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我的提交未通过 BR119 。我该怎么办?
问题(中文)
我的提交未通过 BR119 。我该怎么办?
Question (EN)
My submission failed BR119 . What should I do?
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)
业务规则 119 (BR119) 失败发生在牵头注册人在其档案更新中表示不会代表其成员提供可选信息(即化学品安全报告 (CSR) 和安全使用指南 (GoSU)),尽管他们在之前的提交中表示将提供此类信息。以下情况可能会触发 BR119 失败:如果牵头注册人最初表示他们将代表联合提交的所有成员提供 CSR 和/或 GoSU,但不再希望这样做,则他们应提交自发更新。提交更新前:主注册人应首先确保变更不会影响联合提交的任何成员。依赖主注册人提供的 CSR 和/或 GoSU 的成员需要提交自发更新,表明他们将提供单独的 CSR 和/或 GoSU。提交自发更新时,成员或主注册人应在 IUCLID 档案中将提交类型注明为“自发更新”,根据自身情况选择相关原因,并在“备注”字段中输入说明。创建档案时,我们建议您使用 IUCLID 验证助手插件,以帮助您检测数据集和档案中的业务规则和技术完整性检查失败情况。有关如何使用验证助手的更多说明,请参阅问答 392。
Answer (EN)
Business rule 119 (BR119) failure occurs when the lead registrant indicates in their dossier update that they will not provide the optional information (i.e. chemical safety report (CSR) and guidance on safe use (GoSU)) on behalf of its members although in the previous submission they had indicated that they would provide this information.The following scenarios may trigger BR119 failure:If the lead registrant initially indicated that they would provide the CSR and/or GoSU on behalf of all members of the joint submission but no longer wishes to do so, they should submit a spontaneous update. Before submitting their update:The lead registrant should first ensure that the changes will not affect any members of the joint submission.Members relying on the CSR and/or GoSU provided by the lead registrant need to submit a spontaneous update indicating that they will provide individual CSRs and/or GoSUs.When submitting the spontaneous update, member or lead registrants should indicate in the IUCLID dossier the submission type as ‘spontaneous update’, select a relevant reason depending on their situation and enter a clarification in the ‘Remarks’ field.While creating the dossier, we advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier. For further instructions on how to use the validation assistant please refer to Q&A 392.