如何在 REACH-IT 中提交 Read-Across 查询，以获取有关至少 12 年前在另一种物质的档案中提交的研究的信息？

如何在 REACH-IT 中提交 Read-Across 查询，以获取有关至少 12 年前在另一种物质的档案中提交的研究的信息？

How do I submit a Read-Across inquiry in REACH-IT to receive information on studies submitted at least 12 years previously in a dossier of another substance?

如果您希望在您的注册档案中开发某种物质的横向阅读和分组调整，您可以使用至少 12 年前在另一种物质的档案中提交的（稳健）研究摘要 (RSS)。在这种情况下，您可以根据 REACH 第 25(3) 条在 REACH-IT 中提交横向阅读查询，以请求有关此类数据的信息。请注意，每次查询只能请求一种物质的 RSS 信息。横向阅读查询档案是在 IUCLID 中创建的。请遵循手册“如何准备查询档案”（可在 https://echa.europa.eu/manuals 上找到）中的技术说明。在横向阅读查询档案中，您需要：向 ECHA 提供您的查询或注册编号，表明您注册的真实意图或更新您的注册档案。在 IUCLID 第 1.3 节“标识符”中注明注册/查询编号：在 IUCLID 第 14 节“信息要求”中将“查询类型”指定为“横向研究查询”[类型 5]，在 IUCLID 第 14 节“信息要求”中注明您需要 12 年以上以前提交 RSS 的物质的 EC 编号，在 IUCLID 第 14 节“信息要求”中列出您需要信息的终点。准备好卷宗后，即可在 REACH-IT 中提交：我们提醒您，REACH 第 25(3) 条指出“根据本法规在注册框架内提交的任何研究摘要或强化研究摘要，至少在 12 年前，均可由其他制造商或进口商用于注册目的。”但请注意，潜在注册人必须评估12年前提交的RSS的质量。因此，（潜在）注册人应优先联系数据提交者，获取RSS访问权限并讨论其质量和可靠性。之前的注册人不得就使用这些RSS进行注册而向潜在注册人索取赔偿。如果您在调查过程中未能就使用至少12年前提交的RSS进行协商，您可以作为最后的手段联系ECHA帮助台。

If in your registration dossier you are interested in developing a read-across and grouping adaptation on a substance, you may use (robust) study summaries (RSS) submitted at least 12 years previously in a dossier for another substance. In that case, you can submit a read-across inquiry in REACH-IT to request information on such data in accordance with Article 25(3) of REACH. Note that you can only request information on RSS for one substance per one inquiry. The read-across inquiry dossier is created in IUCLID. Follow the technical instructions given in the manual ‘How to prepare an inquiry dossier’ (available at https://echa.europa.eu/manuals).In the read-across inquiry dossier you are required to: Show your real intentions to register, or update your registration dossier, by providing ECHA your inquiry or registration number. Indicate the registration/inquiry number in IUCLID section 1.3 ‘Identifiers’:Specify the ‘Type of inquiry’ as “inquiry for read-across studies’ [Type 5] in IUCLID section 14 ‘Information requirements’,Indicate the EC number of the substance for which you need the RSS submitted more than 12 years previously in IUCLID section 14 ‘Information requirements’,List the endpoints that you would require information for in IUCLID section 14 ‘Information requirements’Once you have prepared your dossier, you can submit it in REACH-IT:We remind you that Article 25(3) of REACH indicates that “Any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regulation at least 12 years previously can be used for the purposes of registration by another manufacturer or importer.” Please however note that the quality of the RSS submitted 12 years previously must be assessed by the potential registrants. Therefore, as a priority (potential) registrants should contact the data submitters to get access to the RSS and to discuss their quality and reliability. The previous registrants must not claim compensation from the potential registrant for using those RSS for registration purposes.In case under the inquiry process you fail to negotiate the use of RSS submitted at least 12 years previously, you may, as a last resort contact the ECHA Helpdesk.