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答案（中文）
为了创建一组纳米形态，您需要明确定义该组纳米形态的边界，并提供论证，证明该组中纳米形态的危害评估、暴露评估和风险评估可以对组中包括的所有纳米形态联合进行，无一例外。此证明可能需要您测试其中一些纳米形态。事实上，这种论证必须有科学证据支持，这些科学证据需要说明该组纳米形态边界内的纳米形态的物理化学、环境归宿、生态毒性和毒性特性。论证中总结的每个科学证据都应对应一份（稳健的）研究摘要。有关如何论证一组纳米形态的更多信息，请参阅问答 1681。一旦建立了一组纳米形态并进行了科学论证，就必须为该组纳米形态提供完整的附件 VII-X 信息。没有必要为该组中包括的每个纳米形态生成附件 VII-X 属性的数据。事实上，如上所述，对一组纳米形态的论证必须证明，可以对组中所有纳米形态联合进行纳米形态的危害、暴露和风险评估。但是，每项信息要求提供的数据必须代表整组纳米形态。对于附件 VII-X 中的每项信息要求，注册人必须提交 (i) 对相关纳米形态进行的研究；或 (ii) 对物质其他形态的研究，并附上针对终点的具体论证，说明为什么这些信息足以评估相关的纳米形态；或 (iii) REACH 附件 XI 或相关附件 VII-X 第 2 栏预见的相关调整。如 G 章“联合提交”中所述，附件 VII-X 信息可由牵头注册人代表其他同意注册人提交，也可由共同注册人通过选择退出机制单独提交。
Answer (EN)
In order to create a set of nanoforms, you need to clearly define the boundaries of your set of nanoforms, and provide a justification to demonstrate that the hazard assessment, exposure assessment and risk assessment of the nanoforms in the set can be performed jointly for all nanoforms included in the set, without exceptions. This demonstration may require you to test some of these nanoforms. Indeed, this justification must be substantiated by scientific evidence addressing the physicochemical, environmental fate, ecotoxicity and toxicity properties of nanoforms that are within the boundaries of the set of nanoforms. Each scientific evidence summarised in the justification should correspond to a (robust) study summary. For further information on how to justify a set of nanoforms, refer to Q&A 1681.
Once a set of nanoforms has been established and scientifically justified, the complete Annex VII-X information must be provided for the set of nanoforms. It is not necessary to generate data on the Annex VII-X properties for each nanoform included in the set. Indeed, as mentioned above, the justification for the set of nanoform must prove that the hazard, exposure and risk assessments of the nanoforms can be performed jointly for all nanoforms in the set. However, the data provided for each information requirement must be representative for the whole set of nanoforms.
For every information requirement as per Annex VII-X, the registrant must submit either (i) studies performed on the nanoforms concerned; or (ii) studies on other forms of the substance accompanied by endpoint-specific justifications as to why this information is adequate for assessing the nanoforms concerned; or (iii) relevant adaptations as foreseen by Annex XI of REACH or Column 2 of the relevant Annex VII-X.
As explained in chapter G. Joint submission, the Annex VII-X information can be submitted by the lead registrant on behalf of the other assenting registrants, or separately by co-registrants via the opt-out mechanism.