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即使其表征参数没有改变,生产线的改变是否需要更新我们关于所报告纳米形态的注册档案?
问题(中文)
即使其表征参数没有改变,生产线的改变是否需要更新我们关于所报告纳米形态的注册档案?
Question (EN)
Would a change of a production line trigger a need to update our registration dossier regarding the reported nanoform , even if its characterisation parameters are not changed?
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)
如果现有注册档案中报告的纳米形态/纳米形态集合的表征参数均未发生变化,则无需更新档案中涵盖的纳米形态的标识。需要注意的是,即使所有数值表征参数均未发生变化,如果生产线的变更涉及表面处理工艺,注册档案中关于表面处理工艺的描述仍可能需要更新。
Answer (EN)
If none of the characterisation parameters of the nanoform(s)/set(s) of nanoforms reported in the existing registration dossier change, there is no need to update the dossier with regard to the identity of the nanoforms covered.
Note that even if none of the numerical characterisation parameters change, if the change in the production line concerns the surface-treatment process, the description of the surface-treatment process in the registration dossier may still need to be updated.