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REACH绿色合规----物质/配制品/物品的进口
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-25 | 203 次浏览 | 分享到:

REACH中的进口是指“实际引入欧盟关税区域内”(REACH第3.10条)。进口商进一步定义为“在欧盟内负责进口业务的自然人或设立的法人”(REACH第3.11条)。自欧洲经济区以外进口的单独物质、配制品中的物质及物品中的物质需要承担不同的REACH义务 (注册、通报、信息传递、授权),这些义务规定与欧洲经济区内制造/供应的物质相同。 如:进口物品的有意释放物质需要进行注册, 其规定与在欧洲经济区生产的物品的有意释放物质相同(参见第5.8节)。进口单独物质、 配制品中的物质或物品中的物质可根据以下规定执行REACH程序: 

Import under REACH means “the physical introduction into the customs territory of the Community” (Art. 3.10  REACH). The importer is further defined as any natural  or legal person established within the Community  who is responsible for the import” (Art. 3.11 REACH).  Substances on their own, in mixtures and in articles  that are imported from outside the EEA underlay  different obligations under REACH (registration,notification,communication,authorisation), following the same rules as if manufactured/supplied in the EEA. E.g. registration is required for substances intended  to be released from an imported article, following the same regime as substances intended to be released  from an article produced in the EEA (see Chapter 5.8).  REACH procedures for an imported substance on its  own, in mixtures or in articles may be carried out by:


“非欧洲经济区制造商的唯一代表”: 

REACH第8.1条规定制造单独物质、配制品或物品中的物质、配制配制品或生产物品并将其进口至欧洲经济区的在欧盟境外自然人或法人,可根据双方协议,指定一名在欧盟内自然人或法人,作为唯一代表履行进口商的义务。 

The“OR of a non-Community manufacturer”: 

Art. 8.1 REACH foresees that a natural or legal person established outside the Community who manufactures a substance on its own, in mixtures or in articles,  formulates a mixture or produces an article that  is imported into the Community may by mutual agreement appoint a natural or legal person established  in the Community as an OR to fulfil all the obligations of  the importer.


指定唯一代表后,相同供应链中的欧洲经济区进口商都可被视为下游用户,无论其是否与非欧洲经济区供应公司有关联,无需遵循相应的REACH要求。非欧洲经济区制造商的唯一 代表具有履行REACH所有相关义务的法律责 任,且必须设在欧洲经济区境内(REACH第 8.2条)。 

If an OR is appointed, the EEA importers of the same  supply chain, whether they are affiliated to the non-EEA  supplying company or not, are regarded as DUs and do not need to carry out the affected REACH requirements. The OR of the non-community manufacturer has  the legal responsibility to comply with all relevant  obligations under REACH and must be based in the EEA  (Art. 8.2 REACH).


如果未在欧洲经济区指定唯一代表,向欧洲经 济区市场进口物质、配制品或物品的公司(适用于其所有的进口股份制或注册法人实体)将被视为进口商,应履行REACH所有的相关义务,无论其是否: 

In the absence of an OR appointed in the EEA, companies (for each of their importing legally incorporated  or registered entities) importing the substance or  mixtures or article into the Community market are  regarded as importers and are responsible for carrying  out all REACH relevant obligations whether they:


• 进口单独物质(包含在附录XIV中) (REACH第56条规定的授权义务)。参见 第5.11节。 

• 进口含有0.1%w/w以上候选清单物质的物 品,并将其供应给欧洲经济区的其他接收方 (REACH第33条规定的信息传递义务)。 参见第5.10节。 

• 进口含有0.1%w/w以上候选清单物质的物品,且每个进口商每年该物质的进口量超过 1吨(REACH第7条规定的通报要求)。参见第5.9节。 

• 进口有意释放物质的物品,且每个进口商每年进口物品中的物质数量达到或超过1吨 (REACH第7.1条规定的注册义务)。另见 第5.8节。 

• 向下游接收方提供进口物质或配制品的安全数据表/扩展安全数据表。安全数据表的草拟是制造商或进口商的职责,制造商或进口商应在合理可行的范围内预计物质或配制品可能的用途。供应链中的下游行为人也应提供数据安全表,利用其供应商提供的信息, 检查这些信息的合理性并对其进行补充,以满足客户的具体需要。在任何情况下,需要提供安全数据表/扩展安全数据表的物质或配制品供应商都应对其内容负责,即使安全数据表/扩展安全数据表不是由他们自己编制也要负责。参见第5.6.2节。

•Import a substance (included in Annex XIV) on its own (authorisation obligation according to Art. 56  REACH). See Chapter 5.11. 

• Import articles with CL substances included above 0.1% w/w, to be supplied to the next recipient in the EEA (communication according to Art. 33 REACH).  See Chapter 5.10.

• Import articles with CL Substances included above  0.1% w/w and exceeding 1 tonne per year per importer (notification requirement according to Art. 7  REACH). See Chapter 5.9. 

• Import an article intentionally releasing a substance  and the substance is present in articles in quantities  of 1 tonne or above per year per importer (registration obligation according to Art. 7.1 REACH). See also  Chapter 5.8.  

• Provide SDSs/Ext-SDSs of imported substances or  mixtures to their next recipient. The initial responsibility for drawing up the safety data sheet falls to the  manufacturer or importer, who should anticipate, so  far as it is reasonably practicable, the uses to which  the substance or mixture may be put. Actors further  down the supply chain should also provide a safety  data sheet, drawing on, checking the adequacy of  and adding to, the information provided by their suppliers to cater for the specific needs of their customers. In all cases, suppliers of a substance or a mixture  that requires an SDS/Ext-SDS have the responsibility  for its contents, even though they may not have prepared the SDS/Ext-SDS themselves. See Chapter 5.6.2


注» 欧洲经济区成员国之间的物质/ 配制品及物品供应不属于进口。 

» 如果一家跨国公司在欧洲经济区以外制造单独物质、配制品中物质或有意释放物质的物品中物质,并通过自己的欧洲分公司向欧洲经济区进口,则后者属于进口商。各法人实体(即跨国公司的国内商业性组织或各物品分销中心)自母公司或任何位于欧洲经济区以外的其他公司进口物质必须对物质进行注册,并加入相关的物质信息交换论坛(SIEF)。多家注册者可以联合提交数据(REACH第11条)。 大部分数据的联合提交需遵循“一种物质,一次注册“(OSOR)的原则。 

» “自欧洲经济区以外的不同国家的不同供应商进口同一物质时,欧洲经济区进口商无需针对每家供应商进行重复注册。进口商可根据进口物质进行注册,只要注册物质相同即可。”

NOTE » The supply of substances/mixtures and articles  from EEA Member States to other EEA Member  States are not considered imports.  

» If a globally operating company manufactures a  substance either on its own, in a mixture or in an  article outside the EEA that intentionally releases  substances and then imports it again via its own  European affiliates into the EEA, the latter are the  importers. Each individual legal entity (that is a  commercial country organisation or each distribution centre for finished products of a global company) importing from their parent company or  from any other company located outside the EEA,  has to register the substance and join the related  Substance Information Exchange Forum (SIEF).  Joint submission of data by multiple registrants  is possible (Art. 11 REACH). Joint submission  of most of the data is required by the “One-Substance-One-Registration” (OSOR) principle.  

» When importing an identical substance from different suppliers in different countries outside the  EEA, it is not necessary for the EEA importer to carry out repetitive registrations for each supplier.  The importer may instead register per substance  imported, provided that the substance is identical.


与进口商相反,“出口商”是指向欧洲经济区输送物质、配制品及物品,且不在欧洲经济区内设立的法人实体。 

By contrast to the importer, the“exporter”ships substances, mixtures, and articles into the EEA Community  and is not established in the EEA as a legal entity.


作为出口商,非欧洲经济区公司无需履行 REACH规定的义务。根据合同和其他业务关系,出口商可能需要向进口商或其唯一代表提供物质信息(参见流程图5及后面的补充说明),以帮助他们履行REACH注册义务。另外,汽车供应链中非欧洲经济区供应商会被欧洲经济区的客户要求指定唯一代表,以承担注册的责任。参见后面建议: 

As exporters, non-EEA companies have no formal  obligations under REACH. Based on contracts and other  business relationships, exporters may be required  to provide substance information to the importer or  their OR (see Flowchart 5 and additional text below) to aid in fulfilling the REACH registration obligations.  Alternatively, non-EEA suppliers in the automotive  supply chain may be asked by their EEA customers  to appoint an OR and assume the responsibility for  registration. See recommendation below.


欧洲经济区进口商必须履行REACH注册义务,并加入相关的物质信息交换论坛(SIEF)。 他们需要其供应商提供信息及/或必须通过物质信息交换论坛购买所需的数据。关于进口商的义务,请参见汽车行业REACH指南各章节并总结在流程图6中。

EEA importers must fulfil the REACH registration  obligation and join the related Substance Information  Exchange Forum (SIEF). They will need information provided by their suppliers and/or must purchase the required data through the SIEF. Importer obligations  appear in various sections of this Guideline, and are  summarised in Flowchart 6.



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