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我的主要注册人不再活跃,因为它停止了生产、公司倒闭了或注册被撤销了。我该怎么办?
问题(中文)
我的主要注册人不再活跃,因为它停止了生产、公司倒闭了或注册被撤销了。我该怎么办?
Question (EN)
My lead registrant is no longer active, because it ceased manufacture, the company was closed, or its registration was revoked. What should I do?
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)
您应该尽快与该物质的其他注册人一起指定一位新的牵头注册人。当然,您可以主动提出成为牵头注册人。根据 REACH 法规第 11 条,牵头注册人是法定要求。此外,还有一些重要的实际原因促使您指定一位牵头注册人。因此,确保您的注册有一位牵头注册人对您自身有利。例如,需要一位牵头注册人来让潜在注册人访问联合提交的文件,并确认他们可以参考牵头档案中的信息。牵头注册人也是数据共享谈判的自然第一联络点,从而有助于所有注册人履行其数据共享义务。此外,还需要一位牵头注册人来更新联合提交的物质信息。如果没有牵头注册人,每个注册人都必须单独更新其注册,提供有关该物质的新信息。主注册人消失后,其余注册人需要相互协商,尽快指定新的主注册人。一旦您就新的主注册人达成一致,您应该通过联系表格联系欧洲化学品管理局 (ECHA),并申请移交主注册人角色。如果您知道某种物质的主注册人即将消失,建议您和其他注册人在主注册人消失前指定一位新的主注册人。这样可以确保不会出现主注册人缺失的情况。这在实践中更容易做到,因为原主注册人可以在 REACH-IT 框架内移交主注册人角色。问答 0380 逐步解释了如何操作。
Answer (EN)
You should appoint a new lead registrant together with the other registrants of the substance as soon as possible. Of course, you can offer to become the lead registrant.
A lead registrant is a legal requirement under Article 11 REACH. Moreover, there are important practical reasons why you should have a lead registrant. As such, you have an own interest in ensuring that there is a lead registrant to your registration.
For example, a lead registrant is needed to give potential registrants access to the joint submission and to confirm that they may refer to the information in the lead dossier. A lead registrant is also a natural first contact point for data sharing negotiations, and thus facilitates all registrants’ compliance with their data sharing obligations. In addition, a lead registrant is needed to update the information that was jointly submitted for a substance. Without a lead registrant, each registrant must update its registration individually with new information about the substance.
After the lead registrant has disappeared, the remaining registrants need to discuss among each other to appoint a new lead registrant as soon as possible. Once you have agreed on a new lead registrant, you should contact ECHA via the contact form, and request the transfer of the lead registrant role.
If you know that your lead registrant for a substance will disappear, you and the other registrants are encouraged to appoint a new lead registrant before the disappearance. Like that you ensure that there is no time without a lead registrant. This is easier to do in practice, because the old lead registrant can hand over the lead registrant role within REACH-IT. Q&A 0380 explains what to do step-by-step.