Crosswalks EU PPP Microorganisms - active substance application (product) to New Data Requirements Regulation (EU) 2022/1439 & Regulation (EU) 2022/1440

In this version 2, a <strong>word file</strong> has been included providing <strong>clarifications </strong>on the <strong>transitional period</strong> in <strong>IUCLID</strong> for the submission of dossiers on microbial pesticides after the October 2022 release and in view of the April 2023 format release. The <strong>Excel file</strong> provides detailed crosswalks from the current Table of Content in IUCLID ( Reg 283/2013 and Reg 284/2013 as stood before being amended by Regulation (EU) 2022/1439 &amp; Regulation (EU) 2022/1440”) to Reg 283/2013 and Reg 284/2013 as amended by Regulation (EU) 2022/1439 &amp; Regulation (EU) 2022/1440. There are two worksheets: <strong>ACTIVE SUBSTANCE</strong> (2022 - 1439) : mapping between the current IUCLID working context "EU PPP Microorganisms - active substance information" to the Regulation (EU) No 283/2013 as amended by Regulation (EU) 2022/1439 <strong>PRODUCT</strong> (2022 - 1440) : mapping between the the current IUCLID working context "EU PPP Microorganisms - active substance application (product)" to the Regulation (EU) No 284/2013 as amended by Regulation Regulation (EU) 2022/1440 The spreadsheets contain the following columns: <strong>New Data Requirements Section (October 2022)</strong> : The name of the TOC section (according to the new data requirements) <strong>Document changes</strong> : the documents which have been added to the working context to meet the new data requirements <strong>Document change type</strong> : the type of document changes made to meet the new data requirements - documents which have been added or replaced in the IUCLID October 2022 Release and the new documents which will be added in the IUCLID April 2023 Release <strong>IUCLID section IUCLID 6.6 (17 October 2021)</strong> :The name of the TOC section (according to the previous data requirements) <strong>Endpoint study record</strong>: name of the document template used to report individual studies of the section. These usually correspond to OECD Harmonised Templates (OHT). <strong>Endpoint summary</strong>: name of the document template used to report the summary information for the section endpoints <strong>Other IUCLID document</strong>: name of any other document template in IUCLID used to report information of the section <strong>OHT</strong>: number of the OECD Harmonised Template used in the section <strong>Additional context</strong>: This section provides instructions for dossier preparation to meet the new data requirements and where the the Cf. (cross reference) is specified in a TOC section the the IUCLID path for the fields which should be completed. Note: In cases where an IUCLID document is not included in the updated table of contents this will be found in a specific section 'Previously used documents now obsolete, kept until April 2024' which can be found at the end of the dataset.本V2版本新增了一份Word文档，针对2022年10月版本发布后、2023年4月格式版本发布前的过渡期内，微生物农药申报卷宗在IUCLID（国际统一化学品信息数据库）中的相关事宜提供说明。本Excel文件提供了详细的映射对照表，涵盖未被《欧盟条例（EU）2022/1439》与《欧盟条例（EU）2022/1440》修订的《欧盟法规（Reg）283/2013》及《欧盟法规（Reg）284/2013》所对应的IUCLID当前目录体系，到经上述两项条例修订后的同一法规目录体系的映射关系。该Excel文件包含两个工作表：**ACTIVE SUBSTANCE（有效物质，2022-1439）**：映射当前IUCLID工作语境下「欧盟植物保护产品-微生物-有效物质信息」与经《欧盟条例（EU）2022/1439》修订的《欧盟条例（EU）No 283/2013》之间的对应关系；**PRODUCT（产品，2022-1440）**：映射当前IUCLID工作语境下「欧盟植物保护产品-微生物-有效物质申报（产品）」与经《欧盟条例（EU）2022/1440》修订的《欧盟条例（EU）No 284/2013》之间的对应关系。该表格包含以下列项：**New Data Requirements Section（新数据要求章节，2022年10月）**：新数据要求下的目录章节名称；**Document changes（文档变更项）**：为满足新数据要求而新增至工作语境的文档；**Document change type（文档变更类型）**：为满足新数据要求所开展的文档变更类型——涵盖IUCLID 2022年10月版本中新增或替换的文档，以及将在IUCLID 2023年4月版本中新增的文档；**IUCLID section IUCLID 6.6 (17 October 2021)（IUCLID章节，IUCLID 6.6，2021年10月17日）**：旧数据要求下的目录章节名称；**Endpoint study record（终点研究记录）**：用于报告该章节中单项研究的文档模板名称，此类模板通常对应经合组织协调模板（OECD Harmonised Templates，OHT）；**Endpoint summary（终点汇总表）**：用于报告该章节各终点汇总信息的文档模板名称；**Other IUCLID document（其他IUCLID文档）**：IUCLID中用于报告该章节信息的其余文档模板名称；**OHT（OHT编号）**：该章节所使用的经合组织协调模板编号；**Additional context（附加说明）**：本章节提供满足新数据要求的卷宗编制指南，同时针对目录章节中注明的参见（交叉引用）项，明确需填写字段的IUCLID路径。备注：若某份IUCLID文档未纳入更新后的目录体系，可在本数据集末尾的「已停用旧文档（保留至2024年4月）」专属章节中找到该文档。