{"id":8685,"date":"2026-01-27T07:27:48","date_gmt":"2026-01-27T07:27:48","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=8685"},"modified":"2026-02-05T04:54:12","modified_gmt":"2026-02-05T04:54:12","slug":"europe-com-update-of-the-guidance-document-on-the-evaluation-of-new-active-substance-data-post-approval","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-com-update-of-the-guidance-document-on-the-evaluation-of-new-active-substance-data-post-approval\/","title":{"rendered":"EUROPE \u2013 COM: Update of the guidance document on the evaluation of new active substance data post-approval"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The European Commission has published an update to guidance document <\/span><b>SANCO 10328\/2004<\/b><span style=\"font-weight: 400\"> on the evaluation of new active substance data submitted after (renewal of) approval. This 10th version incorporates the conclusions from the ZAPID (Zonal Authorisation Procedure Improvements and Developments) workshop held in December 2023. The main changes are outlined below.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">This new version:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">updates the evaluation process for new active substance data submitted within a PPP dossier that require assessment prior to the renewal of the active substance. Where identical data are submitted in several zones, an izRMS is appointed to evaluate these data on behalf of all concerned zRMSs to avoid duplication of effort;<\/span><\/li>\n<\/ul>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">reaffirms that any change to toxicological reference values (TRVs) or residue definitions must be evaluated at the EU level;<\/span><\/li>\n<\/ul>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">specifies that the handling of &#8220;data gaps&#8221; identified by EFSA\u2014if not required to finalise a product authorisation\u2014is postponed until the next renewal of the active substance;<\/span><\/li>\n<\/ul>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">adds detailed annexes on the management of data gaps from EFSA conclusions (Annex 1) and a flowchart of the zonal evaluation process (Annex 3); and<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;text-align: justify\"><span style=\"font-weight: 400\">enhances transparency with a centralised list of new active substance data currently under evaluation, downloadable from CIRCABC.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The document <\/span><b>applies from 21 January 2026<\/b><span style=\"font-weight: 400\">.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/food.ec.europa.eu\/document\/download\/b5067c4c-a800-4cd2-aa94-917cd56a8f0a_en\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Guidance document on the evaluation of new active substance data post (renewal of) approval (SANCO\/10328\/2004 \u2013 Rev 10)<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>See also our previous articles:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/lynxee.consulting\/en\/europe-com-update-of-guidance-documents-on-new-active-substance-data-post-approval-on-rules-for-revision-of-assessment-reports-and-on-data-matching\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">EUROPE \u2013 COM : