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Dataset
Data sources: ZENODO
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Crosswalks IUCLID 6 v10 EU PPP Microorganisms - active substance application (product) to Data Requirements

Authors: European Food Safety Authority (EFSA);

Crosswalks IUCLID 6 v10 EU PPP Microorganisms - active substance application (product) to Data Requirements

Abstract

The Excel file provides detailed crosswalks from the current Table of Content (ToC) for Microbial Plant Protection Product (PPP) dossier in IUCLID 6 v.10 to Commission Regulation (EU) 283/2013 and Commission Regulation (EU) 284/2013 as amended by Commission Regulation (EU) 2022/1439 & Commission Regulation (EU) 2022/1440. There are two worksheets: ACTIVE SUBSTANCE (283-2013): mapping between the current IUCLID working context "EU PPP Microorganisms - active substance information" to the Commission Regulation (EU) No 283/2013 as amended by Commission Regulation (EU) 2022/1439. PRODUCT (284-2013): mapping between the the current IUCLID working context "EU PPP Microorganisms - active substance application (product)" to the Commission Regulation (EU) No 284/2013 as amended by Commission Regulation (EU) 2022/1440. The spreadsheets contain the following columns: Data Requirements Section (Commission Regulation (EU) 2022/1439 or 2022/1440): the name of the ToC section (in accordance with the new data requirements). IUCLID section: the name of the ToC section in IUCLID. 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: fulI IUCLID paths indicating the section of the respective document where information needs to be provided and/or specific values to be indicated. Note: in cases where an IUCLID document is not included in the updated ToC this will be found in a specific section 'Documents applicable to the former data requirements' which can be found at the end of the dataset. Version 6 includes changes in the table of contents of IUCLID 6 v10.

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