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10 results for “IUCLID”
Crosswalks IUCLID 6 v9 EU PPP Microorganisms - active substance application (product) to Data Requirements
<p>The <strong>Excel file</strong> provides detailed crosswalks from the current Table of Content (ToC) for Microbial Plant Protection Product (PPP) dossier in <a href="https://iuclid6.echa.europa.eu/it/home">IUCLID 6 v.9</a> 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.</p> <p>There are two worksheets:</p> <ul> <li><strong>ACTIVE SUBSTANCE</strong> (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.</li> <li><strong>PRODUCT</strong> (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.</li> </ul> <p>The spreadsheets contain the following columns:</p> <ul> <li><strong>Data Requirements Section (Commission Reguation (EU) 2022/1439 or 2022/1440)</strong>: the name of the ToC section (in accordance with the new data requirements).</li> <li><strong>IUCLID section</strong>: the name of the ToC section in IUCLID.</li> <li><strong>Endpoint study record</strong>: name of the document template used to report individual studies of the section. These usually correspond to <a href="https://www.oecd.org/en/topics/sub-issues/assessment-of-chemicals/harmonised-templates.html">OECD Harmonised Templates (OHT)</a>. </li> <li><strong>Endpoint summary</strong>: name of the document template used to report the summary information for the section endpoints.</li> <li><strong>Other IUCLID document</strong>: name of any other document template in IUCLID used to report information of the section. </li> <li><strong>OHT</strong>: number of the OECD Harmonised Template used in the section.</li> <li><strong>Additional context</strong>: fulI IUCLID paths indicating the section of the respective document where information needs to be provided and/or specific values to be indicated. </li> </ul> <p>Note: <span>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.</span></p> <p><strong>Version 5 </strong>includes changes in the table of contents of <a href="https://iuclid6.echa.europa.eu/it/home">IUCLID 6 v9</a>.</p> <p> </p> <p> </p>
Crosswalks IUCLID 6 v9 EU PPP Active substance application (product) to KCA&KCP
<p>This Excel file provides detailed crosswalks from the <a href="https://esubmission.croplifeeurope.eu/registration-for-download/">EU Table of Contents (SANCO/10181/2013)</a> for plant protection product (PPP) dossiers to <a href="https://iuclid6.echa.europa.eu/it/home">IUCLID 6 v9</a>. 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):</p> <ul> <li><strong>EU_PPP_ActiveSubstance</strong>: mapping between the "KCA" ToC and IUCLID 6 v9 working context "EU PPP Active substance information"</li> <li><strong>EU_PPP_Product</strong>: mapping between the "KCP" ToC and IUCLID 6 v9 working context "EU PPP Active substance application (product)"</li> </ul> <p>The spreadsheets map each section of the original EU ToC to:</p> <ul> <li><strong><em>IUCLID section</em></strong>: name of the section in IUCLID where to input the corresponding data/information</li> <li><em><strong>Endpoint study record</strong></em>: name of the document template used to report individual studies of the section (if exists). These usually correspond to <a href="https://www.oecd.org/en/topics/sub-issues/assessment-of-chemicals/harmonised-templates.html">OECD Harmonised Templates (OHT)</a>.</li> <li><em><strong>Endpoint summary</strong></em>: name of the document template used to report the summary information of the studies presented in the section (if available)</li> <li><em><strong>Other IUCLID document</strong></em>: name of any other document template in IUCLID used to report information of the section (if available)</li> <li><em><strong>OHT</strong>:</em> name/id of the OECD Harmonised Template used for the endpoint study record document (if available)</li> <li><em><strong>Additional context</strong></em>: 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.</li> </ul> <p><strong>Version 6 </strong>includes changes in the table of contents of IUCLID 6 v9.</p>
IUCLID templates for PPP Risk Assessment - Template 7.2 - Template for presenting the results of the OECD 106 evaluators checklist
