火狐体育

背景

2011nian,hanguoduomingyunfuyinganran‘bumingyuanyinfeibing’siwang。cihou,leisibinglibuduanzengjia,rangzhenggehanguoxianrukonghuang。hanguojibingguanlibusuihoujinxingliuxingbingxuediaochaheshiyanhouchuburending,jiashiqishajunjishizuijuxianyideduixiang。bingtongguodongwuxiruduxingshiyanhezhuanjiadeyanjiu,zhengshileshi “jiashiqishajunji”shidaozhiyunchanfudenglihuanbumingfeibingzhisideyuanxiong。zhezhongshajunjizhonghanyouyouduhuaxuewuzhiphmg(juliuyajiajiguayansuanyan),keyinfafeibujibing,yanzhongzhezhisi。

為防止此類公共安全事件的再次發生,經過7年時間籌備, 韓國環境部(MOE)于2018年3月20日,正式頒布了《消費性化學制品及生物殺滅劑安全法》(Consumer Chemical Products and Biocides Safety Act, 又稱K-BPR),并于2019年1月1日正式施行。


K-BPR的定義

1.生物殺滅劑

活性物質:具有消除,無害化或抑制有害生物功能的化學物質、天然物質或微生物。

生物殺滅產品:消滅和抑制有害生物的最終使用的產品(含有一個或多個活性物質或者活性物質混合物)

shengwushamiechanpindejutileibiejianxiabiao:

生物殺滅產品:

生物殺滅產品類型(product type)

1

shajunxiaodujilei

a

riyongshajunji,xiaoduji

b

miezaoji

2

binghaichongfangzhilei

a

mieshuji

b

xiaomie、yizhiqitajizhuidongwudechanpin

c

shachongji

d

xiaomie、yizhiqitawujizhuidongwudechanpin

e

quchongjijiyinyouji

3

fangfujilei

a

chanpinchucunyongfangfuji

b

chanpinbiaomianchuliyongfangfuji

c

xianwei,pige,xiangjiaojijuhecailiaofangfuji

d

mucaifangfuji

e

jianzhucailiaoheshebeifangfuji

f

jiagonghuoxueqieyefangfuji

g

fangfuhebiaobenzhizuoye

4

 qita

a

fangwuchanpin

chuliwupin:shiyongleshengwushamiechanpinchulidewupin,qieshiyongshengwushamiechanpindeyongtubingfeigaiwupindezhuyaoyongtu

2.  消費性化學制品

xiaofeixinghuaxuezhipin:xiaofeixinghuaxuezhipinzhiyongyushenghuochangsuo(liruzhuzhai,bangongshiyijigonggongsheshi)deriyonghuaxuechanpin,yijikenengduirentihuozhehuanjingbaoludehuaxuewuzhi。

xuyaojieshouanquanshenhedexiaofeixinghuaxuezhipin:youhuanjingbuzhidingbingtongbaode,jingyoufengxianpingguhoubeirenweiyoufengxiandexiaofeihuaxuepin。xuyaojieshouanquanshenhedexiaofeihuaxuepindejutileibieruxia:

