reach和rohs的物质清单

REACH绿色合规——物质清单

下游用户要符合REACH与CLP法规的一个关键步骤是充分了解公司使用或进口的单独的或物品中的物质/混合物。制定物质清单可使公司确定：

• 公司自欧洲供应商采购了哪些物质/配制品及其用途是什么？ 你可以联系化学品供应商，以确保物质/配制品的持续供应，及将公司的物质用途包括在物质的注册卷宗、化学品安全报告及暴露状况中 （参见第5.6节）。 要求供应商提供所有物质与配制品（无论其是否有害）的安全数据表/扩展安全数据表 （或类似安全数据表的文件），是收集数据的一个有效方式。

• 自欧洲以外进口了哪些物质/配制品？ 除非指定了履行进口商义务的非欧洲经济区制造商的“唯一代表”，否则公司必须履行REACH规定的进口商义务。这可能导致物质/配制品中的物质的注册义务。这些情况可能不明显： 例如，如果你从非欧洲经济区供应商进口润滑剂然后供应给你的客户（和设备一起或是作为服务合同的一部分），你可能不得不编制注册数据资料，以获得持续供应那种物质/配制品的许可（第5.4节）。

• 公司采购的物质/配制品具有或不具有安全数据表/扩展安全数据表？ 对于符合特定标准的有害物质/配制品，供应商必须提供安全数据表/扩展安全数据表。如果你收到了安全数据表/扩展安全数据表，你可能需要履行REACH规定的多项义务。这会影响你的生产过程与产品。（ 参见第5.6节 ）

• 公司在欧洲经济区生产的物品中的有意释放物质是什么？ 如果你在欧洲经济区生产含有意释放物质的物品，且供应链中的上游行为人未对此物质 进行预注册/注册，则你必须对在特定条件下释放的这些物质进行注册 （参见第5.8节）。

• 公司进口的物品中的有意释放物质是什么？ 如果非欧洲经济区制造商未指定唯一代表， 则你必须对所进口的物品中的有意释放物质进行后预注册或注册。

A key step for downstream users to comply with the REACH and CLP Regulation is to have a full understanding of what substances/mixtures the company uses or imports either on their own or in articles. Establishing a substance inventory will allow the company to determine:

• Which substances/mixtures the company purchases from a European supplier and for what purpose they are used? You may contact the chemicals supplier to ensure that the substance/mixture will continue to be supplied and that the company’s use will be covered in the substance registration dossier, in the Chemical Safety Report and in an exposure scenario (see Chapter 5.6). An efficient way to collect data is to request suppliers to deliver SDSs/Ext-SDSs (or SDS-like documents) for all substances and mixtures, regardless of whether they are hazardous or not.

• Which substances/mixtures the company imports from outside Europe? Unless an“OR”of a non-Community manufacturer, who will take over the obligations as an importer, has been appointed, you will have to comply with REACH obligations as an importer. This may result in the obligation to go through registration of those substances/substances in mixtures. These cases may not be obvious: for example, if you import a lubricant from a non-EEA supplier in order to supply it to your customer (either with equipment or as part of a service contract), you may be obliged to generate the data package for registration in order to be allowed to continue to supply that substance/mixture (see Chapter 5.4).

• For which substances/mixtures the company purchases, are SDSs/Ext-SDSs are available/not available? For hazardous substances/mixtures that fulfil certain criteria, the supplier has to provide SDSs/ Ext-SDSs. If you have received such SDSs/ExtSDSs, you may have to fulfil several obligations to be REACH compliant. This may have an impact on both your production process and your products. (see Chapter 5.6)

• Which substances are intended to be released from an article that the company produces in the EEA? If you produce articles in the EEA, intentionally releasing substances, without this substance having been pre-registered/registered by an actor up the supply chain, you will be obliged to register the substances released under certain conditions (see Chapter 5.8).

• Which substances are intended to be released from an article that the company imports? If no OR of a non-Community manufacturer has been appointed, you are obliged to do late pre-registration or registration of the substances intentionally released from the article that you import.

• 按照以下标准，哪些进口物质/配制品具有危险性？

• REACH第57条（高关注度物质）

• REACH第67条（限制）

• CLP法规

• 根据法规(EC) 552/2009修改的REACH附录XVII。 根据CLP法规确定物质清单中哪些物质被分类为危险物质，哪些物质在配制品中的浓度大于CLP附录I或REACH附录XVII规定的浓度极限。

• Which imported substances/mixtures are dangerous according to

• Art. 57 REACH (SVHCs)

• Art. 67 REACH (Restriction)

• CLP Regulation

• Regulation (EC) No 552/2009 amending REACH in regard to Annex XVII? Identify substances in the substance inventory which are classified as hazardous under CLP and which are present in a mixture above the concentration limits specified in Annex I of CLP or as specified in Annex XVII of REACH.

