我想解释一下由于费用过高而选择退出的理由。我应该提供哪些信息？

我想解释一下由于费用过高而选择退出的理由。我应该提供哪些信息？

I want to justify opting-out due to disproportionate cost. What information should I provide?

必须在 IUCLID 第 14 节“信息要求”中“REACH 注册退出信息”记录的“理由”字段中提供理由，解释为什么可以根据 REACH 法规第 11(3) 条或 19(2) 条单独提交信息。为了帮助您提供有效的理由，在“理由”字段中提供了模板（单击图标 A）。模板问题也可在手册“如何准备注册和 PPORD 档案”的附件 7 中找到。理由中预期的信息：访问联合提交数据的成本。您应该已经从主注册人处获得了此信息。如果您无法从主注册人处获得此信息，您应该解释您为尝试获取此信息所采取的行动以及主注册人的回复。完成和提交退出档案的费用。请记住您自己与准备档案相关的可能内部成本。您不应为此答案提供零。请解释为什么联合提交这些数据的成本过高。以下是一些解释依据的示例：您的注册类型与联合注册不同。您的注册吨位范围和相关数据要求不同，例如，附件七要求通过附件八研究来满足。数据类型，例如，公开数据、自有数据、其他低成本数据（例如 QSAR）。成本细分的质量和清晰度。解释为商定访问联合提交数据的成本而采取的措施。

A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7.  Information expected in the justification: Cost of accessing the jointly submitted data. You should have received this information from the lead registrant. If you have not been able to obtain this information from the lead registrant you should explain the actions you took to try and obtain this information and the lead registrant’s response. Cost of completing and submitting your opt-out dossier. Bear in mind your own possible internal costs related to preparing the dossier. You should not provide a figure of zero for this answer. Explain why submitting this data jointly would be disproportionately costly. See below some examples for the basis of your explanation: Your registration type being different from the joint registration. Your registration tonnage band and the associated data requirements being different, e.g., Annex VII requirement fulfilled with an Annex VIII study. Type of data, e.g., data publicly available, own data available, other data available at lower cost (e.g. QSAR). Cost breakdown quality and clarity. Explain the measures taken to agree on the cost of accessing the jointly submitted data.