REACH法规简介中英对照

1、REACHREACH法规简介中英对照法规简介中英对照Content 1.Overview 概述概述 2.Registration and requirements 注册和要求注册和要求 3.Requirement for articles 对一般物品的要求对一般物品的要求 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 供应商端的信息收集供应商端的信息收集 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 主要针对的是月之前的物质的管理。主要针对的是月之前的物质的管理。 European List of notified chemical substances 4,381 chemical substances (After 1981.9) 月以后的新物质需经欧盟严格测试和全

3、面风险评估认证月以后的新物质需经欧盟严格测试和全面风险评估认证后才能使用。后才能使用。REACHREACH是欧盟针对化学物质的一个新的法规。是欧盟针对化学物质的一个新的法规。 REACH means : 注册注册 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 ; 评估评估 Evaluation of the registration do

4、ssiers with their test proposal and substance evaluation ;许可许可 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 应用范围应用范围 Apply to the manufacture, placing on the EU market(including import) or use of chemical substances on their own,in preparations or in articles. 适用于欧盟范围内欧盟范围内的物质本身，配制

7、品或物品中物质的制造、投放市场（包括进口）或使用。 Key Elements 主要内容主要内容 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 豁免物质 放射性物质 海关监管物质 已有相关法规限制 不可分离中间体不稳定或快速反应，没必要分离 废弃物废弃前已经控制 国防用途一般法律无法应用 危险物质的运输有专门要求Substances exempted from some articles 部分豁免物质 生产或进口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）、电子、电器、家具、出口玩具（大部分）、电子、电器、家具、餐具、纺织品（大部分）、鞋子等等。餐具、纺织品（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 定义 (SVHC) Substances of Very High Concern： - CMR:Carcinogenic, Mutagenic, Reprotoxic 致癌物、诱导有机体突变的物质、生殖毒性物

11、质致癌物、诱导有机体突变的物质、生殖毒性物质第第1类：已知的物质（苯、聚乙烯、石棉、三氧化二砷）类：已知的物质（苯、聚乙烯、石棉、三氧化二砷）第第2类：应被视为的物质（重铬酸钾、对二氨基联苯偶氮染料）类：应被视为的物质（重铬酸钾、对二氨基联苯偶氮染料） PBT:Persistent, Bio-accumulative and Toxic 持久性、生物累积性和毒性物质持久性、生物累积性和毒性物质 VPVB:very Persistent, very Bio-accumulative 高持久性、高生物累积性物质高持久性、高生物累积性物质 Similar substances,e.g. endocr

12、ine disrupter相似的物质，例如：干扰内分泌的物质（激素）相似的物质，例如：干扰内分泌的物质（激素） Calculating concentration of SVHC 计算计算SVHC浓度浓度 SVHC%= SVHC(g)/ W(g) * 100% SVHC% SVHC的百分比浓度 SVHC(g) SVHC的总重量 W(g) 整个物品的重量SVHC List2008 2008 年年6 6 月月30 30 日欧盟化学品管理局（日欧盟化学品管理局（ECHAECHA）公布了）公布了16 16 种首批受评议的种首批受评议的高关注物质（高关注物质（SVHCSVHC）名单，评）名单，评 议期为

13、议期为45 45 天。天。10 10 月月9 9 日，日，ECHA ECHA 已正式公布其评议结果，共包含已正式公布其评议结果，共包含15 15 项项的的SVHC SVHC 物质正式纳入物质正式纳入“候选物质清单候选物质清单” 这这1515种物质分别为种物质分别为: : 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 邻苯二甲酸丁苄酯 Diarsenic trioxide 三氧化二砷 Bis

14、 (2-ethyl(hexyl)phthalate) (DEHP) 邻苯二甲酸二（2-乙基己）酯 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 二甲苯麝香 Dibutyl phthalate 邻苯二甲酸二丁酯 Hexabromocyclododecane (HBCDD) 六溴环十二烷 Cobalt dichloride* 氯化钴 Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 短链氯化石蜡 Sodium dichromate, dehydrate 重铬酸钠二水合物 B

15、is(tributyltin)oxide 三丁基氧化锡 Lead hydrogen arsenate 酸式砷酸铅 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