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如果物质是进口的,并且未在欧洲经济区进一步加工,注册人如何在 IUCLID 档案中表明对人类健康终点信息要求的调整请求?
问题(中文)
如果物质是进口的,并且未在欧洲经济区进一步加工,注册人如何在 IUCLID 档案中表明对人类健康终点信息要求的调整请求?
Question (EN)
How can a Registrant indicate the request for adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and not further processed in the EEA?
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)
在 IUCLID 6 中,REACH 下“豁免”标准信息要求的请求必须记录在“数据豁免”字段中,并且必须为每个提出豁免的终端记录“数据豁免理由”。创建或更新注册档案时,请遵循以下说明。待提供信息的描述已按“IUCLID 部分”和“字段”进行组织。此外,还区分了物质数据集中需要输入的信息和只能在创建档案时输入的信息。请从“选择/输入”列中使用适当的选择列表选择和建议的标准文本,以便在相应的“字段”中输入。如果物质仅以最终状态(未在欧洲经济区内进一步加工或重新包装)以化妆品形式进口到欧洲经济区,则豁免可能性仅与人类健康终点有关,并且仅基于在生命周期的任何阶段均无与 REACH 相关的用途(不会接触工人;化妆品法规涵盖了专业人士和消费者的接触)。以下特定数据豁免仅适用于人类健康信息要求(REACH 附件 VII-X 第 8 节)。*数据豁免仅适用于 REACH 附件所要求的与注册档案相对应的吨位范围的终点。 ** IUCLID 第 3.5.5 节:消费者用途中填写的每种用途所需提供的信息,在《如何准备注册和 PPORD 档案》(第 9.6.4.3 章和附件 2)手册中进行了说明。该手册可在 ECHA 网站(支持 > 手册)下获取,也可在 IUCLID 6 帮助系统中获取。***所有化妆品以外的用途均须在第 3.5 节中记录**** 每种更新原因均应单独填写说明。
Answer (EN)
In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier.Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.If the substance is only imported in the EEA in a cosmetic product in its final state (neither further processed nor repackaged inside the EEA), the waiving possibility is only relevant for human health endpoints and is only based on the fact that there are no uses in any stage of the life-cycle which may be relevant to REACH (no exposure to workers; exposure to professionals and consumers is covered by the Cosmetics Regulation).The following specific data waivers can be used only for human health information requirements (Sections 8 of REACH Annexes VII-X).* Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier. ** The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.***All uses outside the cosmetic use have to be documented in Section 3.5**** A separate justification should be entered for each reason for the update.