注册人是否需要对一组纳米形态中的每个纳米形态进行表征和报告，或者分组的理由是否充分？

注册人是否需要对一组纳米形态中的每个纳米形态进行表征和报告，或者分组的理由是否充分？

Do registrants need to characterise and report each nanoform within a set of nanoforms, or is the justification for grouping sufficient?

为了能够构建纳米形态集合，您可能需要对单个纳米形态进行表征，以便将它们分配到合适的集合中，并提供充分的论证。如果纳米形态包含在一个纳米形态集合中，则无需在 IUCLID 档案中报告该集合中所有纳米形态的表征信息。相反，当通过一组相似的纳米形态注册纳米形态时，您必须清晰地报告每个表征器在该集合中的边界，并为每个表征器提供该集合的论证。

To be able to build the set(s) of nanoforms, you may need to characterise the individual nanoforms in order to allocate them in the appropriate set and provide an adequate justification. If nanoforms are included in a set of nanoforms, you are not expected to report information on the characterisation of all the nanoforms in the set in the IUCLID dossier. Instead, when registering nanoforms via a set of similar nanoforms, you must clearly report the boundaries of the set for each of the characterisers and provide a justification for the set, per characteriser.