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Crosswalks IUCLID 6.5 EU PPP Microorganisms - active substance application (product) to KMA&KMP

European Food Safety Authority (EFSA)

This Excel file provides detailed crosswalks from the EU Table of Contents (SANCO/10181/2013) for microbial plant protection product (PPP) dossiers to IUCLID 6.5. It includes two spreadsheets, containing the mappings for active substance (as laid out in Commission Regulation (EU) No 283/2013) and representative product (Commission Regulation (EU) No 284/2013):

  • EU_PPP_Micro_ActiveSubstance: mapping between the "KMA" ToC and IUCLID 6.5's working context "EU PPP Microorganisms - active substance information"
  • EU_PPP_Micro_Product: mapping between the "KMP" ToC and IUCLID 6.5's working context "EU PPP Microorganisms - active substance application (product)"

The spreadsheets map each section of the original EU ToC to:

  • IUCLID section: name of the section in IUCLID where to input the corresponding data/information
  • Endpoint study record: name of the document template used to report individual studies of the section (if exists). These usually correspond to OECD Harmonised Templates (OHT).
  • Endpoint summary: name of the document template used to report the summary information of the studies presented in the section (if exists)
  • Other IUCLID document: name of any other document template in IUCLID used to report information of the section (if exists)
  • OHT: name/id of the OECD Harmonised Template used for the endpoint study record document (if exists)
  • 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. If more than one path is provided, these are separated by ";". Operators "=" and "!=" are used to indicate values to be used and to be avoided, respectively. When more than one value is possible, "IN" and "NOT IN" operators are used, followed by the exhaustive list of possible values. This nomenclature was defined with the aim of making contents machine-readable.
EU; XLSX; data.collection@efsa.europa.eu
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