中文内容由 Google Cloud Translation 自动生成，仅供参考；请以英文原文为准。问答资料来自欧盟化学品管理局（ECHA）官方网站。
答案（中文）
作为下游用户，您将收到一份附有暴露场景的安全数据表 (SDS)，该数据表针对注册量超过 10 吨/年的危险物质（包括纳米形态）。如果您的供应商涵盖了纳米形态的用途（包括相关的纳米形态的创建及其后续用途），则 SDS 将在第 1.2 节中注明这些用途，并随附描述该用途条件的相关暴露场景。供应商的安全数据表还必须包含纳米形态的特性信息。规定 SDS 内容的 REACH 附件 II 最近已更新。在 2022 年 12 月 31 日之前，您可以继续按照 (EU) 2015/830 法规提供 SDS，也可以按照 (EU) 2020/878 法规以新格式提供 SDS。如果供应商的 SDS 是根据 (EU) 2020/878 法规编制的，那么纳米形态的特征信息将在第 3 节（物质为 3.1，混合物为 3.2）或第 9 节中找到。如果 SDS 是根据 (EU) 2015/830 法规编制的，则供应商可以将信息包含在第 9 节的“(a) 外观”小节下，其中应包含有关“粒度”的信息。有关 SDS 供应商义务的更多详细信息，请参阅安全数据表编制指南。如果您作为下游用户创建纳米形态，并且您从供应商处收到的 SDS 包含有关尺寸、形状、表面处理和比表面积 (SSA) 方面的特征信息，则必须将其与您生成的纳米形态的信息进行比较，并确定您的纳米形态是否在供应商的 SDS 的涵盖范围内。 《注册和物质识别指南的纳米形态附录》指南提供了有关如何区分不同纳米形态的详细信息。实际上，您在 SDS 中收到的信息可能指的是单个纳米形态，其中包含四个特征（尺寸、形状、表面处理和 SSA）中每个特征的数据（请参阅安全数据表编制指南第 50 页表 1 中可能的格式示例）。在这种情况下，您可以查阅 ECHA 指南《注册和物质识别指南的纳米形态附录》第 4 节，特别是专门针对每个纳米形态表征参数的“纳米形态集边界原则”小节，以决定您的纳米形态是否在指南中概述的相同原则的涵盖范围内。如果供应商的安全数据表 (SDS) 引用的是一组纳米形态，则应在其 SDS 中指定每个参数所涵盖的边界，并允许您决定所创建的纳米形态是否在涵盖范围内。在这种情况下，您的纳米形态的所有表征参数都必须在 SDS 中设定的边界范围内，以确保其在涵盖范围内。
Answer (EN)
As a downstream user, you receive an SDS with exposure scenarios attached for a hazardous substance (including nanoforms) registered above 10 tonnes/year. If your supplier is covering the uses of your nanoform (including where relevant the creation of a nanoform and its subsequent uses), then the SDS will indicate these uses in Section 1.2 and will include the associated exposure scenario(s) annexed that describe the conditions of that use. The supplier’s SDS must also include the nanoform characterisation information.
REACH Annex II, which prescribes the contents of an SDS has recently been updated. Until 31 December 2022, an SDS may continue to be provided in accordance with Regulation (EU) 2015/830 or can be provided in the new format, according to Regulation (EU) 2020/878. If the supplier’s SDS has been compiled in accordance with Regulation (EU) 2020/878, then the nanoform characterisation information will be found in Section 3 (3.1 for substances, 3.2 for mixtures) or Section 9. If the SDS has been compiled in accordance with Regulation (EU) 2015/830, the supplier can include the information in Section 9 under the subsection ‘(a) Appearance’, where information on “granulometry” should be included. For further details on obligations of SDS suppliers, please see the Guidance on the compilation of safety data sheets.
If you create a nanoform as a downstream user, and the SDS you have received from your supplier contains characterisation information in terms of size, shape, surface treatment and specific surface area (SSA), you must compare it with the information on the nanoform that you have generated and decide whether or not your nanoform is covered by the supplier’s SDS. The Guidance ‘Appendix for nanoforms to the Guidance on Registration and Substance Identification’ provides details on how you can distinguish between different nanoforms. In practice, the information you receive in the SDS may refer to a single nanoform with characterisation data for each of the four characterisers (size, shape, surface treatment and SSA) (see example of possible format in Table 1 on p. 50 of the Guidance on the compilation of safety data sheets). In that case, you can consult section 4 of the ECHA Guidance ‘Appendix for nanoforms to the Guidance on Registration and Substance Identification’, in particular the subsection “Principles on the boundaries of sets of nanoforms” dedicated to each of the nanoform characterisation parameters to make a decision on whether your nanoform is covered by applying the same principles outlined in the guidance.
In the case that the supplier’s SDS refers to a set of nanoforms, the boundaries covered for each of the parameters should be specified in their SDS and allow you to decide whether the nanoform you have created is covered. In such a case, all the characterisation parameters of your nanoform must fall within the boundaries set in the SDS to ensure that it is covered.