELIANGHAOLINCHUANGCAOZUOGUIFAN(GCP)HUOLIANGHAOSHIYANSHICAOZUOGUIFAN(GLP)DENGZIZHIRENDINGHUORENKEDEJIANYANJIGOUCHUJU。

  2.JIANYANBAOGAOSHUYAOQIUYUTILIYAOQIU。CHENGDANHUAZHUANGPINXINYUANLIAOJIANYANGONGZUORENWUDEJIANYANJIGOU,YINGDANGCANZHAOGUOJIAYAOPINJIANDUGUANLIJUFABUDE《HUAZHUANGPINZHUCEHEBEIANJIANYANGONGZUOGUIFAN》DEXIANGGUANGUIDINGYAOQIU,CHUJUXIANGYINGJIANYANXIANGMUDEJIANYANBAOGAO。

  (ER)JIANYANFANGFAYAOQIU。

  1.LIHUAWEISHENGWUHEPINGJIAFANGFAYAOQIU。HUAZHUANGPINXINYUANLIAOLIHUAHEWEISHENGWUJIANYAN、RENTIANQUANXINGHEGONGXIAOPINGJIASHIYANXIANGMU,YUANZESHANGYINGDANGCANKAO《HUAZHUANGPINANQUANJISHUGUIFAN》HUOZHE《ZHONGHUARENMINGONGHEGUOYAODIAN》DENGGUIDINGDEJIANYANFANGFA。《HUAZHUANGPINANQUANJISHUGUIFAN》《ZHONGHUARENMINGONGHEGUOYAODIAN》WEIGUIDINGFANGFADEXIANGMU,YINGDANGANZHAOGUOJIABIAOZHUN、GUOJITONGXINGFANGFAHUOZHESHIYONGZIXINGKAIFADESHIYANFANGFAJINXINGJIANYAN。SHIYONGZIXINGKAIFASHIYANFANGFADE,YINGDANGTONGSHITIJIAOGAIFANGFADESHIYONGXINGHEKEKAOXINGXIANGGUANZILIAO。

  2.DULIXUEFANGFAYAOQIU。XINYUANLIAODULIXUESHIYANXIANGMUYINGDANGANZHAO《HUAZHUANGPINANQUANJISHUGUIFAN》GUIDINGDESHIYANFANGFAKAIZHAN。《HUAZHUANGPINANQUANJISHUGUIFAN》WEIGUIDINGFANGFADEXIANGMU,YINGDANGANZHAOGUOJIABIAOZHUNHUOGUOJITONGXINGFANGFAJINXINGJIANYAN。

  3.DONGWUTIDAIFANGFAYAOQIU。SHIYONGDONGWUTIDAIFANGFAJINXINGDULIXUEANQUANXINGPINGJIADE,YINGDANGGENJUYUANLIAODEJIEGOUTEDIAN、TEDINGDEDULIXUEZHONGDIANXUANZEHESHIDEZHENGHECESHIHEPINGGUFANGFA(IATA)PINGJIAXINYUANLIAODEDUXING。YINGYONGDEDONGWUTIDAISHIYANFANGFASHANGWEISHOULUYUWOGUO《HUAZHUANGPINANQUANJISHUGUIFAN》DE,GAIXIANGTIDAISHIYANFANGFAYINGDANGWEIGUOJIQUANWEITIDAIFANGFAYANZHENGJIGOUYISHOULUDEFANGFA,QIEYINGDANGTONGSHITIJIAOGAIFANGFANENGZHUNQUEYUCEGAIDULIXUEZHONGDIANDEZHENGMINGZILIAO。ZHENGMINGZILIAOYINGDANGBAOKUOGAIXIANGTIDAISHIYANFANGFAYANJIUGUOCHENGJIANSHUHEBUSHAOYU10ZHONGYIZHIDUXINGSHOUSHIWUDEYANJIUSHUJU、JIEGUOFENXI、YANJIUJIELUNDENGNEIRONG。

  三、毒理学安全性评价相关资料要求

  (YI)ZONGTIYAOQIU。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENYINGDANGGENJUSHENBAOZHUCEHUOJINXINGBEIANHUAZHUANGPINXINYUANLIAODEJUTIQINGXING,XUANZESHIDANGDEDULIXUESHIYANXIANGMU,JINXINGDULIXUEANQUANXINGPINGJIA,BINGTIGONGXIANGYINGDEDULIXUEANQUANXINGPINGJIAZILIAO。YINGDANGJIEHEXINYUANLIAOKAIZHANDEDULIXUESHIYANXIANGMU,ZAIZHUXIANGDUIMEIGEDULIXUESHIYANDEFANGFA、SHIYANGUOCHENG、DULIXUEZHONGDIANDENGJINXINGZONGJIEDEJICHUSHANG,DUIXINYUANLIAODEDULIXUEANQUANXINGPINGJIAJINXINGZONGSHU,BINGDECHUANQUANXINGPINGJIAJIEGUO。

  HUAZHUANGPINXINYUANLIAODULIXUEANQUANXINGPINGJIAZILIAOKEYISHIHUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENZIXINGHUOWEITUOKAIZHANDEDULIXUESHIYANXIANGMUDESHIYANBAOGAO、KEXUEWENXIANZILIAOHEGUONEIWAIZHENGFUGUANFANGWANGZHAN、GUOJIZUZHIWANGZHANFABUDENEIRONG。

  (ER)DULIXUESHIYANXIANGMUYAOQIU。

  SHENQINGZHUCEHUOJINXINGBEIANDEHUAZHUANGPINXINYUANLIAO,YUANZESHANGYINGDANGTIGONGYIXIADULIXUESHIYANXIANGMUZILIAO,KEYIGENJUSHENBAOZHUCEHUOJINXINGBEIANXINYUANLIAODEYONGTU、LIHUATEXING、DINGLIANGGOUXIAOGUANXI、DULIXUEZILIAO、LINCHUANGYANJIU、RENQUNLIUXINGBINGXUEDIAOCHAYIJILEISIHUAHEWUDEDUXINGDENGQINGKUANG,ZENGJIAHUOJIANMIANXIANGYINGDEDULIXUESHIYANXIANGMU:

  1.急性经口或急性经皮毒性试验;
  2.皮肤和眼刺激性/腐蚀性试验;
  3.皮肤变态反应试验;
  4.皮肤光毒性试验(原料具有紫外线吸收特性需做该项试验);
  5.皮肤光变态反应试验(原料具有紫外线吸收特性需做该项试验);
  6.致突变试验(至少应当包括一项基因突变试验和一项染色体畸变试验);
  7.亚慢性经口或经皮毒性试验(如果该原料在化妆品中使用经口摄入可能性大时,应当提供亚慢性经口毒性试验);
  8.致畸试验;
  9.慢性毒性/致癌性结合试验;
  10.吸入毒性试验(原料有可能吸入暴露时须做该项试验);
  11.长期人体试用安全试验;
  12.根据原料的特性和用途,需提供其他项目的毒理学试验资料。

  GUONEIWAISHOUCISHIYONGDEYOUJIANKANGWEIHAIXIAOYING(BUBAOKUOJUBUDUXING)DEXINYUANLIAO,YINGDANGTIGONGSHANGSHUDI1~12XIANGDULIXUESHIYANZILIAO,HAIYINGDANGTIJIAODUWUDAIXIEJIDONGLIXUESHIYANZILIAO。

  GUONEIWAISHOUCISHIYONGDEJUYOUJIAOGAOSHENGWUHUOXINGDEGUATAI、DUOTAI、DANBAIZHILEIXINYUANLIAO,YINGDANGTIGONGSHANGSHUDI1~12XIANGDULIXUESHIYANZILIAO,HAIYINGDANGTONGSHITIJIAOPIFUXISHOU/TOUPISHIYANHEMIANYIDUXINGSHIYANZILIAO。

  NAMIXINYUANLIAOYINGDANGTIGONGSHANGSHUDI1~12XIANGDULIXUESHIYANZILIAO,HAIYINGDANGTIGONGGEXIANGDULIXUESHIYANFANGFASHIYONGYUNAMIYUANLIAOJIANCEDESHIYONGXINGSHUOMING。DUINIYONGYUPIFUBUWEIDENAMIXINYUANLIAO,HAIYINGDANGTIGONGPIFUXISHOU/TOUPIXISHOUSHIYANZILIAO;DUIYUYOUKENENGXIRUBAOLUDENAMIXINYUANLIAO,HAIYINGDANGTONGSHITIGONGXIRUDUXINGSHIYANZILIAO。

  (SAN)QINGXINGFENLEIHEXIANGYINGDEZILIAOXIANGMUYAOQIU

  GENJUSHENBAOZHUCEHUOJINXINGBEIANDEXINYUANLIAODEGONGNENG、XINGZHUANG,YIJIZAIGUONEIWAIHUAZHUANGPINZHONGSHIYONGLISHIQINGKUANG,HUOZHESHIYONGLISHIQINGKUANGDENG,XINYUANLIAOFENWEIYIXIALIUZHONGQINGXING,XINYUANLIAOZHUCEREN、BEIANRENYINGDANGJIEHESHENBAOZHUCEHEJINXINGBEIANXINYUANLIAODETEZHENG,PANDINGXINYUANLIAOYINGDANGSHUYUDEJUTIQINGXING,FENBIETIJIAOXIANGYINGDEDULIXUESHIYANXIANGMUZILIAO(XIANGJIANFUBIAO):

  QINGXING1:GUONEIWAISHOUCISHIYONGDEJUYOUFANGFU、FANGSHAI、ZHESE、RANFA、QUBANMEIBAI、FANGTUOFA、QUDOU、KANGZHOU(WULIXINGKANGZHOUCHUWAI)、QUXIE、CHUCHOUGONGNENGYIJIQITAGUONEIWAISHOUCISHIYONGDEJUYOUJIAOGAOSHENGWUHUOXINGDEHUAZHUANGPINXINYUANLIAO,YINGDANGTIJIAOSHANGSHUDI1~12XIANGDULIXUESHIYANZILIAO;

  QINGXING2:GUONEIWAISHOUCISHIYONGDE,BUJUYOUFANGFU、FANGSHAI、ZHESE、RANFA、QUBANMEIBAI、FANGTUOFA、QUDOU、KANGZHOU(WULIXINGKANGZHOUCHUWAI)、QUXIE、CHUCHOUGONGNENGDEXINYUANLIAO,YINGDANGTIJIAOSHANGSHUDI1~7XIANGDULIXUESHIYANZILIAO;

  QINGXING3:BUJUYOUFANGFU、FANGSHAI、ZHESE、RANFA、QUBANMEIBAI、FANGTUOFA、QUDOU、KANGZHOU(WULIXINGKANGZHOUCHUWAI)、QUXIE、CHUCHOUGONGNENGDEXINYUANLIAO,QIENENGGOUTIGONGCHONGFENDEZHENGJUCAILIAOZHENGMINGGAIYUANLIAOZAIJINGWAISHANGSHIHUAZHUANGPINZHONGYIYOUSANNIANYISHANGANQUANSHIYONGLISHIDE,YINGDANGTIJIAOSHANGSHUDI1~6XIANGDULIXUESHIYANZILIAO;

  NENGGOUTONGSHITIGONGGUOJIQUANWEIANQUANPINGJIAJIGOUPINGJIAJIELUNRENWEIZAIHUAZHUANGPINZHONGSHIYONGSHIANQUANDEANQUANPINGGUBAOGAOHUOFUHELUNLIXUETIAOJIANXIADERENTIANQUANXINGJIANYANBAOGAODE,KEBUTIGONGJIXINGJINGKOUHUOJIXINGJINGPIDUXINGSHIYANZILIAO;

  QINGXING4:JUYOUFANGFU、FANGSHAI、ZHESE、RANFA、QUBANMEIBAI、FANGTUOFA、QUDOU、KANGZHOU(WULIXINGKANGZHOUCHUWAI)、QUXIE、CHUCHOUGONGNENG,QIENENGGOUTIGONGCHONGFENDEZHENGJUCAILIAOZHENGMINGGAIYUANLIAOZAIJINGWAISHANGSHIHUAZHUANGPINZHONGYIYOUSANNIANYISHANGANQUANSHIYONGLISHIDEXINYUANLIAO,YINGDANGTIJIAOSHANGSHUDI1~7XIANGDULIXUESHIYANZILIAO;

