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我需要数据进行横向参照。如何联系其他联合提交的数据提交者?
问题(中文)
我需要数据进行横向参照。如何联系其他联合提交的数据提交者?
Question (EN)
I need data for a read-across. How can I contact the data submitters from another joint submission?
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)
目前没有正式的程序可以联系其他物质的先前注册人和潜在注册人进行交叉参考。您可以在我们的注册物质传播门户网站上找到已注册该物质的公司,并联系任何出现名称的注册人,索取主要注册人的联系方式。然后,您可以联系他们协商数据共享协议。ECHA 开发了其 IT 工具,允许提交交叉参考查询的各方访问其计划进行交叉参考调整的源物质的 REACH-IT 共同注册人页面。这样就可以访问已提交研究的列表以及数据提交者相应的联系方式。您可以按照以下步骤提交交叉参考查询:1. 使用 IUCLID 创建交叉参考查询档案。您可以使用“正常”的 IUCLID 查询数据集(根据第 26 条或第 12 条)作为模板,但需要进行以下修改:· 通过向 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”中注明查询/注册编号。· 在 IUCLID 第 14 节“信息要求”中将“查询类型”指定为“横向参照研究查询”[类型 5]。· 在 IUCLID 第 14 节“信息要求”中提供您计划的横向参照调整的源物质的 EC 编号。· 在 IUCLID 第 14 节“信息要求”中列出您需要信息的终点。2. 创建卷宗并在 REACH-IT 中提交(提交 > 查询 > 上传用于横向参照查询的 IUCLID 卷宗)。请注意,出于横向参照目的,不同物质之间数据共享并非强制性的。但是,2016 年 1 月 5 日关于数据联合提交和数据共享的委员会实施条例 (EU) 2016/9 强调了不同物质之间数据共享的好处。因此,强烈建议类似物质之间共享数据,但 ECHA 不能强制执行。如果您需要的横向参照数据与至少 12 年前提交的研究相关,您可以根据 REACH 法规第 25(3) 条的规定,在 REACH-IT 中提交横向参照查询,请求获取此类数据的信息。更多详情,请参阅我们的问答 2032。
Answer (EN)
There is no formal procedure to get in contact with the previous registrants and potential registrants of another substance for read-across purposes. You can find the companies that registered a substance in our dissemination portal for registered substances, and contact any of the registrants whose name appears, asking for the lead registrant’s contact details. You can then contact them to negotiate a data sharing agreement.ECHA has developed its IT tools to also allow the parties that submit a read-across inquiry to access the REACH-IT Co-registrants’ page of the source substance of their planned read-across adaptation. This gives access to the list of studies submitted and to the corresponding contact details of the data submitters.You can submit a read-across inquiry by following the below steps:1.Create a read-across inquiry dossier with IUCLID. You can use your “normal” IUCLID inquiry dataset (according to article 26 or 12) as a template, but make the following modifications:· Show your real intentions to register, or update your registration dossier, by providing ECHA with your inquiry or registration number. Indicate the inquiry/registration 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.· Provide the EC number of the source substance of your planned read-across adaptation in IUCLID section 14 ‘Information requirements’.· List the endpoints that you would require information for in IUCLID section 14 ‘Information requirements.2.Create the dossier and submit it in REACH-IT (Submit > Inquiry > Upload a IUCLID dossier for a read-across inquiry).Please note that data sharing between different substances for read-across purposes is not mandatory. However, the Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data sharing underlines the benefits of data sharing between different substances. Therefore, data sharing between similar substances is strongly recommended, but it cannot be imposed by ECHA.If the data you need for read-across relates to studies submitted at least 12 years previously, you can submit a read-across inquiry in REACH-IT to request information on such data in accordance with Article 25(3) of REACH. Please see our Q&A 2032 for further details.