需要接受安全審核的消費化學品

1

qingjiechanpin

a

qingxiji

b

qingjieji

2

xidichanpin

a

xiyiye

b

piaobaiji

c

zhiwurouruanji

3

xidichanpin

a

tucengji

b

zhuanyongtuliao

c

fangxiuji

d

yuntangfuzhuchanpin

4

zhanheji

a

zhanheji

b

mifengji

5

kongqiqingxinji

a

kongqiqingxinji

b

chuchouji

6

ranliao

a

cailiaoranliao

b

cailiaoyoumo

7

qichebaoyangchanpin

a

qichexiye

b

fangdongye

8

yinshuapin

a

youmo?mofen

b

hongseyinyou

c

xiuzhengdai/xiuzhengye

9

meirongchanpin

a

meirongjiao

b

wenshenyoumo

10

xiaoduchanpin

a

xiaoduchanpin

b

chuzaoji

c

jiashiqixiaoduji

d

chuanranbingxiaoduqijixiaoduji

e

qitayufangxiaoduji

11

shachongji

a

shachongji

b

yufang,xiyinyongweishengshachongji

c

weishengquchongji

d

chuanranbingyufangyongshachongji

e

chuanranbingyufangyongmieshuji

12

fangfuji

a

mucaifangfuji

b

fangfuyongguolvqi

13

qita

a

lazhu

b

ganzaoji

c

renzaopenxue

d

wuye

e

jiashiqiyongxiaofeihuaxuepin

監管范圍

k-bprbushiyongyu

  • 《健康功能食品管理法》規定的健康功能食品;
  • 《軍需品管理法》規定的軍用品;
  • 《農藥管理法》規定的農藥,原藥以及農藥控制器材;
  • 《飲用水管理法》規定的水處理劑;
  • 《飼料管理法》規定的飼料、飼料輔料;
  • 《船舶平衡水管理法》規定的處理物質;
  • 《食品衛生法》規定的食品、食品添加劑、食品器具及包裝
  • 《藥劑法》規定的藥品和動物用藥品
  •  《衛生管理法》規定的衛生用品
  • 《醫療器械管理法》規定的醫療器械
  • 《化妝品法》規定的化妝品;

義務

1.  現有活性物質預通報

ruoqiyexuyaoshengchanhuojinkouyongyushengwushamiejizhongdexianyouhuoxingwuzhi,qiegaichanpinzai2018nian12yue31riqianyijingzaishichangshangliutong,neimegaiqiyexuyaozaishengchanhuojinkouqianyutongbao,yihuodexianyouhuoxingwuzhixukehuanchongqi。zaijinxinghuoxingwuzhiyutongbaoshi,qiyehuanxuyaoshenbaogaiwuzhidechanpinleixing(product type, 4dalei,rudieryebiaoge)。genjuchanpinleixing,qiyekeyihuodebutongshichangdehuanchongqi(huanchongqizuichangkeda10nian)。huanchongqiqijian,qiyekeyizaimeiyouqudexukedeqingkuangxiashengchanhuojinkouyiwanchengyutongbaodexianyouhuoxingwuzhi。

2.  活性物質許可

qiyewanchengxianyouhuoxingwuzhiyutongbaohouxuyaozihuanjingbugongbuhuanchongqizhiriqiyinianneitijiaowuzhixukeshenqingjihua(shenqingrenzhunbeixukecailiaodejihua)。yijingtijiaowuzhixukeshenqingjihuadeqiyezhihouxuyaozhunbeixiangyingwuzhidezhengshishenpicailiao。

jihuashengchanhuojinkouyongyushengwushamiejizhongdexianyouhuoxingwuzhideqiyexuyaotijiaoxiangyingwuzhiziliaobingqudehuanjingbudexuke。genjuwuzhidexingzhi,huoxingwuzhideyouxiaoqiwei5-10nian。qiyexuyaozaiyouxiaoqijiemanqianqudexuke。huoxingwuzhixukedeshujuyaoqiujianxiabiao:

數據要求

聯合提交

測試

shenqingzhedejibenxinxi(ceo,shangyebianhaodeng)

 


wuzhishibiexinxi(wuzhimingcheng,cashao,chengfen,fenzishideng)

● (三批次)

kenenghanyouhuoxingwuzhideshengwushamiechanpinleixing


xianyouhuoxingwuzhiyutongbaohao

 


lihuahuoshengtaidulishuju

baoluxinxi,liruyongtuyijibaolutujing


duirenlei,dongwuhehuanjingdeweihaihuofengxianxinxi

gongxiaoxing

fenleihebiaoqian


yuancailiaohezhizaogongyishuju

 


chulihechuzhihuoxingwuzhidezhuyishixiang


guoneiwaishiyongxinxiyijiguanzhixinxi


huoxingwuzhideanquanxingzongheshuju


ruoshiyongyujianhuashenpitiaojian,xutigongxiangguanzhengmingcailiao


* zhiyouyaoqiu.