  QINGXING5:JUYOUANQUANSHIYONGLISHIDEHUAZHUANGPINXINYUANLIAO(YUANLIAOSUOSHIYONGDEBUWEIYINGYUSHIYONGBUWEIYIZHI),YINGDANGTIJIAOSHANGSHUDI2~5XIANGDULIXUESHIYANZILIAO,BINGYINGGENJUYUANLIAODEBAOLULIANG、SHIYONGFANGSHIDENGDUIYUANLIAOJINXINGFENGXIANPINGGU;

  QINGXING6:HUAXUEHECHENGDEYOUYIZHONGHUOYIZHONGYISHANGJIEGOUDANYUAN,TONGGUOGONGJIAJIANLIANJIE,PINGJUNXIANGDUIFENZIZHILIANGDAYU1000DAOERDUN,QIEXIANGDUIFENZIZHILIANGXIAOYU1000DAOERDUNDEDIJUTIHANLIANGSHAOYU10%,JIEGOUHEXINGZHIWENDINGDEJUHEWU(JUYOUJIAOGAOSHENGWUHUOXINGDEYUANLIAOCHUWAI),YINGDANGTIJIAOSHANGSHUDI2XIANGHEDI4XIANGDULIXUESHIYANZILIAO。

  YIYOUGUOJIQUANWEIJIGOUPINGJIAJIELUNRENWEIZAIHUAZHUANGPINZHONGSHIYONGSHIANQUANDEXINYUANLIAO,HUOZHEJINGWAIHUAZHUANGPINJIANGUANBUMENYIJINGPIZHUNSHIYONGDEXINYUANLIAO,YINGDANGFENBIEGENJUSHANGSHUQINGXINGFENLEIDEZILIAOYAOQIU,JIANGGUOJIQUANWEIANQUANPINGJIAJIGOUDEPINGGUBAOGAO、JINGWAIHUAZHUANGPINJIANGUANBUMENPIZHUNZHENGSHUYIJIQITAXIANGGUANZILIAOZHONGXIANGYINGDENEIRONGJINXINGZHENGLIBINGTIJIAO。

  (SI)ANQUANSHIYONGLISHIXIANGGUANZILIAOYAOQIU

  JUBEIYIXIASUOYOUTIAOJIANDE,KEBEISHIWEIZAIJINGWAISHANGSHIHUAZHUANGPINZHONGYIYOUSANNIANYISHANGANQUANSHIYONGLISHIDEXINYUANLIAO,FUHESHANGSHUQINGXING3HEQINGXING4DEXINYUANLIAOYINGDANGTONGSHITIGONGXIANGYINGDEZILIAO:

  1.XINYUANLIAOYUZAIJINGWAISHANGSHIHUAZHUANGPINZHONGSHIYONGDEYUANLIAODEZHILIANGGUIGE、SHIYONGMUDE、SHIYONGHUOSHIYONGFANWEIXIANGTONG,XINYUANLIAODEANQUANSHIYONGLIANGBUGAOYUJINGWAISHANGSHIHUAZHUANGPINZHONGDESHIYONGLIANG;

  2.HANGAIYUANLIAODEHUAZHUANGPINZAIJINGWAISHANGSHIBUDESHAOYU3NIAN;

  3.NENGGOUZHENGMINGHANGAIYUANLIAODEHUAZHUANGPINZAIJINGWAIYIYOUZUGOUSHIYONGRENQUNDEXIANGGUANZHENGJUCAILIAO;

  4.ZAIJINGWAISHANGSHIDEHANGAIYUANLIAODEHUAZHUANGPINWEICHUXIANGUOYINGAIYUANLIAOYINQIDEYANZHONGBULIANGFANYINGHUOZHEQUNTIBULIANGFANYINGSHIJIAN;

  5.WEIJIANGAIYUANLIAOSHEJIKENENGDUIRENTIJIANKANGCHANSHENGWEIHAIXIANGGUANWENXIANBAODAO。

  (WU)ANQUANSHIYONGLISHIXIANGGUANZILIAOYAOQIU

  JUBEIYIXIATIAOJIANZHIYIDE,KEBEISHIWEIJUYOUANQUANSHIYONGLISHIDEXINYUANLIAO,FUHESHANGSHUQINGXING5DEXINYUANLIAOYINGDANGTONGSHITIGONGXIANGYINGDEZILIAO:

  1.QUDEWOGUOXIANGGUANJIANDUGUANLIBUMENSHIPINANQUANRENZHENGHUOQITAXIANGYINGZIZHIDESHIPINYONGYUANLIAO;

  2.JINGGUONEIWAIXIANGGUANJIANDUGUANLIBUMEN、JISHUJIGOUHUOQITAQUANWEIJIGOUFABUDEKEANQUANSHIYONGDEYUANLIAO。

  FUBIAO:HUAZHUANGPINXINYUANLIAOQINGXINGFENLEIHEZILIAOXIANGMUYAOQIU

 

  附表

化妆品新原料情形分类和资料项目要求

                                                   情形分类
                                  / 

资料要求
情形1 情形2 情形3 情形4 情形5 情形6
一、基本信息 1.注册或备案原料信息表
二、研制报告 2.研发背景
3.原料基本信息
4.原料使用信息
5.功能依据资料
6.研制相关的其他资料
三、制备工艺
及质量控制标准
7.制备工艺简述
8.稳定性试验数据
9.质量规格指标及其检验方法
10.可能存在的安全性风险物质及其控制等资料            
四、安全性评价 11.毒理学安全性评价综述
12.急性经口或急性经皮毒性试验    
13.皮肤和眼刺激性/腐蚀性试验
14.皮肤变态反应试验  
15.皮肤光毒性试验            
16.皮肤光变态反应试验            
17.致突变试验    
18.亚慢性经口或经皮毒性试验      
19.致畸试验          
20.慢性毒性/致癌性结合试验          
21.吸入毒性试验            
22.长期人体试用安全试验          
23.其他毒理学试验            
24.安全性评估报告
五、其他资料 25.新原料技术要求





26.可能有助于化妆品新原料注册和备案的其他资料            
 

  ZHU:SHANGBIAOZHONGHUA“○”DE,BIAOSHIBIXUTIJIAOGAIXIANGZILIAO。ZILIAOXIANGMUYAOQIUDESHANGJIAOBIAOZHUHANYIJIESHIRUXIA:

  ① DUIYUJINGWAIYOUSHIYONGLISHIDEXINYUANLIAO,YINGSHUOMINGYUANLIAOZAIJINGWAISHIYONGYUHUAZHUANGPINDEQINGKUANG。

  ② KENENGCUNZAIDEANQUANXINGFENGXIANWUZHIDEXINYUANLIAOYINGDANGTIJIAOGAIXIANGZILIAO。

  ③ ZAIQINGXING3ZHONG,NENGGOUTONGSHITIGONGGUOJIQUANWEIANQUANPINGJIAJIGOUPINGJIAJIELUNRENWEIZAIHUAZHUANGPINZHONGSHIYONGSHIANQUANDEANQUANPINGGUBAOGAOHUOFUHELUNLIXUETIAOJIANXIADERENTIANQUANXINGJIANYANBAOGAODE,KEBUTIJIAOGAIXIANGZILIAO。

  ④ YUANLIAOJUYOUZIWAIXISHOUTEXINGSHIXUTIJIAOGAIXIANGSHIYANZILIAO。

  ⑤ CHUQINGXING6WAI,YUANLIAOJUYOUZIWAIXISHOUTEXINGSHIXUTIJIAOGAIXIANGSHIYANZILIAO。

  ⑥ YUANLIAOYOUKENENGXIRUBAOLUSHIXUTIJIAOGAIXIANGZILIAO。

  ⑦ GENJUMEIGEXINYUANLIAODESHIJIQINGKUANGTIJIAODEQITAZILIAO。

 

  附4

化妆品新原料技术要求

(YANGLI)

  一、基本信息

  (YI)MINGCHENG

  1.标准中文名称
  2.INCI名称及其ID号,或英文等外文名称
  3.化学名称,或动植物原料名称(拉丁学名)
  4.商品名称、别名、缩写等。

  (ER)DENGJIHAO

  1.CAS登记号
  2.EINECS/ELINCS登记号
  3.其他相关登记号

  (SAN)YUANLIAOLAIYUAN

  (SI)YUANLIAOZUCHENG、FENZISHI、HUAXUEJIEGOUJIXIANGDUIFENZIZHILIANGDENG

  (WU)LIHUAXINGZHI

  二、技术要求

  (YI)YUANLIAOSHIYONGMUDE

  (ER)YUANLIAOSHIYONGHUOSHIYONGFANWEI

  (SAN)ANQUANSHIYONGLIANG

  三、其他要求

  (YI)ZHUYISHIXIANG、JINGSHIYONGYU

  (ER)ZHUCUNTIAOJIAN

  (SAN)SHIYONGQIXIAN

 

  附5

化妆品新原料研制报告编制要求

  HUAZHUANGPINXINYUANLIAOYANZHIBAOGAOYIBANYINGDANGBAOKUOYIXIANEIRONG:

  一、研发背景

  BAOKUOYUANLIAOYANFABEIJING、YANFAMUDE、YANFAGUOCHENGJIYANFAJIEGUODENG。

  二、基本信息

  BAOKUOYUANLIAOMINGCHENG、LAIYUAN、ZUCHENG、XIANGDUIFENZIZHILIANG、FENZISHI、HUAXUEJIEGOU、LIHUAXINGZHIDENG。

  (YI)YUANLIAOMINGCHENG。

  YUANLIAOMINGCHENGYIBANBAOKUOYUANLIAOBIAOZHUNZHONGWENMINGCHENG、INCIMINGCHENGJIQIIDHAO、HUAXUEMINGCHENG、DONGZHIWUYUANLIAOMINGCHENG(LADINGXUEMING)、《ZHONGHUARENMINGONGHEGUOYAODIAN》MINGCHENG、CHANGJIANBIEMINGHUOSUOXIEJICASHAOHEEINECS/ELINCSDENGJIHAODENG。

  1.YUANLIAOBIAOZHUNZHONGWENMINGCHENG。《GUOJIHUAZHUANGPINYUANLIAOBIAOZHUNZHONGWENMINGCHENGMULU》ZHONGYIJINGSHOULUDEYUANLIAO,YINGGENJUMULUYUYIMINGQUE;WEISHOULUDEYUANLIAOKECANZHAO《ZHONGHUARENMINGONGHEGUOYAODIAN》DENGQITAQUANWEIMULUZHONGSHOULUDEZHONGWENMINGCHENG,BINGJIEHETONGXINGDEMINGMINGYUANZEZHIDINGYUANLIAOBIAOZHUNZHONGWENMINGCHENG。

  2.YUANLIAOINCIMINGCHENGJIQIIDHAO。YIJINGBEI《GUOJIHUAZHUANGPINYUANLIAOZIDIANHESHOUCE》SHOULUDEYUANLIAO,YINGDANGMINGQUEYUANLIAODEINCIYINGWENMINGCHENGHEDUIYINGDEIDHAOMA;WEIBEISHOULUDE,TIGONGXIANGYINGDEYINGWENMINGCHENG。

  3.QITAMINGCHENG。BAOKUOHUAXUEMINGCHENG、DONGZHIWUYUANLIAOMINGCHENG(LADINGXUEMING)、KUANGWUMINGCHENG、GUANGFANSHIYONGDEBIEMING、SUCHENG、SHANGPINMING、SUOXIEDENG。

  (ER)YUANLIAOLAIYUAN。

  1.XINYUANLIAOLAIYUANBAOKUOHUAXUEYUANLIAO、ZHIWUYUANLIAO、KUANGWUYUANLIAO、SHENGWUJISHUYUANLIAO(RUJIYINGONGCHENG、XIBAOGONGCHENG、FAJIAOGONGCHENG、MEIGONGCHENGHEDANBAIZHIGONGCHENGLAIYUANDENG)DENG。

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENYINGDANGDUISHENBAOZHUCEHEJINXINGBEIANDEHUAZHUANGPINXINYUANLIAODELAIYUANYUYIMINGQUE,BINGGENJUYUANLIAOLAIYUAN,TIGONGXIANGYINGDEJIBENXINXI。

  2.XINYUANLIAOYINGDANGSHIDANYILAIYUAN,BUYINGSHIJINGGUOWULIFANGFAHUNHEERCHENGDEFUPEIYUANLIAO,ZAIYUANLIAOSHENGCHANHUOZHIBEIGUOCHENGZHONGYOUYUJISHUSHANGBUKEBIMIANYUANYINDAOZHIDUOZHONGCHENGFENTONGSHICUNZAIDECHUWAI。RU:WEIBAOHUYUANLIAOERTIANJIADERONGJI、FANGFUJI、WENDINGJIDENGCHENGFEN,HUOTONGGUOHUAXUEFANYINGHUOFAJIAOGUOCHENGBUKEBIMIANCHANSHENGDEYUYUANLIAOTONGSHICUNZAIDEQITACHENGFENDENGQINGXING。

  ZAIYUANLIAOSHENGCHANHUOZHIBEIGUOCHENGZHONGYOUYUJISHUSHANGBUKEBIMIANYUANYINDAOZHIDUOZHONGCHENGFENZAIDE,HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENHAIYINGDANGTIGONGLIANGZHONGHUOLIANGZHONGYISHANGCHENGFENBUKEBIMIANGONGTONGCUNZAIDEXIANGGUANYANJIUZILIAO、YUANLIAOZUCHENGJIXIANGGUANBILI。

  (SAN)ZUCHENG、JIEGOUJICHENGFENJIANDING。

  1.YOUMINGQUEHUAXUEJIEGOUDEYUANLIAOYINGDANGTIGONGHUAXUEJIEGOUHEXIANGDUIFENZIZHILIANG,YIJIHUAXUEJIEGOUDEQUERENYIJU(RUHECIGONGZHENPUTU、YUANSUFENXI、ZHIPU、HONGWAIPUTUDENG)、JIANCEBAOGAO;JUHEWUHAIYINGDANGTIGONGJUHEDUYIJIPINGJUNXIANGDUIFENZIZHILIANGJIQIFENBUDEJIANCEFANGFAHEJIEGUO;SHENGWUJISHULAIYUANYUANLIAOYINGGENJUBENSHENTEXINGSHEDINGJIANBIEFANGFA。

  2.WUMINGQUEHUAXUEJIEGOUDEYUANLIAOYINGSHUOMINGYUANLIAODEZUCHENGCHENGFEN,BINGTIGONGJIANBIECANSHU、JIANDINGFANGFAHEJIANDINGBAOGAO。

  (SI)LIHUAXINGZHI。

  1.GENJUYUANLIAODEXINGZHI,TIGONGXINGZHUANGZHIBIAOBAOKUOYANSE、QIWEI、ZHUANGTAI,JIQITAXIANZHUTEXING(RUKERANXING、RONGJIEXING、XISHIXINGDENG),BINGJIEHEYUANLIAOXINGZHIXUANZEQITALIHUAZHIBIAOXIANGMU,RURONGDIAN、FEIDIAN、BIZHONG、ZHANDU、pHZHI、ZHEGUANGLV、XUANGUANGDU、QIANGZHI、DIANZHI、ZAOHUAZHI、SUANZHI、pKaZHI、FENPEIXISHU(LogPow)DENG。

  2.NAMIYUANLIAO:CHUTIGONGSHANGSHULIHUAZHIBIAOWAI,HAIYINGDANGTIGONGLIZIDAXIAOHEFENBU、YUANLIAODEJUJIHETUANJUTEXING、BIAOMIANHUAXUEXINXI、XINGTAIXUEXINXIDENGTEYIXINGCANSHU。

  NAMIYUANLIAOSHIZHIZAISANWEIKONGJIANJIEGOUZHONGZHISHAOYOUYIWEICHUYU1ZHI100NAMICHICUNHUOYOUTAMENZUOWEIJIBENDANYUANGOUCHENGDEBURONGHUOSHENGWUBUKEJIANGJIEDERENGONGYUANLIAO。

  三、原料使用信息

  BAOKUOYUANLIAOZAIHUAZHUANGPINZHONGDESHIYONGGUIGE、SHIYONGMUDE、SHIYONGHUOSHIYONGFANWEI、ANQUANSHIYONGLIANG、SHIYONGQIXIAN、ZHUYISHIXIANG、JINGSHIYONGYUDENG;YUANLIAOZAIJINGWAISHIYONGYUHUAZHUANGPINDEZHUANGKUANGYIJIHUODEPIZHUNDEQINGKUANG。

  四、原料功能依据资料

  XINYUANLIAODEGONGNENGYIJUZILIAOYIBANBAOKUOKEXUEWENXIAN、FAGUIZILIAO、SHIYANSHIYANJIUSHUJU、RENTIGONGXIAOXINGPINGJIASHIYANZILIAODENG,JUTIYAOQIURUXIA:

  (YI)KEXUEWENXIAN。

  KEXUEWENXIANZILIAOZHUYAOBAOKUOGONGKAIFABIAODEFEIZONGSHUXINGZHIDEXIANGGUANYANJIUXINGLUNWENHUOKEXUEZHUZUO,SUOTIGONGDEWENXIANZILIAOYINGDANGYUZHUCEHUOBEIANDEXINYUANLIAOGONGNENGJUYOUZHENGXIANGGUANXING。

  TIJIAOWENXIANZILIAOSHI,YINGDANGTONGSHITIJIAOYUWENXIANZILIAOZAIMINGXIANGGUANNEIRONGDUIYINGYIZHIDEYUANLIAOYANJIUGUOCHENGJIANSHU、YANJIUJIEGUO、JIEGUOFENXIJIJIELUNDENG。

  (ER)FAGUIZILIAO。

  FAGUIZILIAOZHUYAOBAOKUOZAIGUONEIWAIJIANGUANBUMENHUOJISHUBUMENFABUDEBIAOZHUN、MULU、DIANJI、ZHUZUODENG,YINGDANGTIGONGFAGUIZILIAOZAIMINGDEYUANLIAOJUTIQINGKUANG,RUSHIYONGNONGDU、SHIYONGFANWEI、QITAXIANZHITIAOJIANDENG。

  YINYONGGUOWAIJIANGUANBUMENFABUDEHUAZHUANGPINFAGUIZHONGZAIMINGDEGONGNENGYUANLIAOZHENGMIANQINGDANDE,YINGDANGTIJIAOFAGUIMINGCHENG、FABUGUOJIA(DIQU)HEFABUREN、FABUSHIJIANJIQIXIANGGUANFAGUIQUANWENDENGXINXI,TONGSHITIJIAOZHUCEHUOBEIANDEXINYUANLIAOWANQUANFUHEXIANGGUANFAGUIZAIMINGDEYUANLIAOSHIYONGNONGDU、FANWEIJIQITAQUANBUXIANZHITIAOJIANYAOQIUDEQINGKUANGSHUOMING。

  (SAN)SHIYANSHIYANJIUSHUJU。

  YANJIUSHUJUZHUYAOBAOKUOLIHUAWEISHENGWUSHIYAN、TIWAISHIYANHUODONGWUSHIYANJIEGUO。SUOXUANSHIYANMOXINGYINGDANGHELICHENGXIANHEMONIXINYUANLIAOGONGNENGDETIWAISHIYONGQINGKUANG。

  YITIWAIHUODONGWUSHIYANJIEGUOZUOWEIYANJIUSHUJUZILIAODE,HUAZHUANGPINXINYUANLIAOZHUCERENBEIANRENYINGDANGTIGONGSUOYONGSHIYANMOXING、SHIYANFANGFA、XINYUANLIAOJUYOUZHUCEHUOBEIANXINYUANLIAOGONGNENGYOUXIAOLIANGHEANQUANSHIYONGLIANGDEXIANGGUANSHIYANSHUJU、JIEGUOJIJIELUNDENGZILIAO,BINGCHANMINGXINYUANLIAOJUYOUXIANGGUANGONGNENGDEJIZHI。

  (SI)RENTIGONGXIAOXINGPINGJIASHIYANZILIAO。

  YINGDANGCANZHAOGUOJIAYAOPINJIANDUGUANLIJUZHIDINGDEHUAZHUANGPINGONGXIAOXUANCHENGPINGJIAYUANZEHECHENGXUDENGXIANGGUANYAOQIUKAIZHANSHIYAN,BINGTIGONGSHIYANFANGFA、SHOUSHIZHELISHU、DUIZHAOZUSHEJI、XINYUANLIAOJUYOUZHUCEHUOBEIANGONGXIAOYOUXIAOLIANGHEANQUANSHIYONGLIANGDEXIANGGUANSHIYANSHUJU、SHIYANJIEGUOJIFENXIDENGZILIAO。SHIYANSHOUSHIWUZHONGDEGONGXIAOCHENGFENYINGDANGJINWEIZHUCEHUOBEIANDEXINYUANLIAO。JINXINGRENTISHIYANQIANYINGBAOZHENGSHOUSHIWUYIHUODEDEDULIXUESHUJUHEBAOLUTIAOJIAN、XINXIDENGNENGGOUMANZUQIZAIRENTISHIYONGDEANQUANXING,JINZHIJIANGYOUANQUANYINHUANDESHOUSHIWUYONGYURENTIGONGXIAOXINGPINGJIASHIYAN。

  SHANGSHUXINYUANLIAODEGONGNENGYIJUZILIAOKEYITONGGUODANXIANGHUOZUHEDEFANGSHI,DECHUSHENQINGZHUCEHUOJINXINGBEIANDEXINYUANLIAOJUYOUSUOXUANCHENGGONGNENGDEMINGQUEJIELUN。XUANCHENGJUYOUFANGFU、FANGSHAI、QUBANMEIBAI、FANGTUOFA、QUDOU、KANGZHOU(WULIXINGKANGZHOUCHUWAI)、QUXIE、CHUCHOUGONGNENGDEXINYUANLIAODEGONGNENGYIJUCAILIAO,YINGDANGZHISHAOBAOKUOSHIYANSHIYANJIUSHUJUHUOZHERENTIGONGXIAOXINGPINGJIASHIYANZILIAO。

  五、新原料研制相关的其他资料

  SHANGSHUYANZHIZILIAOZHONGWEINENGBAOKUODEQITAZILIAO,YINGDANGGENJUSHIJIQINGKUANGTIGONG。

 

  附6

化妆品新原料质量控制标准编制要求

  HUAZHUANGPINXINYUANLIAOZHILIANGKONGZHIBIAOZHUNBAOKUOWENDINGXINGSHIYANSHUJU、ZHILIANGGUIGEZHIBIAOJIQIJIANYANFANGFAYIJIKENENGCUNZAIDEANQUANXINGFENGXIANWUZHIJIQIKONGZHIDENGZILIAO。

  一、稳定性试验数据

  HUAZHUANGPINXINYUANLIAOWENDINGXINGSHIYANZHONGDIANKAOCHAXIANGMUYINGDANGXUANZEZAIBAOCUNQIJIANYIYUBIANHUA,KENENGHUIYINGXIANGXINYUANLIAOZHILIANGANQUANDEXIANGMU,BAOKUODANBUXIANYUGUANCHAYUANLIAOXINGZHUANG(YANSE、QIWEIDENG)、LIHUAXINGZHI、CHENGFENHANLIANGDENGZAIWENDU、SHIDU、GUANGXIANDENGDEYINGXIANGXIASUISHIJIANBIANHUADEGUILV。

  WENDINGXINGSHIYANYIBANBAOKUOPOHUAIXINGSHIYAN、JIASUSHIYAN、ZHANGQISHIYANDENGSHIYANFANGFA。HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENYINGDANGGENJUSUOSHENBAOZHUCEHUOJINXINGBEIANDEXINYUANLIAODETEXING,XUANZETIGONGWENDINGXINGSHIYANSHUJUDELEIXING,BINGGENJUYUANLIAOWENDINGXINGSHIYANJIEGUOQUEDINGYUANLIAODEZHUCUNTIAOJIANHESHIYONGQIXIAN。

