6REACH法规的应对和最新动态(CTI讲师)dod

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,We assure you excellence!,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,Jessica Wu(0755-33683667)wuyijiecti-,CENTRE TESTING INTERNATIONAL,Key Account Support Dept.,REACH,法规的应对和最新动态,WHATS REACH,？,欧洲议会和欧盟理事会,No.1907/2006(EC),法规,European Parliament and the Council of the European Union,REGULATION(EC)No 1907/2006,化学品注册、评估、授权和限制,Registration,Evaluation,Authorisation and Restriction of Chemicals(REACH),颁布：,2006,年,12,月,18,日,Published,：,18 December 2006,实施：,2007,年,6,月,1,日,Came into force,：,1 June 2007,15,章，,141,条款，,17,个附件,总计,849,页,15 Titles,，,141 Articles,，,17Annexe,849Pages(Revision),Problems 企业面临问题,REACH,法规结构,849 pages,15,章节（,Title,）,17,个附件（,Annex,）,繁多的指南（,Guidance,）和解释文件,难以判断自身产品情况,责任与义务难以划分,难以制定应对法规的策略步骤,困惑？,THE PROPERTIES OF REACH,法令性质,Property,适用产品,Scope,管控物质,Object,管控方法,Methods,指令,Directive,法规,Regulation,REACH,化学品注册、评估、授权和限制,RoHS,电气电子设备限制使用某些有害物质,几乎所有产品,Almost all products,电气电子产品,Electrical and electron,特定的有害物质,Certain Hazardous Substances,几乎所有化学物质,Almost all substance,限制,Restriction,注册、授权、限制,(,评估,),Registration,Authorisation and Restriction(Evaluation,),REACH KEYWORDS,注册,通报,授权,限制,供应链,信息传递,无管控物质列表，需要根据法规相关条款进行责任判定,.,针对物品中含有的,SVHC,候选列表物质进行管控,针对产品中含有的授权清单物质,(,附件,14),进行管控,针对产品中含有的受限物质,(,附件,17),进行管控,针对产品中含有的,SVHC,候选列表物质进行要求,Substance,物质,A chemical chemical element and its compounds in the natural state or obtained by any manufacturing process,自然状态下或通过生产获得的化学元素及其化合物,。,例如：铅，镉，甲苯等。,Preparation,配制品,制剂,A mixture or solution composed of two or more substances,两种或两种以上的物质组成的混合物或溶液例如：胶水，清洗剂，粘合剂，金属合金，化妆品，油漆等。,化工原料或产品,半成品或成品,Article,物品,An object which during production is given aspecial shape,surface or design which determines its function to a greater degree than does its chemical composition,指一在制造过程中获得特定形状、外观或设计的物体，这些形状、外观和设计比其化学成分更能决定其功能例如：电子产品，衣服，电池，钢笔，玩具等。,化学物质,全面应对，各个击破,ECHA,客户,注册卷宗,授权申请,检测报告,/,自我声明,MSDS,管控对象,?,Chemicals,OBLIGATION OF MANUFACTURER,注册,Registration,通报,*,Notification,授权,Authorisation,限制,Restriction,信息交流,*,Communion,物质,Substance,1t/y,X,附件,XIV,Annex XIV,附件,XVII,Annex XVII,安全数据表或必要信息,SDS or others,配制品,Preparation,配制品中物质,1t/y,Substance in preparation,1t/y,X,物品,Article,物品中有意释放的物质,1t/y,Substance in article intended release,1t/y,SVHC(,候选清单,)0.1%&,1t/y,SVHC(Candidate list)0.1%&,1t/y,SVHC(,候选清单,),0.1%,SVHC(Candidate list)0.1%,有意释放,&,非有意释放,物质有意释放,该物质的释放为物品的最终用途所必需的，如果没有这种释放，该物品不能正常使用,:,记号笔,该物质的释放是为物品的附加功能,:,有香味的橡皮擦,物质非有意释放,物品发挥正常功能不需依靠该物质的释放，该释放在物品的使用或维修阶段偶然发生,:,衣服（染料，芳香胺芳,),废弃物的泄漏,属于物品的构成部分，与包围他的物体构成一个物品，一旦物品破损，液体会产生泄漏，整个物品也就废弃（连同液体）。