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牵头注册人如何降低联合提交文件的吨位范围?
问题(中文)
牵头注册人如何降低联合提交文件的吨位范围?
Question (EN)
How can the lead registrant decrease the Joint Submission’s tonnage band?
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)
步骤 1:在降低联合提交的吨位范围之前,牵头注册人需要确保联合提交的所有成员的吨位范围等于或低于降低后的(新)联合提交的吨位范围。中间注册的吨位范围不会影响完整联合提交的吨位范围,因此,仅具有中间注册的成员的吨位范围可以高于降低后的联合提交。步骤 2:牵头注册人使用与上次成功提交相同的提交类型标准注册或中间注册,但吨位范围降低,提交更新的档案。如果牵头注册人的吨位范围高于新联合提交的吨位范围,则牵头注册人必须更新其自己的注册吨位范围(管理信息),使其等于或低于降低后的吨位范围。将档案标记为更新,添加上次成功提交的编号,并从下拉菜单中选择“联合提交吨位等级变更”作为自发更新的理由。请注意:如果欧洲化学品管理局 (ECHA) 已向联合提交成员发送最终决定,则即使在吨位等级降低后,他们仍需遵守该决定。
Answer (EN)
Step 1Before decreasing the Joint Submission tonnage band, the Lead Registrant needs to make sure that all members of the Joint Submission have the tonnage band equal or below the decreased (new) Joint Submission’s tonnage band.The tonnage band of intermediate registrations do not affect the tonnage band of the full joint submission, therefore, a member with an intermediate only registration can have a higher tonnage band than the decreased Joint Submission.Step 2The Lead Registrant submits an updated dossier using the same submission type standard registration or intermediate registration that was used for the last successful submission, but at a decreased tonnage band.If the Lead Registrant’s tonnage band is above the new Joint Submission’s tonnage band, the Lead Registrant has to update its own registration's tonnage band (administrative information) to be equal or lower than the decreased tonnage band. Mark the dossier as an update, add the last successful submission number and chose ‘change of joint submission tonnage band’ from the drop-down menu as justification for the spontaneous update. Please note: If a final decision from ECHA was sent to the Joint Submission members, they will need to comply with such decision even after the tonnage band decrease.