1、REACHREACH法規簡介中英對照法規簡介中英對照Content 1.Overview 概述概述 2.Registration and requirements 注冊和要求注冊和要求 3.Requirement for articles 對一般物品的要求對一般物品的要求 4.Possible SVHC in articles 物品中可能存在的物品中可能存在的SVHC 5.Information collection from supplier 供應商端的信息收集供應商端的信息收集 Chemical Frame work before REACH EU separate chemicals i

2、nto “existing” and new chemicals Cut-off date 1981 European Inventory of existing commerical chemical substances 100,204 chemical substances (Before 1981.9) REACH 主要針對的是月之前的物質的管理。主要針對的是月之前的物質的管理。 European List of notified chemical substances 4,381 chemical substances (After 1981.9) 月以后的新物質需經歐盟嚴格測試和全

3、面風險評估認證月以后的新物質需經歐盟嚴格測試和全面風險評估認證后才能使用。后才能使用。REACHREACH是歐盟針對化學物質的一個新的法規。是歐盟針對化學物質的一個新的法規。 REACH means : 注冊注冊 Registration: the use (in manufacture and for importation) of a substance to register will only be possible if it has been pre-registered and registered ; 評估評估 Evaluation of the registration do

4、ssiers with their test proposal and substance evaluation ;許可許可 Authorisation : every Substance* of Very High Concern (SVHC*) for the human health and the environment will need authorisation to be used ;限制限制 and restriction (of CHemicals) : sometimes certain uses will be limited or prohibited, others

5、 will be authorised. The new REACH chemical regulation by the European Union, for the production, import and use of substances*, entered into force on June 1st 2007. Purpose: Protection of human health& environment Enhance competitiveness of EU chemical industryFocus: High volumes chemicals SVHC

6、 Substance of Very High Concern (SVHC) Industries take responsibilities (Duty of care)2. Registration & requirementsScope 應用范圍應用范圍 Apply to the manufacture, placing on the EU market(including import) or use of chemical substances on their own,in preparations or in articles. 適用于歐盟范圍內歐盟范圍內的物質本身，配制

7、品或物品中物質的制造、投放市場（包括進口）或使用。 Key Elements 主要內容主要內容 Registration of substances =1 t/year Increase information and communication through supply chain Authorisation of substances of high concern(SVHC) Evaluation of some registered substances Restrictions of unacceptable substances Chemical agency to manag

8、e the system Exemptions 豁免物質 放射性物質 海關監管物質 已有相關法規限制 不可分離中間體不穩定或快速反應，沒必要分離 廢棄物廢棄前已經控制 國防用途一般法律無法應用 危險物質的運輸有專門要求Substances exempted from some articles 部分豁免物質 生產或進口1t/y)All the substance:Information to recipient(SVHC0.1%)Notification to EU(if SVHC0.1% & t/y)Information to recipient(SVHC0.1%)Notifica

9、tion to EU(if SVHC0.1% & t/y)Registration the substance (if its 1t/y)（）YesYesNoNo3.Requirement to Articles Reach requirement to common articles, which take the most part of our imported non-food items. 出口玩具（大部分）、電子、電器、家具、出口玩具（大部分）、電子、電器、家具、餐具、紡織品（大部分）、鞋子等等。餐具、紡織品（大部分）、鞋子等等。 Information to recipi

10、ent(SVHC0.1%) Notification to EU (SVHC1t/y & 0.1%) 物品 Articles Examples: textiles, toys,PEM, furniture, tablewares, luggage, shoes .etc. Need provide SVHC substance presence information.SVHC 定義 (SVHC) Substances of Very High Concern： - CMR:Carcinogenic, Mutagenic, Reprotoxic 致癌物、誘導有機體突變的物質、生殖毒性物

11、質致癌物、誘導有機體突變的物質、生殖毒性物質第第1類：已知的物質（苯、聚乙烯、石棉、三氧化二砷）類：已知的物質（苯、聚乙烯、石棉、三氧化二砷）第第2類：應被視為的物質（重鉻酸鉀、對二氨基聯苯偶氮染料）類：應被視為的物質（重鉻酸鉀、對二氨基聯苯偶氮染料） PBT:Persistent, Bio-accumulative and Toxic 持久性、生物累積性和毒性物質持久性、生物累積性和毒性物質 VPVB:very Persistent, very Bio-accumulative 高持久性、高生物累積性物質高持久性、高生物累積性物質 Similar substances,e.g. endocr

12、ine disrupter相似的物質，例如：干擾內分泌的物質（激素）相似的物質，例如：干擾內分泌的物質（激素） Calculating concentration of SVHC 計算計算SVHC濃度濃度 SVHC%= SVHC(g)/ W(g) * 100% SVHC% SVHC的百分比濃度 SVHC(g) SVHC的總重量 W(g) 整個物品的重量SVHC List2008 2008 年年6 6 月月30 30 日歐盟化學品管理局（日歐盟化學品管理局（ECHAECHA）公布了）公布了16 16 種首批受評議的種首批受評議的高關注物質（高關注物質（SVHCSVHC）名單，評）名單，評 議期為

13、議期為45 45 天。天。10 10 月月9 9 日，日，ECHA ECHA 已正式公布其評議結果，共包含已正式公布其評議結果，共包含15 15 項項的的SVHC SVHC 物質正式納入物質正式納入“候選物質清單候選物質清單” 這這1515種物質分別為種物質分別為: : Anthracene 蒽 Diarsenic pentaoxide 五氧化砷 4,4- Diaminodiphenylmethane 4,4-二氨基二苯甲烷 Triethyl arsenate 三乙基砷酸酯 Benzyl butyl phthalate 鄰苯二甲酸丁芐酯 Diarsenic trioxide 三氧化二砷 Bis

14、 (2-ethyl(hexyl)phthalate) (DEHP) 鄰苯二甲酸二（2-乙基己）酯 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 二甲苯麝香 Dibutyl phthalate 鄰苯二甲酸二丁酯 Hexabromocyclododecane (HBCDD) 六溴環十二烷 Cobalt dichloride* 氯化鈷 Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 短鏈氯化石蠟 Sodium dichromate, dehydrate 重鉻酸鈉二水合物 B

15、is(tributyltin)oxide 三丁基氧化錫 Lead hydrogen arsenate 酸式砷酸鉛 4.Possible SVHC in articles 5. Information collection from supplierRoles &Obligations for supply chain partnersINTERMARCHEINTERMARCHEIMPORTERIMPORTERHow to collect information from non-EU suppliers? Mode 1 BOM + individual ingredient table

16、 Mode 2 Integrated Product ingredient tableIntermarche Suppliers are required to provide substance Intermarche Suppliers are required to provide substance information(SVHC) by filling below data sheet to SCA quality information(SVHC) by filling below data sheet to SCA quality manager.manager.Q&A:Do you need to register ?Do you need to register ?Are you EU manufacture or importer ?Are you EU manufacture or importer ?Are you dealing with chemical substances directly ?Are you dealing with chemical substances directly ?Are you dealing with preparation?Are you dealing