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）
每个注册人负责注册他们自己生产或进口的纳米形态。因此，每个注册人都有义务表征他们生产/进口的纳米形态（单独或通过纳米形态组），并确保为每个纳米形态或每组纳米形态提供特定的危险数据集。附件 VI 所要求的信息，包括纳米形态的特征，必须始终由每个注册人在其 IUCLID 档案中单独提交。每个共同注册人负责识别他们自己的纳米形态。然后，由联合提交的共同注册人决定是否联合或单独提交有关物质纳米形态的危险数据（即附件 VII 至 X 的信息要求）。通过免除提供每个纳米形态危害数据的义务，共同注册人可以识别具有明确边界的纳米形态集，前提是他们可以证明可以对集合中包含的纳米形态联合进行危害、暴露和风险评估。在这种情况下，可以为集合中的所有纳米形态提交一组危害数据。因此，首先，注册人必须决定如何涵盖他们制造或进口的纳米形态，是作为单个纳米形态还是一组纳米形态（受上述条件的约束）或两者兼而有之。其次，注册人必须决定他们的纳米形态是否包含在联合提交的危害信息中。在这种情况下，他们需要就联合提交的数据达成一致。联合提交的数据可以涉及单个纳米形态或纳米形态集。如果信息是联合提交的，共同注册人只需根据附件六识别其纳米形态，但无需提交涵盖其纳米形态的危害数据。相反，共同注册人必须在其注册档案中将其纳米形态与主档案中提交的相应危害数据关联起来。为此，共同注册人必须在第1.2节每个法人实体成分记录的“相关成分参考”字段中引用主档案的边界成分记录。该边界成分必须与共同注册人的纳米形态或纳米形态组相关，并且必须与提交的附件七至十信息相关联，以满足其信息要求。请注意，如果共同提交的信息涉及一组纳米形态，则共同注册人必须确保其自身的纳米形态符合主要档案中一组纳米形态边界成分所报告的特征，并且为同一边界成分的纳米形态组提供的论证涵盖其纳米形态。如果共同注册人单独提交信息，则必须确保通过选择退出的方式为其纳米形态提供特定的危害数据集，如 REACH 法规第 11(3) 条所规定。在第二种情况下，共同注册人必须提交 IUCLID 第 4-7 节中要求的其纳米形态的所有危害数据。
Answer (EN)
Each registrant is responsible for registering the nanoforms that they themselves manufacture or import. Therefore, each registrant has the obligation to characterise the nanoforms (either individually or through sets of nanoforms) they manufacture/import and to ensure that a specific hazard data set is provided for each nanoform or set of nanoforms.
The information required by Annex VI, including the characterisation of nanoforms, must always be submitted separately by each registrant in their IUCLID dossier.
It is up to each co-registrant to identify their own nanoform(s). It is then up to the co-registrants in the joint submission to decide whether to submit the hazard data (i.e. information requirements of Annexes VII to X) on the nanoforms of the substance jointly or separately.
By derogation to the obligation to provide hazard data on each single nanoform, co-registrants can identify sets of nanoforms with clearly defined boundaries if they can justify that the hazard, exposure and risk assessments can be performed jointly for the nanoforms included in the set. In this case, one set of hazard data can be submitted for all nanoforms within the set.
Therefore, first, registrants must decide how they want to cover the nanoforms they manufacture or import, either as single nanoforms or in a set of nanoforms (subject to the conditions described above) or both.
Second, registrants must decide whether their nanoforms will be covered by the hazard information jointly submitted. In that case, they need to agree on the data to be jointly submitted. The data jointly submitted can concern single nanoforms or set(s) of nanoforms.
If the information is jointly submitted, the co-registrant only has to identify his nanoform(s) under Annex VI, but he does not have to submit himself the hazard data that cover his nanoform(s). Instead, the co-registrant must link in his registration dossier his nanoform(s) to the corresponding hazard data submitted in the lead dossier. To this end, the co-registrant must refer to a boundary composition record of the lead dossier in the field ‘Reference to related composition(s)’ of each section 1.2 legal entity composition record. This boundary composition must be relevant to the co-registrant’s nanoform or set of nanoforms, and must be linked to the Annex VII-X information submitted to cover the information requirements for it.
Note that if the jointly submitted information concerns a set of nanoforms, the co-registrant must ensure that his own nanoform(s) fall within the characterisers reported for a boundary composition for a set of nanoforms in the lead dossier, and that the justification provided for the set of nanoforms in this same boundary composition covers his nanoforms.
If the information is submitted separately by the co-registrant, he must ensure that a specific hazard data set is provided for his nanoform(s) via an opt-out, as foreseen in Article 11(3) of REACH. In this second case, the co-registrant must submit all the hazard data required for his nanoforms in sections 4-7 of IUCLID.