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）
一组纳米形态必须基于一项论证，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联合进行。该论证必须普遍适用于所有适用的信息要求，包括新的纳米形态特定终点，如附件 VII 第 7.14 之二“尘埃性”。该论证必须始终提供支持性数据。更具体地说，该论证必须满足以下条件：该论证必须分别针对附件 VI 第 2.4 节中列出的每个特征。为此，它必须遵循 IUCLID 第 1.2 节“报告一组类似纳米形态的理由”字段中提供的文本模板结构，并解决其中的所有适用点。该论证必须通过科学证据证实，该科学证据涉及纳米形态集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。对于每个特征，论证必须总结支持数据。论证中总结的每一项科学证据都必须以（稳健）研究摘要的形式提交。在所有上述情况下，这些研究的结果和研究中使用的纳米形态的特征都必须根据所列要点进行总结。（稳健）研究摘要可以通过将其附加到第 1.2 节“附加信息”字段中来提供；当（稳健）研究摘要在 IUCLID 档案的其他地方报告时，例如在 IUCLID 第 4-7 节中，也可以通过第 1.2 节“交叉引用”字段进行链接来引用它；或者，可以提供对公开文献的引用，而不是稳健研究摘要。对于每个特征，论证必须解释科学证据如何证明该集合中的所有纳米形态可以联合评估。该解释必须清楚地表明，用于生成支持数据的纳米形态代表了集合边界内包含的所有纳米形态。必须在“类似纳米形态集报告理由”或“附加信息”字段中完整提供理由。理由不能引用档案中其他地方提供的解释。在完整性检查期间，ECHA 工作人员会针对描述一组纳米形态的每个边界成分，手动验证“类似纳米形态集报告理由”和“附加信息”字段中提供的理由。有关如何报告一组纳米形态理由的更多信息，请参阅以下支持材料：如何准备涵盖纳米形态的注册档案 完整性检查时手动验证的信息
Answer (EN)
A set of nanoforms must be based on a justification demonstrating that the hazard assessment, exposure assessment and risk assessment of the nanoforms in the set can be performed jointly. The justification must apply generically to all the applicable information requirements, including the new nanoform-specific endpoints like Annex VII point 7.14 bis Dustiness. The justification must always be substantiated by supporting data.
More specifically, the justification must fulfil the conditions below:
The justification must address separately each characteriser listed in section 2.4 of Annex VI. To this end, it must follow the structure of the text template available in the IUCLID section 1.2 field 'Justification for reporting set of similar nanoforms' and address all applicable points in it.
The 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. For each characteriser, the justification must summarise the supporting data.
Each scientific evidence summarised in the justification must be submitted in the form of a (robust) study summary
In all the above cases, the findings from these studies and the characterisers of the nanoforms used in the studies must be summarised in accordance with the points listed.
The (robust) study summary can be provided by attaching it in the section 1.2 field ‘Attached information’;
When the (robust) study summary is reported elsewhere in the IUCLID dossier, e.g. in IUCLID section 4-7, a reference to it can also be made by linking it via the section 1.2 field ‘Cross-reference’;
Alternatively, references to publicly available literature may be provided instead of a robust study summary.
For each characteriser, the justification must explain how the scientific evidence demonstrates that all the nanoforms in the set can be assessed jointly. This explanation must clearly show that the nanoforms used to generate the supporting data are representative of all the nanoforms included in the boundaries of the set.
The justification must always be provided in full in the field 'Justification for reporting set of similar nanoforms' or in the field ‘Attached information’. The justification cannot refer to explanations provided elsewhere in the dossier.
The justification provided in the field 'Justification for reporting set of similar nanoforms' and ‘Attached information’ is manually verified by ECHA staff during completeness check, for each boundary composition describing a set of nanoforms.
For further information on how to report a justification for a set of nanoforms, please refer to the following support material:
How to prepare registration dossiers covering nanoforms
Information on manual verification at completeness check