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如果主注册人未参与授权申请,我该如何获取其化学品安全报告 (CSR) 数据?如果数据所有者拒绝让我获取其数据,我该怎么办?我可以使用欧洲化学品管理局 (ECHA) 发布网站上的信息吗?
问题(中文)
如果主注册人未参与授权申请,我该如何获取其化学品安全报告 (CSR) 数据?如果数据所有者拒绝让我获取其数据,我该怎么办?我可以使用欧洲化学品管理局 (ECHA) 发布网站上的信息吗?
Question (EN)
How can I have access to the Lead Registrant's Chemical Safety Report (CSR) data if he is not taking part in the application for authorisation? What can I do if the data owner refuses to give me access to its data? Can I use the information available on ECHA's dissemination website?
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)
申请过程中必须提交 CSR。此 CSR 可以是 (i) 申请人自己授权的 CSR,或 (ii) 同一注册申请人提交的 CSR 的参考,或 (iii) 先前申请人的 CSR 的参考(后续授权申请的情况)。如果授权申请人是下游用户(即非注册人),并且他自己生成授权 CSR,则此 CSR 可以基于注册人 CSR 的更新信息,只要他有权使用来自相应数据所有者的信息。但是,REACH 第 30 条规定的数据共享义务不适用于授权。复制或进一步分发在 ECHA 传播网站上发布的注册档案和通知中的 C&L 清单信息可能受版权保护。此外,未经相应信息所有者许可使用这些信息可能会侵犯所有者的权利。本机构对使用该信息可能造成的任何版权或其他侵权行为概不负责。提醒潜在申请人,他们应确保拥有向本机构提交该信息的充分权利,并确认该信息可用于授权申请。另请参阅问题916。
Answer (EN)
A CSR has to be submitted as part of the application. This CSR can be (i) the applicant's own CSR for authorisation, or (ii) a reference to CSR submitted by the same applicant for registration, or (iii) a reference to CSR of a previous applicant (case of subsequent applications for authorisation). If the applicant for authorisation is a Downstream User (i.e. not a registrant) and he generates his own CSR for the authorisation, this CSR can be based on updated information from the registrant's CSR as long as he has the right to use the information from the respective data owners.
However, data sharing obligations as specified under Art 30 of REACH do not apply for authorisation. The reproduction or further distribution of information from Registration Dossiers and Notifications to the C&L Inventory which are published on ECHA's dissemination website may be subject to copyright protection. Furthermore, the use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner. The Agency does not take responsibility for any copyright or other infringements that may be caused by using the information.
Potential applicants are reminded that they shall ensure that they have adequate rights to submit this information to the Agency and acknowledge that this information can be used for the purpose of the application for authorisation.
See also question 916