当纳米形式的颗粒在微米尺寸范围内聚集时，我们是否需要表征聚集体和/或组成颗粒？

当纳米形式的颗粒在微米尺寸范围内聚集时，我们是否需要表征聚集体和/或组成颗粒？

When particles of a nanoform form agglomerates in micrometre size range, do we need to characterise agglomerates and/or constituent particles?

REACH 附件 VI 中的要求是报告基于数量的粒度分布，并指明尺寸范围在 1-100 纳米内的组成颗粒的数量分数。即使您制造/进口的纳米形式的组成颗粒形成团聚体，情况也是如此。每个注册人在 IUCLID 的第 1.2 和 1.4 节中报告此信息。有关团聚体尺寸的信息应在 IUCLID 第 4.5 节“粒度分布（粒度测定）”中报告。第 4.5 节中的信息通常由牵头注册人代表共同注册人联合提交。但是，成员注册人可以通过选择退出的方式提交，特别是如果提交的信息是他特有的并且被视为机密时。

The requirement in REACH Annex VI is to report the number-based particle size distribution with indication of the number fraction of constituent particles in the size range within 1-100 nm. This is the case even if the constituent particles of the nanoform you manufacture/import form agglomerates. This information is reported by each registrant in sections 1.2 and 1.4 of IUCLID . Information on the size of the agglomerates shall be reported in IUCLID section 4.5 “Particle size distribution (Granulometry)”. The information in section 4.5 is normally submitted jointly by the lead registrant on behalf of the co-registrants. Nevertheless, it can be submitted by a member registrant via the opt-out approach, especially if the information submitted is specific to him and considered confidential.