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)
成员必须向牵头注册人传达其升级吨位的意图。牵头注册人使用与更高吨位(提交类型)相对应的 IUCLID 模板提交档案更新。档案将包含更高吨位所需的所有数据。创建档案时,牵头注册人应在档案标题中注明其自己的吨位,在这种情况下,该吨位将低于所用的模板(管理信息)。牵头注册人成功提交牵头档案后,成员可以提交更新的成员档案,在档案标题(管理信息)中注明新的更高吨位,并支付相应的费用。费用联合提交吨位的增加不产生任何费用,仅对注册吨位的增加收取费用。因此,只要牵头注册人仅增加联合提交的吨位等级,而不增加其自身的注册,他们就不会产生任何额外费用。另一方面,当成员注册人以增加的吨位等级提交更新后的档案时,他们将收到新的发票。联合提交的成员注册人(包括牵头注册人)仅需支付其所需数据的费用和适用的管理费用。如果只有一名成员注册人需要额外的研究,则该成员注册人需要独自支付该数据的费用。如果之后另一个注册人需要新的、更高的吨位等级,则需要由需要这些数据/研究的注册人分摊已执行数据/研究的费用。退出 如果较高吨位所需的数据仅供希望更新其档案的特定成员注册人使用,则他们可以决定不与牵头注册人共享,而是将其包含在自己的档案中,并提交较高吨位的退出申请。提交退出档案后,您将无权享受降低的联合提交费用。此外,任何希望将其注册更新到这一较高吨位的注册人都必须单独将数据包含在其档案中。因此,ECHA 建议牵头注册人的档案包含所有信息,无论其吨位如何。或者,并且只有在大多数共同注册人支持的情况下,成员注册人才能接管联合提交的牵头角色。
Answer (EN)
The member has to communicate their intention to upgrade their tonnage band to the lead registrant.
The lead registrant submits a dossier update using the IUCLID template corresponding to the higher tonnage band (submission type). The dossier will include all data required for the higher tonnage band. When creating the dossier, in the dossier header, the lead registrant should indicate their own tonnage band, which will in this case be lower than the used template (administrative information).
Once the lead has successfully submitted the lead dossier, the member can submit their updated member dossier indicating the new, higher tonnage band in the dossier header (administrative information) and pay the corresponding fee.
Fees
There is no cost linked to the increase of the joint submission tonnage band, fees are levied only for the increase of the tonnage band of a registration. Therefore, as long as the lead registrant only increases the tonnage band of the joint submission, but not their own registration, they will not incur any additional fee. On the other hand, when the member registrant submits their updated dossier at an increased tonnage band, they will receive a new invoice.
Member registrants of a joint submission (including the lead registrant) contribute only to the cost of the data they need and the applicable administrative charges. If only one member registrant needs additional studies, they alone will need to pay for the cost of that data. Should later on another registrant require the new, higher tonnage band, then the costs of the data / studies performed need to be shared amongst the registrants who require those.
Opt-out
In case the data that is required for the higher tonnage band is only available for the specific member registrant, who wishes to update their dossier, they can decide not to share it with the lead registrant, but instead include it in their own dossier and submit an opt-out for the higher tonnage band.
By submitting an opt-out dossier you will not be entitled to the reduced joint submission fees. Furthermore, any registrant who in the future wishes to update their registration to this higher tonnage band would have to include the data in their dossier separately. For this reason, ECHA recommends that the lead registrant’s dossier contains all information, regardless of their tonnage band. Alternatively, and only if the majority of co-registrants support it, the member registrant can take over the lead role of the joint submission.