潜在注册人如何选择退出联合提交？

潜在注册人如何选择退出联合提交？

How can a potential registrant opt out of a Joint Submission?

a) 选择退出的原因如果对特定端点存在分歧，则可以根据第 11(3) 条（或中间体的情况下为第 19(2) 条）选择退出信息，如果：• 联合提交此信息的成本过高；或• 这将导致泄露被视为商业敏感的信息并可能造成重大损害；或• 对此信息的选择存在分歧。在这种情况下，成员注册人可以提交部分或全部退出联合提交，并包括共同注册人想要退出的所有端点。b) 选择退出联合提交的成员注册人的义务提交退出（部分或全部）的注册人必须继续作为提交的成员并参与数据共享谈判。即使成员完全选择退出联合提交，也可能会被要求分担与联合提交管理相关的行政费用。如果选择退出，您需要：• 继续参与联合提交，• 提交您自己的信息以满足数据要求，• 提交明确且合理的退出理由，• 在 IUCLID 档案的第 14 部分中包含退出信息。 c) 准备成员注册人的档案：• 如果成员注册人依赖牵头注册人提供的信息，则他不应在成员档案的第 2.1、4、5、6、7 和 8 部分填写任何数据；• 如果成员注册人提交的档案填写了其中任何一部分，则该提交将被视为选择退出（见下图）：只有链接到第 14 部分端点“REACH 注册的选择退出信息”的第 2.1 部分和 4-7 部分端点研究记录文件才会包含在档案中。确保在完成档案创建之前，已将计划包含在档案中的所有研究记录文件链接到此第 14 部分端点。如果您对选择退出的数据有不同的理由，请将链接的文档按块分组，以便您提供的理由与同一块中的文档相关。终点摘要不被视为退出信息，但如果您选择退出终点信息或提供您自己的化学品安全报告，则仍需提供。选择退出时，如果您使用联合提交成员模板，完整档案中某些必填部分不会被自动预选纳入 IUCLID 档案。因此，在创建档案时，必须手动选择终点摘要记录，包括第 6 部分“生态毒理学信息”和第 7 部分“毒理学信息”。有关准备退出档案的指南，请参阅《如何准备注册和 PPORD 档案》手册的第 8.9.2 和 9.2 节。 d) REACH-IT 中成员注册人的退出状态：• 如果成员注册人未选择退出，或仅选择退出第 2.1 节（分类和标签以及 PBT 评估），则退出状态标记为否。• 如果成员注册人选择退出任何其他部分（即 4、5、6、7），则退出状态标记为是。

a) Reasons for opting outIn case there is a disagreement regarding a specific endpoint, you may opt out of information according to Article 11(3) (or 19(2) in case of intermediates) if:• it is disproportionately costly to submit this information jointly; or• it would lead to the disclosure of information which is considered to be commercially sensitive and may cause substantial detriment; or• there is disagreement on the selection of this information.In such cases, a member registrant can submit a partial or full opt-out of the joint submission and include all endpoints the co-registrant wants to opt out for. b) Duties of a member registrant who opts out of the joint submissionA registrant that submits an opt-out (partial or full) must remain a member of the submission and participate in data-sharing negotiations. Even a member who fully opts out of the joint submission may be requested to share administrative costs associated with the management of the joint submission.In case of an opt-out, you are required to:• remain part of the joint submission,• submit your own information to cover the data requirement,• submit a clear and reasoned justification for opting out,• include opt-out information in section 14 of IUCLID dossier. c) Preparation of a member registrant’s dossier:• If a member registrant relies on the information provided by the lead registrant, he should not fill in any data to sections 2.1, 4, 5, 6, 7 and 8 of the member dossier;• If a member registrant submits a dossier with any of these sections filled in, the submission is regarded as an opt-out (see picture below): Only the section 2.1 and 4-7 endpoint study record documents that you link to the section 14 endpoint ‘Opt-out information for REACH registration’ will be included in the dossier. Ensure that you have linked all the study record documents that you planned to include in the dossier to this section 14 endpoint before you finalise the dossier creation. If you have different justifications for the data that you opt-out with, group the linked documents per blocks so that the justification you provide is relevant for the documents in the same block. Endpoint summaries are not considered as opt-out information but are still required if you are opting-out with endpoint information or are providing your own Chemical Safety Report. When opting-out, some of the sections that are mandatory for a complete dossier are not automatically pre-selected for inclusion in the IUCLID dossier when you use the joint submission member template. Therefore, when creating your dossier, endpoint summary records including section 6 ‘Ecotoxicological information’ and section 7 ‘Toxicological information’ must be selected manually. Guidance on preparing an opt-out dossier can be found in sections 8.9.2 and 9.2 of the manual How to prepare registration and PPORD dossiers. d) Opt-out status of member registrants in REACH-IT:• The opt-out status is marked no, if the member registrant did not opt out, or has only opted out of section 2.1 (Classification & Labelling and PBT assessment).• The opt-out status is marked yes, if the member registrant opted-out of any other sections (i.e. 4, 5, 6, 7).