Question (EN)
I formulate a mixture by including a nanoform of a substance in it, and REACH requires me to provide a SDS for the mixture. Do I have to report the nanoform in the SDS? If so, what information do I have to provide, and where?
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）
如果需要 SDS 的混合物中包含纳米形态，则仅当混合物中存在纳米形态时，SDS 中有关纳米形态的信息才有意义。如果在包含纳米形态后，混合物中不再存在纳米形态，则也不必在 SDS 中报告该纳米形态。当混合物的成分之一是纳米形态时，必须根据适用于混合物任何其他成分的相同规则在 SDS 中报告，除非适用任何特定于纳米形态的规则。特别应考虑以下章节。第 3 节：如果混合物的某种成分满足 REACH 法规附件 II 第 3.2.1 节（当混合物满足分类标准时）或第 3.2.2 节（当混合物不符合分类标准时）中列出的任何条件，则必须在混合物 SDS 的第 3.2 小节中指明该成分。这也适用于纳米形式的成分。如果纳米形式在 SDS 第 3 部分中指明，并且纳米形式本身已注册或由下游用户化学品安全报告提及，则还必须提供纳米形式的表征参数。有关要包括的特征符列表，请参阅 REACH 法规附件 VI 第 2.4 部分。如果纳米形式既未注册也未由下游用户化学品安全报告提及，则必须提供对混合物安全有影响的特征符。第 9 部分：附件 II 的第 9.1(m) 部分要求指示纳米形式的水溶性，以及在水或其他相关生物或环境介质中的溶解速率。附件 II 的第 9.1(n) 部分澄清正辛醇/水分配系数通常不适用于混合物。在这种情况下，必须注明纳米形态在不同介质中的分散稳定性。附件二第9.1(r)节规定，仅当纳米形态为固体时，才需提供附件六第2.4节中规定的特性参数。如果安全数据表第3节已提供任何这些特性参数，则无需在第9节中重复提供，只需参考第3节即可。与混合物中的任何其他成分一样，当纳米形态存在于提供给接收者的混合物中时，上述要求也适用。即使预计不会接触纳米形态，这些要求也适用。更多详情，请参阅安全数据表编制指南。
Answer (EN)
If a nanoform is included in a mixture for which a SDS is required, the provision of information on the nanoform in the SDS is relevant only if the nanoform is present in the mixture. If, following the inclusion, the nanoform is not present in the mixture anymore, the nanoform will not have to be reported in the SDS either.When one of the ingredients of the mixture is a nanoform, this will have to be reported in the SDS according to the same rules applicable for any other ingredient of the mixture, unless any rule specific to nanoforms applies. In particular, the following sections should be considered.Section 3:If an ingredient of the mixture meets any of the conditions listed in section 3.2.1 of Annex II of the REACH Regulation (when the mixture meets the classification criteria) or section 3.2.2 (when the mixture does not meet the classification criteria), the ingredient will have to be indicated in sub-section 3.2 of the mixture SDS. This also applies to ingredients that are nanoforms.If the nanoform is indicated in section 3 of the SDS, and the nanoform itself is registered or addressed by a downstream user chemical safety report, the characterisation parameters of the nanoform will also have to be provided. For a list of characterisers to be included, see Section 2.4 of Annex VI of the REACH Regulation. If the nanoform is neither registered nor addressed by a downstream user chemical safety report, the characterisers having an impact on the safety of the mixture will have to be provided.Section 9:Section 9.1(m) of Annex II requires the indication of the water solubility of the nanoform, as well as the dissolution rate in water or in other relevant biological or environmental media.Section 9.1(n) of Annex II clarifies that the n-octanol/water partition coefficient does not generally apply to mixtures. In this case, the dispersion stability of the nanoform in different media must be indicated.Section 9.1(r) of Annex II establishes that the characterisation parameters set out in Section 2.4 of Annex VI must only be provided in case of solids. If any of these characterisers are already provided in section 3 of the SDS, they will not have to be replicated in section 9 and a reference to section 3 will be sufficient.Similarly as with any other ingredient of a mixture, the requirements listed above apply when the nanoform is present in the mixture as supplied to the recipient. They apply even if no exposure to the nanoform is expected.For additional details, see the Guidance on the compilation of safety data sheets.