{"id":9189,"date":"2019-06-20T14:50:50","date_gmt":"2019-06-20T12:50:50","guid":{"rendered":"http:\/\/www.phytocontrol.com\/?p=9189"},"modified":"2026-08-28T00:50:48","modified_gmt":"2026-08-27T22:50:48","slug":"summary-of-sanco-3030-rev5","status":"publish","type":"post","link":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/","title":{"rendered":"Summary of SANCO 3030 rev5"},"content":{"rendered":"

SANCO\/3030\/99 rev.5
\n<\/strong>“Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283\/2013 and Annex (Section 5) of Regulation (EU) No 284\/2013”.<\/p>\n

New version of the guidance (rev.5) published on 22 March 2019
\nApplicable from 1 October 2019<\/strong><\/p>\n

Compared with the previous version (rev.4), the changes consist of a general update of the guidance in line with the document developments of Regulation (EU) No. 283\/2013 and 284\/2013. These regulations establish the data requirements for active substances and plant protection products.<\/p>\n

    \n
  1. Scope<\/strong><\/li>\n<\/ol>\n

    The SANCO guidance provides guidelines on the requirements for analytical methods for chemical and plant protection products associated with pre-registration and registration applications for active substances or technical active substances. These applications are governed by Regulation (EC) No 1107\/2009.<\/p>\n

      \n
    1. Synthetic summary of SANCO\/3030\/99 (rev.5)<\/strong><\/li>\n<\/ol>\n

      The SANCO guidance contains information on the scope and applicability of analytical methods associated with registration applications (pre-, post- and monitoring). It governs the use of chemical derivatisation when the properties of the target analyte are not compatible with the analytical procedure. This framework includes a set of analytical requirements and elements to be demonstrated, in particular the specificity of the derivatised species for the analyte of interest. In the specific case of a non-specific derivatised species (i.e. when the derivative formed is common to two active substances\/impurities\/co-formulants), the method is considered non-specific and its use is strongly discouraged.<\/p>\n

      The guidance also specifies the method validation criteria for the analysis of technical active substances or plant protection products. In both cases, this includes the determination of the active substance, impurities or additives\/co-formulants. For technical active substances, confirmation of the analyte’s identity is required for a pre-registration application. This confirmation may be part of the method validation. In the case of plant protection products, confirmation of the identity of impurities is required as part of method validation. This can be addressed using a highly specific method or a confirmatory method (e.g. using two transitions or one transition with several fragments representative of the substance in LC or GC-MS\/MS).<\/p>\n

        \n
      1. Impact on the GLP framework<\/strong><\/li>\n<\/ol>\n

        The compliance requirements in the GLP framework for the validation of analytical methods in support of registration applications carried out under Regulation (EC) No 1107\/2009 are detailed in Directive 2004\/10\/EC and referenced in Regulation (EC) 1107\/2009, Article 3(19). The development and validation of a method are not within the scope of GLP. However, when a method is used to generate data for safety purposes, for example when the active substance degrades into (eco)toxicologically active products, these studies must be conducted within a GLP framework.<\/p>\n","protected":false},"excerpt":{"rendered":"

