Question (EN)
How can a Registrant indicate an adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and further processed in the EEA, without exposure to workers?
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端点记录“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仅在创建档案时才能输入的信息。请在“选择/输入”栏中选择合适的选择列表，并在相应的“字段”中输入建议的标准文本。如果该物质在欧洲经济区 (EEA) 内进行进一步加工，即进口或生产，并在最终纳入化妆品之前或之后进一步配制或重新包装，则您需要证明该物质未暴露于工人，才能享受调整优惠。这种情况也适用于无需提供暴露评估的情况：由于生产或进口的物质吨位较低，无需进行企业社会责任 (CSR)，或者由于该物质无需分类，无需进行暴露评估。因此，您应该根据情况，使用暴露场景和/或其他方法记录未暴露的情况。您可以申请以下特定的数据豁免，特别是针对人类健康信息要求（REACH 附件 VII-X 第 8 节）。*数据豁免仅适用于 REACH 附件针对注册档案对应吨位段所要求的终点。 **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，已在《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。另请参阅：https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf
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 further processed inside the EEA, i.e. it is imported or manufactured in the EEA, and still further formulated or re-packaged, before or after inclusion in the final cosmetic product, you need to demonstrate the absence of exposure to workers to benefit from the adaptation possibility.This case also covers situations where you do not need to provide an exposure assessment: either no CSR is required due to the low tonnage of the substance manufactured or imported, or no exposure assessment is required because the substance does not require classification.Consequently, you should document the absence of exposure as appropriate, using exposure scenarios and/or other approaches. You can apply for the following specific data waivers, specifically for the 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.See also: https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf