火狐体育

臺灣既有化學物質標準登錄

法規依據

       taiwan《duxingjiguanzhuhuaxuewuzhiguanlifa》(toxic and concerned chemical substances control act,yixiajianchengtccsca,2019nianxiuding)disanshitiaoguiding,“zhizaohuoshurumeiniandayidingshuliangjiyouhuaxuewuzhizheyingyiguidingqixianxiangzhongyangzhuguanjiguanshenqingdengluhuaxuewuzhiziliao”。tccscadezifa《xinhuaxuewuzhijijiyouhuaxuewuzhiziliaodenglubanfa》(  regulations of new and existing chemical substances registration,yixiajiancheng《banfa》,2019nianxiuding)dishiliutiaoguiding,“zhongyangzhuguanjiguankeyijiyouhuaxuewuzhiziliaodiyijieduandengluqingxing,fenqizhidingyingwanchengjiyouhuaxuewuzhibiaozhundengludemingdan、shuliangjijujidengluqixian。”《banfa》fubiaoliu,tigonglediyiqizhidingyingwanchengbiaozhundengludejiyouhuaxuewuzhimingdan(han106zhongwuzhi)、shuliangjijujidengluqixian。《banfa》fubiaoqi,guidingleshenqingjiyouhuaxuewuzhibiaozhundengluyingtijiaodeziliaoxiangmu。

登錄人與代理人

       yijutccscayu《banfa》youguanguiding,yingwanchengdengludehuaxuewuzhideshengchanshanghuojinkoushangzuoweidengluren。denglurenbixushitaiwanjingneidefarenjigouhuoziranren。denglurenkeyiweituodailirenfuzeshenqingziliao,dailirenbixushitaiwanjingneidefarenjigouhuoziranren。

zhuyi:1、taiwanjingneijinkoushang,zhihaiguanbaoguandanzhongnashuiyiwuren;  2、weituodailirentijiaoshenqingshi,yingtigongjinggongzhengdeweirenshu;3、taiwanjingwaiqiyeruxubaohucbi,taiwanjingneijinkoushangkeyiweirendailiren,youdailirenjinxingdenglushenqing。yishoudailirenshenqingbaomidexinxi,dengluren(taiwanjingneijinkoushang)wufachaxun。

是否需要開展既有化學物質標準登錄?

       tongshifuheyixiasangetiaojiande,xuyaokaizhanjiyouhuaxuewuzhibiaozhundenglu:

       1、yiwanchengjiyouhuaxuewuzhidiyijieduandenglu;

       2、huaxuewuzhilierudiyiqizhidingyingwanchengbiaozhundengludejiyouhuaxuewuzhimingdan;

       3、huaxuewuzhinianzhizaohuoshuruliangda1dunyishang。

臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄

登錄期限規定

完成第一階段登錄的情形

指定應完成標準登錄期限

2019nian12yue31riqianwanchengdiyijieduandenglu

denglunianshuliang1dunyishangweiman100dunde

yu2022nian12yue31riqianwanchengdenglu

denglunianshuliangda100dunyishangde

yu2021nian12yue31riqianwanchengdenglu

2020nian01yue01rihouwanchengdiyijieduandenglu

denglunianshuliang1dunyishangweiman100dunde

yucinian1yue1riqi,3nianneiwancheng。

denglunianshuliangda100dunyishangde

yucinian1yue1riqi,2nianneiwancheng。

wanchengdiyijieduandenglushinianshuliangweiman1dun

yu2019nian12yue31riqian,shijinianshuliangda1dunyishangde

yu2022nian12yue31riqianwanchengdenglu

yu2020nian01yue01rihou,shijinianshuliangda1dunyishangde

yucinian1yue1riqi,3nianneiwancheng。

zhuyi:1、diyijieduandenglumajingzhuxiaohoubingzaicitichushenqing,qudediyijieduandenglumahou,rengyingyuyuanzhidingqixianneiwanchengbiaozhundenglu;ruzaicitichushenqingshiyiyuzhidingqixian,yingzaishenqingshiyibingwanchengbiaozhundenglu。2、diyijieduandenglushinianshuliangda100dunyishang,danyuqibunengyuzhidingqixianneiwanchengzhongfurandu、shengzhi/fayuduxing、weihaipingguhuobaolupinggudengxiangmuziliao,keyuzhidingqixianjiemanqian6geyueqian,xiangzhongyangzhuguanjiguantichushenqing,yanchangwanchengqixian,yanchangqixianzuichangwei1nian。

登錄審查期限及收費

       《banfa》guiding,zhuguanjiguanduijiyouhuaxuewuzhibiaozhundengludeshenchashixianweizishoujianriqi90gegongzuori(ruyouyanqi,xutongzhidengluren,qiezuiduoyanqiyici)。shenchahou,ruxubuchonghuogengzhengziliao,denglurenyingzishoudaotongzhiqi,yu30gegongzuorineitichu。zaiqixianneidenglurenweitichubuzhengziliao,huojingliangcibuzhengziliaohourengweiwanchengbuzhengde,jiangbeibohuishenqing。zhuguanjiguanduibuzhenghuogengzhengziliaodeshencha,zhongxinjisuan90gegongzuori,erbuzhengshijianbujirunei。

       zhuguanjiguanduijiyouhuaxuewuzhibiaozhundenglushouqushenchafei,shoufeibiaozhunwei50000yuanxintaibi/dengluren/wuzhi。ruguodenglurenshuxueshujigouhuozhongxiaoqiyede,jinshouqushenchafeide75%(ji37500yuanxintaibi/dengluren/wuzhi)。

       jiyouhuaxuewuzhibiaozhundenglushi,keduidenglurenxinxi、wuzhibiaoshixinxi、zhizaohuoshuruxinxi、yongtuxinxidengshejigongshangjimide,shenqingbaomi,feiyongweimeixiang12500yuanxintaibi。baomiyouxiaoqiwei5nian。daoqiqian6geyueqisuan3geyuenei,keshenqingyanchang,zuiduobaomiqixianwei10nian。

登錄量級與資料要求

       jiyouhuaxuewuzhibiaozhundenglugongfen4geliangji,ruxia:

       diyiji:nianzhizaohuoshuruliangda1dunyishangweiman10dun;

       dierji:nianzhizaohuoshuruliangda10dunyishangweiman100dun;

       disanji:nianzhizaohuoshuruliangda100dunyishangweiman1000dun;

       disiji:nianzhizaohuoshuruliangda1000dunyishang。

       yinggenjushouciqudediyijieduandenglumashidenianzhizaohuoshurushuliang,quedingdengluliangji。ruguowanchengdiyijieduandengluhou,tigaonianzhizaohuoshurushuliangde,yinggenjushijinianzhizaohuoshurushuliang,quedingdenglujibie。

       jiyouhuaxuewuzhibiaozhundengludejibieyuegao,dengluziliaoyaoqiuyueduo。yixiaweibutongdengluliangjidedengluziliaodaxiangyaoqiu:

資料大項

第一級

第二級

第三級

第四級

1、denglurenjiwuzhijibenbiaoshixinxi

2、wuzhizhizao、yongtujibaoluxinxi

3、weihaifenleiyubiaoqian

4、anquanshiyongxinxi

5、lihuatexingziliaoxiangmu

6、duliziliaoxiangmu

7、shengtaiduliziliaoxiangmu

8、weihaipingguxinxi


9、baolupingguxinxi


zhuyi:1、jiyouhuaxuewuzhirufuhezhiai、shengzhixibaozhitubianhuoshengzhiduxingwuzhi(cmr)di1leiweihaifenleide,xugenjuqinianzhizaohuoshurushuliang,tijiaogaoyiliangjidedengluziliaoxiangmu。2、di5、6、7sangeziliaodaxiang,genjudenglujibiebutong,xutijiaodejutiweihaitexingshujujiedianbutong。

共同登錄

       《banfa》guiding,butongdenglurengongtonghuoxianhoushenqingdenglutongyijiyouhuaxuewuzhide,gedenglurenkexieyishenqinggongtongshiyongdenglusuoxuziliao。denglurenkezixingxuanzedandudengluhuozhegongtongdenglu。

       denglurenxuanzegongtongdenglujiyouhuaxuewuzhibiaozhundenglushi,kegongxiangbiaozhundenglusuoxudedi3、5、6、7、8denggongwugeziliaodaxiang。zaishouweidenglurenwanchengbiaozhundengluhou,qudebiaozhundengluwanchengma,bingxiangqitadenglurentigonggongtongdenglushouquanma。qitagongtongdenglurenshiyonggongtongdenglushouquanma,jinxutigongdi1、2、4、9dengziliaodaxiangneirong,jikewanchengdenglu。

       youyicanyugongtongdengludeqiye,keyijinrujiyouhuaxuewuzhibiaozhundengludegongtongdenglutongxunpingtai,shenqingjiaruwuzhitongxunqunzu,jikeyuqitagongtongdenglurenqudelianxi,xieyigongtongdenglushixiang。

臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄


臺灣既有化學物質預登錄


       taiwanduxinghuaxuewuzhiguanlifa(toxic chem. subs. control act, tcsca)diqitiao“weijianquanguoneigejiguanguanlihuaxuewuzhisuoxuzhiziliao,zhizaohuoshurumeiniandayidingshuliangjiyouhuaxuewuzhizheyingyiguidingqixianxiangzhongyangzhuguanjiguanshenqingdengluhuaxuewuzhiziliao;zhizaohuoshuruxinhuaxuewuzhizheyingyuzhizaohuoshurujiushiriqianxiangzhongyangzhuguanjiguanshendingdengluhuaxuewuzhiziliao。qiankaijiyouhuaxuewuzhijixinhuaxuewuzhijinghezhundengluhou,shidezhizaohuoshuru”。youguangaifadezifa“xinhuaxuewuzhijijiyouhuaxuewuzhiziliaodenglubanfa”yiyu2014nian12yue11rishixing。yixiatidaotcsca,zhuyaojiangshugaifaxiadezifadengluren、fanweidengxiangguanneirong。