  DUIYUGUONEIWAISHOUCISHIYONGDEXINYUANLIAO,YINGDANGTIJIAOZHISHAO3PIYUANLIAODEJIASUSHIYANHUO1NIANYISHANGDEZHANGQIBAOCUNSHIYANZILIAO,BINGGENJUYUANLIAODESHIYONGQIXIAN,YICIXINGHUOZHEZAI3NIANJIANCEQINEIZHUNIANBUCHONGTIGONGQISHENGYUSHIYONGQIXIANDEZHANGQIBAOCUNSHIYANZILIAO。

  (YI)POHUAIXINGSHIYAN。

  ZHISHAOTIGONG1PIYUANLIAOZAIGAOWEN(RU60℃)、DIWEN(RU-20℃)、GAOSHI(RU90%RH±5%RH)HUOQIANGGUANGZHAOSHEBAOCUNTIAOJIANXIADEWENDINGXINGSHIYANSHUJU。KEGENJUYUANLIAODETEXINGXUANZEYINGXIANGYINSUHEJUTICANSHUDESHEZHITIAOJIAN。

  (ER)JIASUSHIYAN。

  ZHISHAOTIGONG3PIYUANLIAOZAIYIDINGWENDU、SHIDU(RU40℃±2℃、75%RH±5%RH)BAOCUNTIAOJIANHEBAOCUNQIJIANXIADEWENDINGXINGSHIYANSHUJU。KEGENJUYUANLIAODETEXINGQUEDINGSHIYANTIAOJIAN、BAOCUNQI。

  (SAN)ZHANGQIBAOCUNSHIYAN。

  ZHISHAOTIGONG3PIYUANLIAOZAIYIDINGWENDU、SHIDU(RU25℃±2℃、60%RH±10%RH)BAOCUNTIAOJIANXIA,ZHANGQIBAOCUNDEWENDINGXINGSHIYANSHUJU。KEGENJUYUANLIAODETEXINGQUEDINGSHIYANTIAOJIAN、BAOCUNQI。

  二、质量规格指标及其检验方法

  (YI)YUANLIAOXINGZHUANGJIQIJIANYANFANGFA。

  YUANLIAOXINGZHUANGBAOKUOYANSE、QIWEI、ZHUANGTAIDENG。

  (ER)YUANLIAODELIHUAXINGZHI。

  YINGDANGGENJUYUANLIAOTEXINGTIGONGSHIDANGDELIHUAZHIBIAOYIJIJIANCEFANGFA,RURONGDIAN、FEIDIAN、BIZHONG、ZHANDU、pHZHI、XUANGUANGDUDENG。

  (SAN)DINGXINGJIANBIEFANGFA。

  YINGDANGZHENDUIYUANLIAODEJIEGOUTEDIAN,SHEDINGSHIHEDEJIANBIEFANGFA,RUHONGWAIGUANGPUFA、ZIWAIGUANGPUFA、HECIGONGZHENPUFA、HUAXUEFANYINGFA、SEPUFADENG。

  (SI)YUANLIAOCHUNDUKONGZHIZHIBIAOJIQIJIANYANFANGFA。

  YINGDANGTIGONGYUANLIAODECHUNDUHUOHANLIANG、ZAZHIZHONGLEIYIJIGEZIDEKONGZHIZHIBIAOJIQIJIANYANFANGFA,BINGTIGONGJIANCEBAOGAO。

  YOUYUJISHUYUANYINBUKEBIMIANCUNZAIDERONGJI、FANGFUJI、WENDINGJIDENGDEXINYUANLIAO,YINGDANGTIGONGYUANLIAOZUCHENGJIXIANGGUANBILIDEKONGZHIZHIBIAO。

  (WU)YUANLIAODEBAOZHUANG、YUNSHUHEZHUCUNYAOQIU。

  (LIU)YUANLIAODESHIYONGMUDE、SHIYONGHUOSHIYONGFANWEI、GUIGEJIANQUANDESHIYONGLIANG、ZHUYISHIXIANG、JINGSHIYONGYUDENG。

  三、可能存在的安全性风险物质及其控制标准

  ZAIYUANLIAOZHILIANGGUIGEZHONGSHEDINGSHIDANGDEZHILIANGANQUANXIANZHIZHIBIAOJIJIANCEFANGFA,RUWEISHENGWU、ZHONGJINSHU、YOUHAIWUZHI(RUYOUHAIZUFEN、YOUHAIZAZHI、YOUHAIRONGJIDENG)DENGKONGZHIZHIBIAO。

 

  附7

化妆品新原料安全监测年度报告编制要求

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENYINGDANGANZHAOXINYUANLIAOJIANCEXIANGGUANYAOQIU,JISHISHOUJIXINYUANLIAOSHIYONGDEXIANGGUANXINXI,ANZHAOBENYAOQIUBIANZHIXINYUANLIAOANQUANJIANCENIANDUBAOGAO。

  一、原料基本信息

  BAOKUOXINYUANLIAOZHONGWENMINGCHENG、BEIANHAODENG。

  二、原料生产情况

  (YI)SHENGCHANQIYEMINGCHENG、DIZHI、XIANGGUANZIZHISHUOMINGDENG。

  (ER)XINYUANLIAODENIANSHENGCHANLIANG、XIAOSHOULIANGDENG。

  三、使用新原料的化妆品信息

  (YI)SHIYONGXINYUANLIAODEHUAZHUANGPINQIYEHUIZONG,BAOKUOHUAZHUANGPINQIYEMINGCHENG、SHULIANG,GOUMAIXINYUANLIAODESHULIANG,XIAOSHOUCHANPINDESHULIANGDENG。

  (ER)YILIEBIAOXINGSHI(XIANGJIANBIAO1)LIECHUSHIYONGXINYUANLIAODECHANPINMINGCHENG、PIZHUNWENHAO/BEIANHAO、HUAZHUANGPINZHUCEREN、BEIANREN、SHOUTUOSHENGCHANQIYEMINGCHENG、DIZHIDENGXINXI。

表1 使用新原料的化妆品汇总信息

序号 产品
名称
批准文号/备
案号
化妆品注册人、备案人名称 地址 受托生产
企业名称
生产许可证编号 地址 淋洗或驻留 新原料使用目的 产品生产及销售量
1                    
2                    
3                    
 

