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 word file has been included providing clarifications on the transitional period in IUCLID for the submission of dossiers on microbial pesticides after the October 2022 release and in view of the April 2023 format release.

The Excel file 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 & Regulation (EU) 2022/1440”) to Reg 283/2013 and Reg 284/2013 as amended by Regulation (EU) 2022/1439 & Regulation (EU) 2022/1440.

There are two worksheets:

• ACTIVE SUBSTANCE (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
• PRODUCT (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:

• New Data Requirements Section (October 2022) : The name of the TOC section (according to the new data requirements)  
• Document changes : the documents which have been added to the working context to meet the new data requirements
• Document change type : 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
• IUCLID section IUCLID 6.6 (17 October 2021) :The name of the TOC section (according to the previous data requirements)  
• Endpoint study record: name of the document template used to report individual studies of the section. These usually correspond to OECD Harmonised Templates (OHT). 
• Endpoint summary: name of the document template used to report the summary information for the section endpoints
• Other IUCLID document: name of any other document template in IUCLID used to report information of the section  
• OHT: number of the OECD Harmonised Template used in the section
• Additional context: 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.