<p>This word file contains the template for <strong>presenting the results of the OECD 106 evaluators checklist</strong>. The template has been draft based on the Technical report on the outcome of the pesticides peer review meeting on the OECD 106 evaluators checklist (EFSA, 2017).<br> The filled-in template shall be pasted in the "<strong>Any other information on results incl. tables</strong> " field of IUCLID document “<strong>Adsorption and desorption in soil</strong>”<strong> </strong>endpoint study record (Section 7.1.3.1 of active substance dataset).</p>
Crosswalks IUCLID 6.6 EU PPP Microorganisms - active substance application (product) to KMA&KMP
<p>This Excel file provides detailed crosswalks from the <a href="https://esubmission.ecpa.eu/toc/EU">EU Table of Contents (SANCO/10181/2013)</a> for microbial plant protection product (PPP) dossiers to <a href="https://iuclid6.echa.europa.eu/">IUCLID 6.6</a>. 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):</p> <ul> <li><strong>EU_PPP_Micro_ActiveSubstance</strong>: mapping between the "KMA" ToC and IUCLID 6.5's working context "EU PPP Microorganisms - active substance information"</li> <li><strong>EU_PPP_Micro_Product</strong>: mapping between the "KMP" ToC and IUCLID 6.5's working context "EU PPP Microorganisms - active substance application (product)"</li> </ul> <p>The spreadsheets map each section of the original EU ToC to:</p> <ul> <li><strong><em>IUCLID section</em></strong>: name of the section in IUCLID where to input the corresponding data/information</li> <li><em><strong>Endpoint study record</strong></em>: name of the document template used to report individual studies of the section (if exists). These usually correspond to OECD Harmonised Templates (OHT).</li> <li><em><strong>Endpoint summary</strong></em>: name of the document template used to report the summary information of the studies presented in the section (if exists)</li> <li><em><strong>Other IUCLID document</strong></em>: name of any other document template in IUCLID used to report information of the section (if exists)</li> <li><em><strong>OHT</strong>:</em> name/id of the OECD Harmonised Template used for the endpoint study record document (if exists)</li> <li><em><strong>Additional context</strong></em>: 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.</li> </ul> <p><strong>Version 3 </strong>includes changes in the table of contents of IUCLID6.6.</p>
Running the validation assistant tool on pesticide dossiers in IUCLID
<p>Before submitting a dossier, <strong>applicants</strong> are recommended to use the Validation Assistant tool to check the dossier is technically complete. It is important to resolve all validation assistant quality warnings as this will support the Admissibility Check of the RMS/EMS. The <strong>RMS/EMS</strong> should also run the validation assistant report before declaring the admissibility of a dossier to make sure the dossier is complete.</p> <p>If the report shows a business rule failure (anything starting with BR, e.g. BR_PPP_033) this will prevent the applicant from successfully submitting the dossier and therefore must be resolved.</p> <p>This demonstration is supporting RMS/EMS and applicants on how to run the validation assistant tool and extract the report. </p>
IUCLID videos on most common mistakes (parts 1 & 2)
<p>The 12 videos and a high-level description of the content are listed below.</p> <p><strong>1. Attachments and sanitisation</strong></p> <p>Add attachments to the literature reference entity:</p> <ul> <li>Study report</li> <li>MSS composer file</li> <li>Scientific publication including a citation in the sanitised attachment field</li> </ul> <p>Add attachments to a Flexible Summary – Primo model excel file</p> <p>Check the size and sanitisation in the attachments report</p> <p><strong>2. Components of an Active Substance Dossier</strong></p> <p>How to add the different datasests that make up a IUCLID dossier:</p> <p>Complete the mixture composition document:</p> <ul> <li>“Detailed quantitative and qualitative information on the composition of the plant protection product”</li> <li>“Information on the active substance/s”</li> <li>“Information on safeners, synergists and co-formulants”</li> </ul> <p>Complete the flexible summary Metabolite – “Information on metabolites”</p> <p>Complete the fixed record “Other Representative Products” </p> <p>3. <strong>Analytical profile of batches</strong></p> <p>How to report the Analytical Profile of Batches</p> <p>Complete the substance composition document</p> <ul> <li>Active substance – to be reported in section “Constituents”</li> <li>Impurities</li> <li>Additives</li> </ul> <p>Complete the endpoint summary Analytical Profile of Batches</p> <p>Check presentation of the 5-batch analysis in Document M Section 1 (Identity)</p> <p><strong>4. How the dossier is published and what an applicant should do before submission</strong></p> <p>EFSA must publish the dossier “as submitted by the applicant” after it has been declared admissible by the RMS/EMS à Submit a dossier which can be published without risking disclosure of confidential or personal data</p> <p>Confidential data</p> <ul> <li>Check the filter rules when preparing the dossier</li> <li>Run dissemination preview before submitting</li> <li>Check the critical elements in the excel file</li> </ul> <p>Personal data</p> <ul> <li>Double-check relevant parts of the dossier (sanitised attachments in particular)</li> <li>Find a dossier from OpenEFSA once it has been published</li> </ul> <p><strong>5. Validation rules</strong></p> <p>Use validation assistant before submitting to check the dossier is technically complete</p> <ul> <li>Resolve all business rules so that the dossier is not blocked in the submission portal</li> <li>Resolve all validation assistant warnings</li> <li>If a warning cannot be resolved provide justification in the validation assistant excel report to the RMS but this may result in a request for a dossier update and resubmission</li> </ul> <p><strong>6. Further information section completing the document</strong></p> <p>How to complete Section 3 of the active substance ToC – “Further information on the active substance”</p> <ul> <li>Complete the endpoint study record “Effectiveness against target organisms” – section 3.2</li> <li>Complete the endpoint summary “Effectiveness against target organisms” – section 3</li> <li>Complete the flexible record “Protection measures” – section 3.3</li> </ul> <p>These instructions also apply to the documents in the Product dataset</p> <p><strong>7. Completing the flexible summaries in the residues section</strong></p> <p> </p> <p>Complete the endpoint summary of Stability of residues in stored commodities – section 6.1</p> <ul> <li>Complete the <strong>endpoint summary</strong> metabolism of residues in plants and rotational crops –section 6.2.1 </li> <li>Complete the <strong>endpoint summary</strong> metabolism of residues in livestock –section 6.2.2</li> <li>Complete the <strong>endpoint summary</strong> magnitude of residues in plants –section 6.3 </li> <li>Complete the <strong>flexible summary</strong> “Feeding studies” – section 6.4</li> <li>Complete the <strong>endpoint summary</strong> Nature and Magnitude of residues in processed commodities 6.5 </li> <li>Complete the <strong>flexible summary</strong> “Proposed residue definitions” – section 6.7.1</li> <li>Complete the<strong> flexible summary</strong> “Proposed maximum residue levels” – section 6.7.2</li> <li>Complete the<strong> flexible summary</strong> “Estimation of the potential and actual exposure through diet and other sources” – section 6.9</li> </ul> <p><strong>8. Legal Entity</strong></p> <p>Use of legal entities in PPP dossiers and in the Submission Portal</p> <ul> <li>What is a Legal Entity</li> <li>Where are legal entities are used in the dossier</li> <li>The role of Legal entities in the submission Portal</li> </ul> <p><strong>9. Requesting confidential treatment</strong></p> <ul> <li>Clear identification of the information claimed confidential and its location</li> <li>Identification of the legal basis of the request</li> <li>Submission of a compliant justification for the request</li> </ul> <p><strong>10. Analytical methods </strong>(also for Section 5 of the Product dataset)</p> <ul> <li>How to complete the Endpoint Study Record “Analytical methods”</li> <li>How to cross-reference the analytical methods in the corresponding studies</li> <li>How to generate Document M – Section 4 (Analytical methods) using Report Generator</li> </ul> <p><strong>11. Assessment by other authorities</strong></p> <p>The document is in the summary and evaluation section</p> <ul> <li>How to report information on Assessments in Europe and Assessments Outside Europe</li> <li>How to report information on existing MRLs</li> <li>How to provide additional information ONLY for Import Tolerance applications</li> </ul> <p><strong>12. Dossier submission</strong></p> <ul> <li>Ensure that all the pre-submission checks are carried out to enable a successful submission</li> <li>Create and export a dossier</li> <li>Submit a dossier</li> <li>Successfully re-submit a dossier</li> </ul>
