如果在物质注册时添加一个或多个纳米形态，会对已经注册的一组纳米形态产生什么影响？

如果在物质注册时添加一个或多个纳米形态，会对已经注册的一组纳米形态产生什么影响？

What is the impact for an already registered set of nanoforms if one or several nanoforms are added in the registration of the substance?

如果要更新注册以涵盖其他纳米形态，则需要决定是否将这些纳米形态 (i) 单独注册为单独的纳米形态；(ii) 注册为一组新的纳米形态；或 (iii) 通过修改已注册的纳米形态组进行注册。如果将纳米形态作为单独的纳米形态或一组新的纳米形态添加到注册中，则不会影响已注册的纳米形态组。与现有集合类似，需要通过在档案中包含该集合的适当特性、集合依据以及与该集合对应的附件 VII-X 信息来进行注册。如果将纳米形态添加到现有纳米形态集合的注册中，则需要确保这些纳米形态符合现有集合明确定义的特性边界。如果不是，则需要分析是否可以扩展集合的边界，而不会影响集合涵盖的所有纳米形态的联合危害评估、暴露评估和风险评估。该分析必须反映在所提供的集合论证中。

If the registration will be updated to cover additional nanoforms, the decision needs to be made whether the nanoforms will be registered (i) on their own as separate nanoforms; (ii) as a new set of nanoforms; or (iii) by modifying the already registered set of nanoforms.  If the nanoforms are added to the registration as separate nanoforms or as a new set of nanoforms, they will not impact the already registered set of nanoforms. Similarly as for the existing set, they need to be registered by including in the dossier the appropriate characterisation of the set, the set justification and the Annex VII-X information corresponding to the set. If the nanoforms are added to the registration in an existing set of nanoforms, you need to ensure that the nanoforms fit within the clearly defined boundaries of characterisers of the existing set. If this is not the case, you need to analyse whether the boundaries of the set can be expanded without affecting the joint hazard assessment, exposure assessment and risk assessment of all the nanoforms covered by the set. This analysis must be reflected in the provided justification for the set.