3. 生物殺滅產品的授權

youyixiangshengchanhuojinkoushengwushamiechanpinjinxinghanguojingneixiaoshoudeqiyexuyaoqudehuanjingbudeshouquan。shouquandeyouxiaoqixianwei3-10nian。shouquanshixiaohou,ruogaiqiyerengxushengchanhuojinkoushengwushamiejichanpin,zebixuzhongxinhuoqushouquan。huodeshouquandeqiyexuyaoyongyoufuhefalvbiaozhundeshengchanhechucunshebei,quebaochanpindezhiliang。

shengwushamiejichanpindeshujuyaoqiuruxia:

數據要求

測試

shenqingrendejibenxinxi(ceo,shangyebianhaodeng)


chanpinjibenxinxi(mingcheng,leixing,peifang,chengfen,yanfaliyoudeng)

(三批次)

lihuahuoshengtaidulishuju

baoluxinxi(liruyongtujibaolutujing)


duirenlei,dongwujihuanjingdeweihaihuofengxianxinxi

youxiaoxing·duimubiaoshengwudeyouxiaoxing

fenleijibiaoqian


yuancailiao、shengchangongyihechucunsheshixinxi


chulihechuzhidezhuyishixiang(jiliang,youxiaoqixiandeng)


guoneiwaishiyongxinxijiguanzhixinxi


huoxingwuzhideanquanxingzongheshuju


ruoshiyongyujianhuashenpitiaojian,xutigongxiangguanzhengmingcailiao


*  zhiyouyaoqiu.

4.  消毒產品標簽

   yixiaxiangmuxuyaozaichanpinhuobaozhuangbiaomianbiaoming:

  • 產品名稱
  • 產品類型
  • 有效期限
  • 重量及數量
  • 功效
  • 用戶類別及使用范圍
  • 規范用途
  • 生產者/進口商名稱,地址以及聯系方式
  • 標簽上注明兒童保護包裝識別標志
  • 活性物質
  • 若產品中使用了納米材料,則還需要提供納米材料的信息
  • 其他任何化學物質(有毒物質,優先控制化學物質)
  • 產品的危害(象形圖,信號詞等)
  • 使用說明
  • 使用注意事項
  • 批準文號

5. 處理物品

yongyuchuliwupindeshengwushamiechanpinbixuhuodeshouquan。ruoqiyexuyaoshuomingchuliwupindexiaoguojigongxiao,yinggenjubiaoqianzhizuobiaozhunjiangqibiaozhu。

6. 需要接受安全審核的消費化學品

ruoqiyeshengchanhuojinkouxuyaojieshouanquanshenhedexiaofeihuaxuepin,meigesannianxuyaozaizhidingdeceshi/jianyanjigoujinxingchanpinanquanshenhe。zaidedaozhidingjigoudeanquanshenhezhihou,qiyexianghanguohuanjinggongyejishuyanjiusuo(korea environmental industry & technology institute)tijiaoanquanshenhequerenshenqing。

ciwai,ruoqiyeshengchanhuojinkouxuyaojieshouanquanshenhedexiaofeixinghuaxuezhipin,qiechanpindeanquanbiaozhunshangweibeigongbu,neimegaiqiyexuyaoxianghuanjingbutijiaoxiangguanchanpinsuohandehuaxuewuzhiziliao,binghuodeshenpi。jutichanpinruxia:

  • 加濕器消毒劑
  • 傳染病消毒劑及消毒器械
  • 其他預防性消毒劑
  • 驅蟲劑
  • 衛生殺蟲劑
  • 衛生驅蚊劑
  • 傳染病預防用殺蟲劑

ruoqiyedasuanxiaoshouxuyaojieshouanquanshenhedexiaofeixinghuaxuezhipin,qiechanpindeanquanxingyijingdedaoqueren,zegaiqiyexuyaotiejiafuhebiaozhundebiaoqian。

