每次从新的非欧盟制造商进口物质时，注册人是否需要使用新的分析数据集更新其注册档案？

每次从新的非欧盟制造商进口物质时，注册人是否需要使用新的分析数据集更新其注册档案？

Is a registrant required to update their registration dossier with a new analysis dataset each time the substance is imported from a new non-EU manufacturer?

没有明确的法律义务要求注册人每次从新的非欧盟来源进口时都更新其注册档案。但是，根据 REACH 法规第 22(1)(b) 条，注册人有义务更新附件 VI 第 2 节中给出的物质成分。根据 ECHA 网站上的物质识别和命名指南，注册人每次从新来源进口物质时都必须评估物质的相同性。此评估有三种可能的结果：1. 注册人发现该物质与以前进口的物质具有相同的杂质概况，并且已经由他们注册。他们不必更新该物质的注册档案。2. 注册人发现该物质与以前进口的物质具有不同的杂质概况。然后，他们必须使用该物质的新成分更新注册档案的相关部分（例如浓度范围或 C&L 的变化）。3.如果注册人发现新物质与其已注册的物质不同，且每年进口量达到或超过一吨，则必须为该新物质提交单独的注册档案。对于第1项和第2项，注册人应持有必要的文件，以便在执法检查中证明其与已注册物质相同。

There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-EU source. However, according to Article 22(1)(b) of REACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances available on the ECHA website.There are three possible outcomes of this assessment: 1. Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance. 2. Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in C&L) with the new composition of the substance.3. Registrants find that the substance is not the same as already registered by them. They then have to submit a separate registration dossier for this new substance, if they import one tonne per year or more of the substance.For 1 and 2, the registrant should possess the necessary documentation to be able to prove during enforcement inspections the sameness with the already registered substance.