Dataset Open Access

Crosswalks IUCLID 6.6 EU PPP Microorganisms - active substance application (product) to KMA&KMP

European Food Safety Authority (EFSA)


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    <dct:title>Crosswalks IUCLID 6.6 EU PPP Microorganisms - active substance application (product) to KMA&amp;KMP</dct:title>
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    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#gYear">2021</dct:issued>
    <dcat:keyword>IUCLID</dcat:keyword>
    <dcat:keyword>plant protection products</dcat:keyword>
    <dcat:keyword>pesticides</dcat:keyword>
    <dcat:keyword>EU table of contents (ToC)</dcat:keyword>
    <dcat:keyword>crosswalk</dcat:keyword>
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    <dct:description>&lt;p&gt;This Excel file provides detailed crosswalks from the &lt;a href="https://esubmission.ecpa.eu/toc/EU"&gt;EU Table of Contents (SANCO/10181/2013)&lt;/a&gt;&amp;nbsp;for microbial plant protection product (PPP) dossiers to &lt;a href="https://iuclid6.echa.europa.eu/"&gt;IUCLID 6.6&lt;/a&gt;. 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):&lt;/p&gt; &lt;ul&gt; &lt;li&gt;&lt;strong&gt;EU_PPP_Micro_ActiveSubstance&lt;/strong&gt;: mapping between the &amp;quot;KMA&amp;quot; ToC and IUCLID 6.5&amp;#39;s working context &amp;quot;EU PPP Microorganisms - active substance information&amp;quot;&lt;/li&gt; &lt;li&gt;&lt;strong&gt;EU_PPP_Micro_Product&lt;/strong&gt;: mapping between the &amp;quot;KMP&amp;quot; ToC and IUCLID 6.5&amp;#39;s working context &amp;quot;EU PPP Microorganisms - active substance application (product)&amp;quot;&lt;/li&gt; &lt;/ul&gt; &lt;p&gt;The spreadsheets map each section of&amp;nbsp;the original EU ToC to:&lt;/p&gt; &lt;ul&gt; &lt;li&gt;&lt;strong&gt;&lt;em&gt;IUCLID section&lt;/em&gt;&lt;/strong&gt;: name of the section in IUCLID where to input the corresponding data/information&lt;/li&gt; &lt;li&gt;&lt;em&gt;&lt;strong&gt;Endpoint study record&lt;/strong&gt;&lt;/em&gt;: name of the document template used to report individual studies of the section (if exists). These usually correspond to OECD&amp;nbsp;Harmonised Templates (OHT).&lt;/li&gt; &lt;li&gt;&lt;em&gt;&lt;strong&gt;Endpoint summary&lt;/strong&gt;&lt;/em&gt;: name of the document template used to report the summary information of the studies presented in the section (if exists)&lt;/li&gt; &lt;li&gt;&lt;em&gt;&lt;strong&gt;Other IUCLID document&lt;/strong&gt;&lt;/em&gt;: name of any other&amp;nbsp;document template&amp;nbsp;in IUCLID used to report information of the section (if exists)&lt;/li&gt; &lt;li&gt;&lt;em&gt;&lt;strong&gt;OHT&lt;/strong&gt;:&lt;/em&gt;&amp;nbsp;name/id&amp;nbsp;of the OECD Harmonised Template used for the endpoint study record document (if exists)&lt;/li&gt; &lt;li&gt;&lt;em&gt;&lt;strong&gt;Additional context&lt;/strong&gt;&lt;/em&gt;: fulI IUCLID paths indicating the section of the respective document where information&amp;nbsp;needs to be provided and/or specific values to be indicated. If more than one path is provided, these are separated by &amp;quot;;&amp;quot;. Operators &amp;quot;=&amp;quot; and &amp;quot;!=&amp;quot; are used to indicate values to be used and to be avoided, respectively. When more than one value is possible, &amp;quot;IN&amp;quot;&amp;nbsp;and &amp;quot;NOT IN&amp;quot; operators are used, followed by the exhaustive&amp;nbsp;list of possible values. This nomenclature was defined with the aim of making contents machine-readable.&lt;/li&gt; &lt;/ul&gt; &lt;p&gt;&lt;strong&gt;Version 3&amp;nbsp;&lt;/strong&gt;includes changes in the table of contents of IUCLID6.6.&lt;/p&gt;</dct:description>
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