调查档案中包含的分析数据是否必须针对制造或进口的物质生成？

调查档案中包含的分析数据是否必须针对制造或进口的物质生成？

Does the analytical data included in an inquiry dossier have to be generated on the manufactured or imported substance?

原则上，询价或注册档案中包含的分析数据必须反映所生产或进口的物质。因此，如果您是欧盟制造商，则必须提交由您生产的样品生成的分析数据。如果您从欧盟以外进口，则必须提交由非欧盟制造商生产的样品生成的分析数据。我们知道，如果您必须在开始生产或进口之前注册您的物质，这可能会带来问题。在这种情况下，我们可能接受从其他来源提交分析数据。对于这些特殊情况，您需要在询价档案中解释以下问题：为什么无法生成所生产物质的分析数据。为什么您打算生产或进口的物质与用于生成分析数据的物质相同。例如，声明用于生产所分析物质的制造工艺和/或工厂规格将与询价物质的规格相同。您还需要在询价档案中提供以下信息：所分析物质的来源，即生产地点名称和地址。询价物质和分析物质的生产工艺及原材料的简要描述。询价物质的预计生产量或进口量。分析数据所有者的声明，表明您已获得其使用分析数据的许可。您需要在提交注册卷宗后6个月内更新物质标识信息，以反映该物质已生产或进口。如果未更新注册信息，ECHA可能会启动针对物质身份的合规性检查。

In principle, the analytical data included in an inquiry or a registration dossier must reflect the substance as manufactured or imported. Hence, if you are an EU manufacturer, you must submit analytical data generated from a sample that you have manufactured. If you import from outside the EU, you must submit analytical data generated from a sample manufactured by the non-EU manufacturer. We are aware that this can be problematic if you have to register your substance before taking up manufacture or import. For such cases we may accept submitting analytical data from another source. For these exceptional cases, you need to explain the following in your inquiry dossier: Why the analytical data cannot be generated on the manufactured substance. Why the substance you intend to manufacture or import will be the same as the one used to generate the analytical data. For example, a statement that the manufacturing process and/or plant specification used to produce the analysed substance will mirror that for the inquired substance. You also need to provide the following information in your inquiry dossier: The source of the analysed substance i.e. manufacturing site name and address. A short description of the production process and the raw materials for both the inquired substance and the analysed substance. The foreseen manufacturing or import volume for the inquired substance. A statement from the owner of the analytical data indicating that you have their permission to use their analytical data You are required to update the substance identification information in the registration dossier within 6 months after the submission to reflect the substance as manufactured or imported. If the registration is not updated, ECHA may initiate a targeted compliance check on substance identity.