  四、使用新原料的化妆品监督抽检、查处、召回情况

  YILIEBIAOXINGSHI(XIANGJIANBIAO2)LIECHUSHIYONGXINYUANLIAODEHUAZHUANGPINJIANDUCHOUJIAN、CHACHUHUOZHAOHUIQINGKUANGDEXIANGGUANXINXI。

表2 使用新原料的化妆品监督抽检、查处或召回情况

时间 情况类型 产品名称 批准文号/备案号 化妆品注册人、备案人 地址 情况简述 备注
  监督抽查            
  查处            
  召回            
 

  五、不良反应监测

  HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENFENBIECHANSHUSHIYONGXINYUANLIAODEBUTONGHUAZHUANGPINZHUCEREN、BEIANRENDEBULIANGFANYINGJIANCEZHIDUJIHUAZHUANGPINBULIANGFANYINGTONGJIFENXIQINGKUANGJICAIQUCUOSHI,BINGXINGCHENGXINYUANLIAOBULIANGFANYINGJIANCEDEHUIZONGFENXIBAOGAO。

  (YI)SHIYONGXINYUANLIAODEHUAZHUANGPINZHUCEREN、BEIANRENDEBULIANGFANYINGJIANCEZHIDUJIANSHEQINGKUANGJIFUZEBULIANGFANYINGJIANCEYUPINGJIAGONGZUORENYUANQINGKUANG;

  (ER)SHIYONGXINYUANLIAODEHUAZHUANGPINBULIANGFANYINGJIANCEQINGKUANGTONGJIQINGKUANG:ZONGLISHU、YANZHONGBULIANGFANYINGLISHU、KENENGYINFAJIAODASHEHUIYINGXIANGDEHUAZHUANGPINBULIANGFANYINGLISHU、SHIFOUSHANGBAOBULIANGFANYINGJIANCEJIGOUDENG;

  (SAN)SHIYONGXINYUANLIAODEHUAZHUANGPINBULIANGFANYINGGELIFENXIPINGJIAQINGKUANG:RUYANZHONGCHENGDU、GUANLIANXINGPINGJIADENG;

  (SI)ZHENDUISHIYONGXINYUANLIAODEHUAZHUANGPINBULIANGFANYINGKAIZHANDIAOCHA、PINGJIAJICAIQUCUOSHIDENGQINGKUANG;

  (WU)XINYUANLIAOBULIANGFANYINGXIANGGUANXINXI:XINYUANLIAOYUHUANZHEBULIANGFANYINGDEFENXIPINGJIA;QITAGUOJIA(DIQU)FAXIANYISIYOUGAIYUANLIAOYINQIDEYANZHONGHUAZHUANGPINBULIANGFANYINGHUOZHEQUNTIBULIANGFANYINGSHIJIANDEQINGKUANGDENG。KETONGSHISUIFUXIANGGUANZILIAO。

  六、风险监测与评价管理

  (YI)SHENGCHANXINYUANLIAOJISHIYONGXINYUANLIAOQIYEDEFENGXIANJIANCEYUPINGJIAGUANLITIXIZHIDUMIAOSHU。

  (ER)CAIQUCUOSHIDENG。

  七、其他需要说明的内容

  DUIYUGUONEIWAISHOUCISHIYONGDEXINYUANLIAOYINGGENJUYUANLIAODESHIYONGQIXIAN,ZAI3NIANJIANCEQINEIZHUNIANBUCHONGTIGONGQISHENGYUSHIYONGQIXIANDEZHANGQIBAOCUNSHIYANZILIAO。

  八、监测报告汇总分析及结论

  DUIJIANCEBAOGAOJINXINGHUIZONGFENXI,XINGCHENGXIANGYINGDEJIELUN。

 

  附8

化妆品新原料安全风险控制报告编制要求

  HUAZHUANGPINXINYUANLIAOSHIYONGGUOCHENGZHONGFAXIANYINGDANGBAOGAOQINGXINGDE,HUAZHUANGPINXINYUANLIAOZHUCEREN、BEIANRENYINGDANGJISHISHOUJIXIANGGUANXINXI,ANZHAOBENYAOQIUBIANZHIXINYUANLIAOANQUANFENGXIANKONGZHIBAOGAO。

  一、基本信息

  BAOKUOXINYUANLIAOZHONGWENMINGCHENG、BEIANHAODENG。

  二、生产情况

  (YI)SHENGCHANQIYEMINGCHENG、DIZHI、XIANGGUANZIZHISHUOMINGDENG。

  (ER)NIANSHENGCHANLIANG、XIAOSHOULIANGDENG。

  三、使用新原料的化妆品信息

  (YI)SHIYONGXINYUANLIAODEHUAZHUANGPINQIYEHUIZONG。BAOKUOQIYEMINGCHENG、XINYUANLIAODESHIYONGMUDE,CAIGOUJISHIYONGSHULIANGDENG。

  (ER)YILIEBIAOXINGSHILIECHUSHIYONGXINYUANLIAODECHANPINMINGCHENG、ZHUCEHAO/BEIANHAO、HUAZHUANGPINZHUCEREN、BEIANREN、SHENGCHANQIYEMINGCHENG、DIZHI、XINYUANLIAOZAICHANPINZHONGDESHIYONGMUDEJITIANJIALIANGDENGXIANGGUANXINXI。

表1 使用新原料的化妆品汇总信息

序号 产品
名称
批准文号/备
案号
化妆品注册人、备案人名称 地址 受托生产
企业名称
生产许可证编号 地址 淋洗或驻留 新原料使用目的及添加量 产品生产及销售量
1                    
2                    
3                    
 

  四、突发情况

  (一)突发情况描述
  包括突发情况原因分析、造成的不良影响和后果等。

  (ER)CAIQUCUOSHI

  (SAN)CHULIJIEGUO

  (SI)GONGZUOJIHUAHEJIANYI

  五、其他需要说明的内容

  RUYOUSHANGSHUXIANGGUANNEIRONGYIWAIXUYAOSHUOMINGDEQITANEIRONG,GENJUSHIJIQINGKUANGYUYISHUOMING。

  六、汇总分析及结论

  DUIBAOGAOJINXINGHUIZONGFENXI,XINGCHENGXIANGYINGDEJIELUN。


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