      taiwanzhiyeanquanweishengfa(occupational safety and health act, osha)dishisantiao“zhizaozhehuoshuruzheduiyuzhongyangzhuguanjiguangonggaozhihuaxuewuzhiqingdanyiwaizhixinhuaxuewuzhi,weixiangzhongyangzhuguanjiguanjiaojiaohuaxuewuzhianquanpinggubaogao,bingjinghezhundengjiqian,budezhizaohuoshuruhanyougaiwuzhizhihuaxuepin”。youguangaifadezifa“xinhuaxuewuzhidengjiguanlibanfa”yiyu2015nian1yue1rishixing。yixiatidaoosha,zhuyaojiangshugaifaxiadezifadengluren、fanweidengxiangguanneirong。

TCSCA&OSHA登錄人

taiwanjingneideshengchanshanghuoshijinkoushangkezuoweidenglurenzhijiedenglu,shixingyuantouguanli;yekeweirendisanfangjigoutprjinxing,cishixuchujuweirenshu。

**注意**
  • 此處第三方機構TPR不是REACH或是中國新化學物質申報中代理人概念。
  • 臺境外貿易商不能作為登錄人委托TPR進行登錄,但可協助臺境內的進口商進行登錄,可將保密資料直接傳送給TPR.
  • 如果有多個臺灣進口商,建議委托同一個TPR,進行共同登錄。

tpr: third party representative(disanfangdanwei)。yijutaiwantcscadi7-1tiao,jixinhuaxuewuzhijijiyouhuaxuewuzhiziliaodengjibanfadi2tiao,disanfangdanweitprkelvxingsuoyingjuyoudefaguiyiwushiwushangdegongzuo。

TCSCA&OSHA的登錄物質范圍

  • TCSCA登錄范圍:既有化學物質、新化學物質
  • OSHA登錄范圍:新化學物質

如何判定物質是否屬于新化學物質/既有化學物質?

      beilieruzhongyangzhuguanjiguanzhijiyouhuaxuewuzhiqingce(huogonggaoqingdan)zhongdehuaxuewuzhichengweijiyouhuaxuewuzhi,weilierujiyouhuaxuewuzhiqingce(huogonggaoqingdan)zhongdehuaxuewuzhiweixinhuaxuewuzhi。jiyouhuaxuewuzhiqingcezhongshouludewuzhiruxia:

  • 1993.01.01~2011.12 .31間生產或進口的化學物質
  • 2014年12月11日之前生產或進口的化學物質可申請既有化學物質審定(于2015年3月31日截止),進入既有化學物質清冊。
臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄

哪些物質可豁免TCSCA&OSHA的子法登錄?

  1. 天然物質
  2. 伴隨試車用機械或設備之化學物質
  3. 在反應槽或制程中正進行化學反應不可分離之中間產物
  4. 涉及國防需求之化學物質
  5. 海關監管化學物質
  6. 廢棄物
  7. 無商業用途之副產物或雜質
  8. 混合物
  9. 成品
  10. 已列于既有化學物質清冊之適用2%規則或新化學物質符合2%規則之聚合物
  11. 依其他目的事業主管機關有管制規范者之種類,如農藥、肥料等。

TCSCA&OSHA實施時間表

臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄

*jiyouwuzhiyudenglu:tcscadezifa《xinhuaxuewuzhijijiyouhuaxuewuzhiziliaodenglubanfa》di18tiao“zhizaohuoshurujiyouhuaxuewuzhiyushenqingdengluqianlianxusannianzhinianpingjunshuliangda100kgyishang,huoyushenqingdengluqianlianxusannianneirenyinianzhizuigaoshuliangda100kgyishangzhe,yingyu2015nian9yue1riqizhi2016nian3yue31rizhi,shenqingdengluhuaxuewuzhiziliao。qianxiangshenqingjinghezhundengluzhe,youzhongyangzhuguanjiguanfageidiyijieduandengluma”。

TCSCA&OSHA下新化學物質的登錄類型(少量登錄、簡易登錄、標準登錄)

*表中“標錄1”指“1級標準登錄”,標錄2、3、4依次類推。
臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄

登錄資料要求

臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄
**備注**:
  1. 除OSHA 的數據要求里沒有生態毒理資訊;其他數據要求基本一致。
  2. 在TCSCA的標準登錄中,部分測試數據可先以測試計劃書的形式提交。

TCSCA&OSHA子法登錄流程

臺灣,TCSCA,OSHA,既有化學物質,預登錄,標準登錄

臺灣環保署的最新發布的既有化學物質和新化學物質登錄常見問題集錦

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