        SANCO\/3030\/99 rev.5 “Technical Active Substance and Plant protection products: Guidance for generating and reporting methods…<\/p>\n","protected":false},"author":8,"featured_media":9178,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[],"class_list":["post-9189","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-watch"],"acf":[],"yoast_head":"\nSummary of SANCO 3030 rev5 - Phytocontrol<\/title>\n<meta name=\"description\" content=\"Summary of guidance SANCO\/3030\/99 rev.5 on analytical methods for active substances and plant protection products, published 22 March 2019.\" \/>\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=\"Summary of SANCO 3030 rev5\" \/>\n<meta property=\"og:description\" content=\"Summary of guidance SANCO\/3030\/99 rev.5 on analytical methods for active substances and plant protection products, published 22 March 2019.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/\" \/>\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=\"2019-06-20T12:50:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-27T22:50:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/SANCO.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\\\/summary-of-sanco-3030-rev5\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/\"},\"author\":{\"name\":\"L\u00e9a\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/#\\\/schema\\\/person\\\/b6615d9f6255172ec54877731e3b62a5\"},\"headline\":\"Summary of SANCO 3030 rev5\",\"datePublished\":\"2019-06-20T12:50:50+00:00\",\"dateModified\":\"2026-08-27T22:50:48+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/\"},\"wordCount\":440,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dev.phytocontrol.com\\\/app\\\/uploads\\\/2019\\\/06\\\/SANCO.png\",\"articleSection\":[\"Regulatory watch\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/\",\"url\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/\",\"name\":\"Summary of SANCO 3030 rev5 - Phytocontrol\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dev.phytocontrol.com\\\/app\\\/uploads\\\/2019\\\/06\\\/SANCO.png\",\"datePublished\":\"2019-06-20T12:50:50+00:00\",\"dateModified\":\"2026-08-27T22:50:48+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/#\\\/schema\\\/person\\\/b6615d9f6255172ec54877731e3b62a5\"},\"description\":\"Summary of guidance SANCO\\\/3030\\\/99 rev.5 on analytical methods for active substances and plant protection products, published 22 March 2019.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#primaryimage\",\"url\":\"https:\\\/\\\/dev.phytocontrol.com\\\/app\\\/uploads\\\/2019\\\/06\\\/SANCO.png\",\"contentUrl\":\"https:\\\/\\\/dev.phytocontrol.com\\\/app\\\/uploads\\\/2019\\\/06\\\/SANCO.png\",\"width\":700,\"height\":400,\"caption\":\"R\u00e9sum\u00e9 de la SANCO 3030 rev5\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/regulatory-watch\\\/summary-of-sanco-3030-rev5\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Summary of SANCO 3030 rev5\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/\",\"name\":\"Phytocontrol\",\"description\":\"Laboratoire d'analyses\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/dev.phytocontrol.com\\\/en\\\/#\\\/schema\\\/person\\\/b6615d9f6255172ec54877731e3b62a5\",\"name\":\"L\u00e9a\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/596dd8ddc5587d4fa6d385b3be7df83487233933b2a48701410e4262697bd00a?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/596dd8ddc5587d4fa6d385b3be7df83487233933b2a48701410e4262697bd00a?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/596dd8ddc5587d4fa6d385b3be7df83487233933b2a48701410e4262697bd00a?s=96&d=mm&r=g\",\"caption\":\"L\u00e9a\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Summary of SANCO 3030 rev5 - Phytocontrol","description":"Summary of guidance SANCO\/3030\/99 rev.5 on analytical methods for active substances and plant protection products, published 22 March 2019.","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"en_US","og_type":"article","og_title":"Summary of SANCO 3030 rev5","og_description":"Summary of guidance SANCO\/3030\/99 rev.5 on analytical methods for active substances and plant protection products, published 22 March 2019.","og_url":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/","og_site_name":"Phytocontrol","article_publisher":"https:\/\/www.facebook.com\/laboratoirePHYTOCONTROL","article_published_time":"2019-06-20T12:50:50+00:00","article_modified_time":"2026-08-27T22:50:48+00:00","og_image":[{"width":700,"height":400,"url":"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/SANCO.png","type":"image\/png"}],"author":"L\u00e9a","twitter_card":"summary_large_image","twitter_misc":{"Written by":"L\u00e9a","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#article","isPartOf":{"@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/"},"author":{"name":"L\u00e9a","@id":"https:\/\/dev.phytocontrol.com\/en\/#\/schema\/person\/b6615d9f6255172ec54877731e3b62a5"},"headline":"Summary of SANCO 3030 rev5","datePublished":"2019-06-20T12:50:50+00:00","dateModified":"2026-08-27T22:50:48+00:00","mainEntityOfPage":{"@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/"},"wordCount":440,"commentCount":0,"image":{"@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#primaryimage"},"thumbnailUrl":"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/SANCO.png","articleSection":["Regulatory watch"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/","url":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/","name":"Summary of SANCO 3030 rev5 - Phytocontrol","isPartOf":{"@id":"https:\/\/dev.phytocontrol.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#primaryimage"},"image":{"@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#primaryimage"},"thumbnailUrl":"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/SANCO.png","datePublished":"2019-06-20T12:50:50+00:00","dateModified":"2026-08-27T22:50:48+00:00","author":{"@id":"https:\/\/dev.phytocontrol.com\/en\/#\/schema\/person\/b6615d9f6255172ec54877731e3b62a5"},"description":"Summary of guidance SANCO\/3030\/99 rev.5 on analytical methods for active substances and plant protection products, published 22 March 2019.","breadcrumb":{"@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#primaryimage","url":"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/SANCO.png","contentUrl":"https:\/\/dev.phytocontrol.com\/app\/uploads\/2019\/06\/SANCO.png","width":700,"height":400,"caption":"R\u00e9sum\u00e9 de la SANCO 3030 rev5"},{"@type":"BreadcrumbList","@id":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/summary-of-sanco-3030-rev5\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/dev.phytocontrol.com\/en\/"},{"@type":"ListItem","position":2,"name":"Summary of SANCO 3030 rev5"}]},{"@type":"WebSite","@id":"https:\/\/dev.phytocontrol.com\/en\/#website","url":"https:\/\/dev.phytocontrol.com\/en\/","name":"Phytocontrol","description":"Laboratoire d'analyses","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/dev.phytocontrol.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/dev.phytocontrol.com\/en\/#\/schema\/person\/b6615d9f6255172ec54877731e3b62a5","name":"L\u00e9a","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/596dd8ddc5587d4fa6d385b3be7df83487233933b2a48701410e4262697bd00a?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/596dd8ddc5587d4fa6d385b3be7df83487233933b2a48701410e4262697bd00a?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/596dd8ddc5587d4fa6d385b3be7df83487233933b2a48701410e4262697bd00a?s=96&d=mm&r=g","caption":"L\u00e9a"}}]}},"_links":{"self":[{"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/posts\/9189","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/comments?post=9189"}],"version-history":[{"count":1,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/posts\/9189\/revisions"}],"predecessor-version":[{"id":546029,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/posts\/9189\/revisions\/546029"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/media\/9178"}],"wp:attachment":[{"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/media?parent=9189"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/categories?post=9189"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.phytocontrol.com\/en\/wp-json\/wp\/v2\/tags?post=9189"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}