,此类物品遵循,REACH,法则中关于物品的条例，在破损情况下，按废弃物对待，不需要遵循,REACH,法规。,注册,注,册,范围,非分阶段物质,时间,2008,年,6,月,1,日启动,要求,物质,1t/y,；配置品中的物质,1t/y,；,物品中,有意释放,的物质,1t/y,；,提供资料,1,、注册卷宗；,2,、注册卷宗,+CSR,（,10t/y,）,预,注,册,范围,分阶段物质（,列入欧洲商用化学物质目录（,EINECS,）中的物质，,99%,）,时间,2008,年,6,月,1,日,-2008,年,12,月,1,日,首次制造商或进口商,2009,年,1,月,5,日起可开始提交预注册,要求,物质,1t/y,；配置品中的物质,1t/y,；,物品中,有意释放,的物质,1t/y,；,提供资料,企业信息、物质信息。等简单资料,Products,产品,Substances/Preparation,物质,/,配制品,Article,物品,物质,1t/y,Substance intended to be released?,是否存在有意释放？,无需应对注册,&,预注册,Yes,No,(Pre)Registration,预注册,No,(Pre)Registration,（预）注册思路,豁免,分阶段物质否,Registration,注册,2018,年：,Registration deadlin,199t/y,2013,年：,Registration deadline,100999t/y,2010,年：,Registration deadline,1000t/y,or R50/53 100t/y or CMR 1&2,1t/y,Yes,WHY NEED TO NOTIFY,？,物品,Article,通报判定,通报时间,关键词：,通报 物品,SVHC,0.1%,1,吨,/,年,Keywords:notification,article,SVHC0.1%,one tonne or more per year,2010,年,12,月,1,日之前被列入,SVHC,候选清单的物质，应于,2011,年,6,月,1,日前完成通报。,2010,年,12,月,1,日后列入清单的物质，应在其被列入清单后的,6,个月内完成通报。,UPDATE OF AUTHORISATION,18 FEB.2011 EU issued No 143/2011 in its official communique,came into force on the third day after it published.,物质名称,EC No.,CAS No.,申请截止日期,日落之日,2,4,6-三硝基-5-叔丁基间二甲苯,(二甲苯麝香),201-329-4,81-15-2,2013.2.21,2014.8.21,4,4-二氨基二苯基甲烷(MDA),202-974-4,101-77-9,2013.2.21,2014.8.21,六溴环十二烷（,HBCDD）,221-695-9,247-148-4,3194-55-6,25637-99-4,2014.2.21,2015.8.21,-六溴环十二烷,/,134237-50-6,-六溴环十二烷,/,134237-51-7,-六溴环十二烷,/,134237-52-8,邻苯二甲酸二,(2-乙基已基)酯,(DEHP),204-211-0,117-81-7,2013.8.21,2015.2.21,邻苯二甲酸丁苄酯,(BBP),201-622-7,85-68-7,2013.8.21,2015.2.21,邻苯二甲酸二丁酯,(DBP),201-557-4,84-74-2,2013.8.21,2015.2.21,Products,产品,Article,物品,Substances/Preparation,物质,/,配制品,出口总量,1t/y,应对授权,Authorization,应对通报,Bulletin,Authorization&,Bulletin,应对思路,应对授权,Authorization,SVHC,物质,1000ppm,按照,Dir.67/548/EEC,符合,CMR,标准的物质,-,致癌物质,1,类,&2,类,Carcinogenic category 1 or 2,致畸物质,1,类,&2,类,Mutagenic category 1 or 2,生殖毒性物质,1,类,&2,类,Toxic for reproduction category 1 or 2,按照,REACH,法规附件,XIII,，符合,PBT,或,vPvB,标准的物质,-,持久、生物积累和有毒物质,(PBT),Persistent,bioaccumulative and toxic,强持久和强生物积累物质,(vPvB),Very persistent and very bioaccumulative,按照,REACH,条款,59,所确定的其他危害物质,Other hazardous substance in accordance with Article 59,SVHC,鉴定准则,Criterion,欧盟官方预计约,1500,余种物质符合,SVHC,判定标准。,About 1,500 substances will meet the SVHC criterion.,SVHC,的挑选原则,(SUBSTANCE OF VERY HIGH CONCERN),SVHC LIST,28 OCT.,2008,1,nd,Candidate list of Substance of Very High Concern,No.,物质名称,CAS,No.,常见用途,1,蒽,120-12-7,生产染料