• 哪些物品含有危险物质？ 你需要了解这些信息，以便你能够履行REACH通报（REACH第7.2条：参见第5.9 节）、信息传递（REACH第33条：参见第5.10节）、授权（REACH第56条，附录 XIV：参见第5.11节）、和限制（REACH第67条，附录XVII：参见第5.12节）的义务。

• Which articles contain dangerous substances? You need to know this information to be able to fulfil your REACH obligations on Notification (Art. 7.2 REACH: See Chapter 5.9), Communication (Art. 33 REACH: See Chapter 5.10), Authorisation (Art. 56 REACH, Annex XIV: See Chapter 5.11) and Restriction (Art. 67 REACH, Annex XVII: See Chapter 5.12).

• 根据你在REACH的角色，你需要收集以下关键信息，以确定你应履行的REACH义务（如果有）：

物质/配制品名称（供应商的专利或商标 名，如果有）

• 化学名称

• CAS号（如果有）

• EC号（如果有）

• REACH注册号（如果有）（注册物质 以“01”开头，预注册物质以“05”开 头）

• CLP第18条（产品标识）规定的危险物质（每年少于1吨）检索号或CLP参考号

• 每年进口至欧洲经济区或在欧洲经济区使 用的物质数量(kg)

• 供应商名称和地址（各供应商的负责人）

• 物质是由你进口的吗？ 汽车行业REACH指南（AIG）—第4.0版41

• 物质是否被确定为高关注度物质？如果是，物质是否以及在候选清单中或是否具有授权号？

• 物质对你的业务至关重要吗？

• Depending on your role under REACH, you need to collect the following key information in order to determine your REACH obligations (if any):

• Substance/mixture name (supplier’s proprietary name, if any)

• Chemical name

• CAS number (if any)

• EC number (if any)

• REACH registration number if available (starting with “01” for registered substances or “05” for pre-registered substances)

• INDEX number or CLP Reference number for dangerous substances (also < 1 tpa) according to Art. 18 CLP (product identifier)

Amount of substances imported into or used in the EEA per year (kg)

• Supplier name and address (responsible individual for each supplier)

• Is it imported by you?

• Is the substance identified as of very high concern? If yes, is it already on the CL or does it already have an authorisation number?

• Is the substance critical for your business?

其他可能需要添加到物质清单中的信息包括：

• 你是否就你的物质用途的注册与供应商进行了联系？

• 是否存在关于具体用途的机密问题？

• 物质是否已预注册/注册？

• 物质/配制品还可继续可供采购吗？

• 物质是否被列在候选清单、附录XIV（授 全清单）或附录XVII （限制清单）中？

• 物质（如果将来可能禁用）有替代品吗？

• 如果你需要生成用于注册及/或通报CLP清单的数据包，需要什么数据？

• Possible further information you may add to your substance inventory is:

• Have you contacted the supplier about registration for your use?

• Is there a confidentiality issue regarding specific uses?

• Is the substance already pre-registered/registered?

• Will the substance/mixture continue to be available for purchase?

• Is the substance on the CL, on Annex XIV (Authorisation List) or on Annex XVII (Restriction List)?

• Can the substance be substituted (if it is likely to be withdrawn in future)?

• If you need to produce a data package for registration and/or notification to the CLP Inventory, what data is necessary?

• Who else supplies the substance or mixture?

• 还有谁供应此种物质或配制品？ 补充信息： 请注意，根据公司承担的角色不同，需要收集的信息的详细程度也不同。以下矩阵图为角色及各角色所需的信息一览表。 根据不同角色，推荐的清单数据：

Additional considerations: Please note that the level of detail of the information to be collected may vary, depending on the different roles that a company may play. The matrix below gives an overview of these roles and the necessary information for each. Recommended data for inventories, depending on the different roles:

欧盟ROHS2.0指令ROHS检测十项管控物质清单

欧盟ROHS2.0新修订指令(EU)2015/863以及（ROHS2.0指令EU2017/2102）的实施。

关于欧盟ROHS2.0新修订指令(EU)2015/863和ROHS2.0指令EU2017/2102：

根据2015年6月4日欧盟在其官方公报上发布的ROHS2.0指令(EU)2015/863，对限用物质清单进行了修订，增加了四种邻苯二甲S酯，正式将DEHP、BBP、DBP、DIBP列入附录II限制物质清单中，欧盟ROHS2.0(EU)2017/2102为欧盟于2017年11月21日发布的RoHS 2.0附录III的新修订指令;至此附录II共有十项强制管控物质。详见下表：

限制物质清单限量（质量分数）

铅（Pb）0.1%

汞（Hg）0.1%

镉（Cd）0.01%

六价铬（Cr VI）0.1%

多溴联苯（PBB）0.1%

多溴联苯醚（PBDE）0.1%

邻苯二甲S二（2-乙基己基）酯（DEHP）0.1%

邻苯二甲S甲B基丁酯（BBP）0.1%

邻苯二甲S二丁基酯（DBP）0.1%

邻苯二甲S二异丁酯（DIBP）0.1%

此修订指令发布后，欧盟各成员国需在2016年12月31日前将此指令转为各国的法规并执行。且2019年7月22日起所有输欧电子电器产品(除医疗和监控设备)均需满足该限制要求;2021年7月22日起，医疗设备(包括体外医疗设备)和监控设备(包括工业监控设备)也将纳入该管控范围。此外，已属REACH附件XVII第51条邻苯管控的玩具产品将不受此指令中DEHP、BBP、DBP的管控。