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)
如果您(作为申请人)已经注册了附件 XIV 物质,则为注册目的而准备的 CSR 应作为授权申请所需 CSR 编制的基础。但是,它可能需要更新并根据授权情况进行调整(例如,关于用途、排放和暴露的细化,以及 CSR 的整体质量等)。提交申请时,您可以附上专为授权而开发的 CSR 版本。如果您可能希望仅出于授权目的提供注册过程中提交的最新更新 CSR 的摘录,则可以利用此机会。此更新的 CSR 将仅包含与授权申请相关的部分,但会更加详细。或者,您可以直接参考注册档案中提供的 CSR。在后一种情况下,您应该(如有必要)在向 ECHA 提交申请之前更新您的 CSR。如果您制定了特定的 CSR 以供授权,则应注意,授权申请中提交的 CSR 中包含的信息通常应包含在注册档案中提供的 CSR 中。在日落日期之后,申请人需要更新注册中提交的 CSR,以删除所有未申请授权的用途。在委员会做出授权决定后,申请人可能还需要进一步更新其注册中提交的 CSR。
Answer (EN)
If you (as the applicant) have already registered the Annex XIV substance, the CSR prepared for registration purposes should be the basis for the preparation of the CSR needed in an application for authorisation. However, it is likely that it needs to be updated and adapted to the authorisation context (e.g. regarding the refinement of uses, emissions and exposures, the overall quality of the CSR, etc). When submitting your application you can attach a version of your CSR specifically developed for authorisation. You can use this opportunity in cases, where you may wish to provide – for the authorisation purposes – only an extract of the latest updated CSR submitted in the registration process. This updated CSR would contain only those parts that are relevant for the authorisation application, but developed in more detail.
Or you can simply refer to the CSR provided in your registration dossier. In the latter case you should – if necessary – update your CSR before you submit your application to ECHA. If you develop a specific CSR for authorisation, you should be aware that as a rule the information contained in the CSR submitted in an authorisation application should be in the CSR provided in the registration dossier.
After the sunset date the applicant will need to update the CSR submitted in the registration in order to remove all uses for which he has not applied for authorisation.
Following the authorisation decision taken by the Commission, the Applicant may also need to further update the CSR submitted in his registration.