7. 備案及報告

shengchanhuojinkouxuyaojieshouanquanshenhedexiaofeixinghuaxuezhipinhuoshengwushamiechanpinxuyaomeiliangnian(3yue31riqian)xianghuanjingbutongbaoyixiaxinxi:

  • 需要接受安全審核的消費性化學制品或生物殺滅產品:產品中含有的優先控制物質及活性物質的名稱和噸位;
  • 生物殺滅活性物質:生物殺滅活性物質的名稱和噸位

yixiaxinxixuyaocundangshinian:

  • 需要接受安全審核的消費化學品的名稱及噸位;
  • 消費化學品的成分以及混合比率;
  • 生物殺滅產品名稱,產品名以及噸位;
  • 生物殺滅產品中活性物質的成分以及混合比率;
  • 用于處理物品的生物殺滅產品的名稱及含量

緩沖期

活性物質分組信息

leibie

zu 1

zu 2

zu 3

zu 4

baoluchengdu

gao

zhong

zhong

di

shengwushamiechanpinleixing

riyongshajun、xiaoduji

mucaifangfuji

chanpinchucunyongfangfuji

jianzhucailiaoheshebeifangfuji

miezaoji

xiaomie、yizhiqitajizhuidongwu

chanpinbiaomianchuliyongfangfuji

jiagonghuoxueqieyefangfuji

mieshuji

xiaomie、yizhiqitawujizhuidongwu

xianwei,pige,xiangjiaojijuhecailiaofangfuji

fangfujibiaobenzhizuoye

shachongji

fangwuchanpin

quchongjijiyinyouji

*shengwushamiechanpinshouquandehuanchongqi:ruoshengwushamiechanpinzhongdesuoyouhuoxingwuzhidouqudehuanchongqi,neimehuanchongqizaihuoxingwuzhihuanchongqidejichushangzaiyanchang2nian。

時間表

shengwushamiejijianguanshijianbiaoruxia:

豁免

  • 環境部通報的低危害物質;
  • 僅用于研發;
  • 試劑、樣品(不投放市場)僅用于出口

唯一代表

若想保護商業機密,海外生產商或出口商不能將物質信息提供給進口商,那么該進口商不能完成K-BPR。為了解決這一問題,海外生產可以委托有資質的唯一代表(OR),來履行K-BPR規定的進口商義務。OR代表功能將于2021年1月1日起生效。

K-BPR服務清單

Category目錄

服務項目


活性物質


  • 現有活性物質預通報
  • 提交現有活性物質審批申請計劃
  • 活性物質許可卷宗的編制和準備
  • 物質等效數據的準備
  • CICO 管理
  • 數據缺口分析
  • 聯系海內外數據持有人
  • 化學品安全報告編制
  • 測試安排調度
  • 答疑解惑
  • 唯一代表(~2021.1.1)
  • 備案及報告 (每兩年,  3月31日前)

shengwushamiechanpin

  • 生物殺滅產品授權卷宗的編制和準備
  • 產品相似數據的準備
  • CICO 管理
  • 購買已獲許可的活性物質的LoA
  • 測試安排調度
  • 生物殺滅產品風險評估工作
  • 生物殺滅產品標簽審核
  • 唯一代表 (~’2021.1.1)
  • 備案及報告(每兩年,  3月31日前)

shengwushamiechanpinchuliwupin

·shengwushamiechanpinchuliwupinbiaoqianshenhe

需要接受安全審核的消費化學品
  • 確認產品分組以及適用于產品的法規
  • 安全檢查的測試安排
  • 為需要接受安全審批的消費化學品申請審批(產品的安全標準未公布)
  • 對需要接受安全審核的消費化學品的安全審核聲明進行審查
  • 安全標準合規審核(容器,包裝及重量)
  • 備案及報告(每兩年,  3月31日前)
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