{"id":9187,"date":"2019-06-14T14:46:21","date_gmt":"2019-06-14T12:46:21","guid":{"rendered":"http:\/\/www.phytocontrol.com\/?p=9187"},"modified":"2026-08-28T00:50:56","modified_gmt":"2026-08-27T22:50:56","slug":"efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances","status":"publish","type":"post","link":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\/","title":{"rendered":"EFSA technical report on issues related to the risk assessment of active substances"},"content":{"rendered":"<p>On 23 April 2019, EFSA published a technical report following an expert meeting on recurring issues encountered when assessing the risks of active substances under Regulation (EC) No 1107\/2009.<\/p>\n<p>These topics were discussed at the general assembly held from 14 to 16 November 2019 with experts from the various national authorities, with the aim of strengthening the harmonisation of risk assessment.<\/p>\n<p>The main issues identified were related to the quality and level of detail of assessment reports and compliance with data requirements.<br \/>\nThe experts&#8217; decisions and\/or opinions are presented in this technical report.<br \/>\nThese recommendations will be applied during EFSA&#8217;s peer review of active substances and should provide further clarification to applicants and rapporteur Member States regarding the scientific interpretation of the relevant guidance documents when preparing dossiers and draft assessment\/renewal reports.<\/p>\n<p>The report covers the following points:<\/p>\n<ul>\n<li>CRD (Chemicals Regulation Division) guidance on physical and chemical properties, for which the experts call for further harmonisation. In particular, on the accepted methods for physical hazards, the need for long-term storage stability data before authorisation in the northern zone, the need to conduct GLP studies, and the inclusion of a CAS (Chemical Abstracts Service) statement for tank mixtures.<\/li>\n<li>Physico-chemical properties of the active substance and the PPP: cases where several studies address the same endpoint, studies submitted by a task force, re-evaluation of previously accepted physico-chemical studies, oxidising properties, acceptability of physico-chemical studies carried out before July 1993, i.e. not under GLP<\/li>\n<li>Revision of guidance documents: Guides SANCO\/3030\/99, SANCO\/3029\/99 and SANCO\/825\/00<\/li>\n<li>Methods used to generate pre-approval data (Regulation (EU) 283\/2013): Method evaluation and method report<\/li>\n<li>Methods for monitoring body fluids and tissues<\/li>\n<li>Evaluation of extraction efficiency in residue analysis methods<\/li>\n<li>Isomeric composition<\/li>\n<li>Relevance of impurities<\/li>\n<li>Analysis of five representative batches from recent and current industrial-scale production of the active substance, to determine the content of pure active substance, impurities, additives and each additional component other than additives, as applicable.<\/li>\n<li>Confirmation of analyte identification (active substance, relevant and significant impurities)<\/li>\n<li>LOQ for relevant and significant impurities &#8211; 5-batch analysis<\/li>\n<li>Cases of impurities detected but not quantified in some batches but quantified in others<\/li>\n<li>Specifications: Minimum purity, identification of substances of natural origin, changes to technical specifications upon renewal, equivalence after renewal, co-formulants as active substances, composition of a PPP where variants of the active substance form during formulation<\/li>\n<li>Micro-organisms: Identification, stability and analytical methods<\/li>\n<\/ul>\n<p>You will find the full report at the link below:<br \/>\n<a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/epdf\/10.2903\/sp.efsa.2019.EN-1623\">Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods<\/a><\/p>\n<p>Recognised as GLP-compliant by the GIPC, Phytocontrol BioPharma supports you in your analytical projects.<\/p>\n<p>Please <a href=\"https:\/\/www.phytocontrol.com\/acces-contact-phytocontrol\/\">contact us<\/a> to discuss your needs. Phytocontrol will put its scientific expertise at your service.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 23 April 2019, EFSA published a technical report following an expert meeting on recurring&hellip;<\/p>\n","protected":false},"author":8,"featured_media":9177,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[],"class_list":["post-9187","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-watch"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EFSA technical report on issues related to the risk assessment of active substances - Phytocontrol<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EFSA technical report on issues related to the risk assessment of active substances\" \/>\n<meta property=\"og:description\" content=\"On 23 April 2019, EFSA published a technical report following an expert meeting on recurring&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\/\" \/>\n<meta property=\"og:site_name\" content=\"Phytocontrol\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/laboratoirePHYTOCONTROL\" \/>\n<meta property=\"article:published_time\" content=\"2019-06-14T12:46:21+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-27T22:50:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/EFSA.png\" \/>\n\t<meta property=\"og:image:width\" content=\"700\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"L\u00e9a\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"L\u00e9a\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/\"},\"author\":{\"name\":\"L\u00e9a\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/#\\\/schema\\\/person\\\/b6615d9f6255172ec54877731e3b62a5\"},\"headline\":\"EFSA technical report on issues related to the risk assessment of active substances\",\"datePublished\":\"2019-06-14T12:46:21+00:00\",\"dateModified\":\"2026-08-27T22:50:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/\"},\"wordCount\":460,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dev.phytocontrol.com\\\/app\\\/uploads\\\/2019\\\/06\\\/EFSA.png\",\"articleSection\":[\"Regulatory watch\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/\",\"url\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/efsa-technical-report-on-issues-related-to-the-risk-assessment-of-active-substances\\\/\",\"name\":\"EFSA technical report on issues related to the risk assessment of active substances - 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