IUCLID training on common mistakes (parts 1 & 2)
<p>Based on a preliminary analysis of the submissions received so far, EFSA has been able to identify a number of frequent mistakes across pesticide dossiers submitted in IUCLID and the aim of this training is to provide a brief outline of both the problem and the solution in order to support applicants in preventing similar issues from occurring in future submissions.</p> <p><strong>Topics covered:</strong></p> <p><strong>Part 1</strong></p> <p>1. Attachments and Sanitisation - based on Attachments text in the manual and strong focus on applicant role for study reports</p> <p>2. Components of an Active Substance dossier</p> <p>3. Analytical profile of batches</p> <p>4. How the dossier is published and what an applicant should do before submission</p> <p>5. Validation rules</p> <p>6. Further information section completing the document</p> <p><strong>Part 2</strong></p> <p>7. Completing flexible summaries in the residues section</p> <p>8. Legal entity</p> <p>9. Requesting confidential treatment</p> <p>10. Analytical methods</p> <p>11. Assessment by other authorities</p> <p>12. Dossier submission</p> <p>Each tutorial is followed by a Q&A session. The videos will also be made available separately.</p> <p>N.B. Please note that the Part 1 video recording is split in two (A & B) due to technical issues.</p>
IUCLID for public consultations
<p>The video describes how to participate in the public consultation on a pesticide dossier and how to browse the studies in a IUCLID dossier.</p> <p>It provides a high-level description of the following:</p> <ul> <li>the transparency regulation</li> <li>the steps in the authorisation process</li> <li>the requirement for standard data formats</li> <li>information about the IUCLID format & OECD harmonised templates, which are used globally</li> <li>how a dossier is prepared for the public consultation</li> <li>Open EFSA Portal and how the find substances and dossiers of interest</li> <li>finding and opening dossiers in PUBLIC IUCLID</li> <li>how to view the product dataset and the substance dataset</li> <li>how to view scientific studies in an endpoint study records and endpoint summaries</li> <li>how to create a PDF of a study of interest</li> <li>how to report your comments in the public consultation</li> <li>how to review all the comments in a closed public consultation</li> </ul>
IUCLID for pesticides filtering rule proposal for April 2024
<p>These are the draft filtering rules for pesticides dossiers in IUCLID proposed for implementation as from April 2024. The proposal is made by EFSA with the endorsement of the IUCLID PSN sub-group. These rules are up for public consultation until 20 September and any feedback can be provided through EU Survey where more details on the proposal can also be found: <a href="https://ec.europa.eu/eusurvey/runner/bae82a4d-e924-67e4-59fc-b1f3bcfdedb5">https://ec.europa.eu/eusurvey/runner/bae82a4d-e924-67e4-59fc-b1f3bcfdedb5</a></p>
Light check for personal data on pesticide dossiers in IUCLID
<p>In order to comply with the proactive disclosure requirements set out in Article 38 of Regulation (EC) No 178/2002, <strong>it is first and foremost the applicant’s responsibility</strong> to submit a non-confidential version of an application dossier. Disclosure of personal data is then a joint responsibility shared between the applicant, the Rapporteur Member State/Evaluating Member State and EFSA.</p> <p>Currently, upon declaration of admissibility by the RMS/EMS and in preparation of the dossier for publication, EFSA performs a “light check” with the aim of identifying issues in relation to personal data and to verify whether redaction has been performed in irreversible manner, in order to avoid that such data are released upon publication.</p> <p>Ideally the RMS/EMS should implement a comparable "light check” in the context of the admissibility check, so that any issues in relation to confidential/personal data may be addressed by the applicant prior to declaring the dossier admissible. This is expected to contribute to a timely publication of the dossier.</p> <p>This video shows the light check carried out in practice.</p> <p>Applicants should always remember to run the Dissemination preview and generate the filtered dossier <strong>before</strong> submitting to check what will be published.</p>
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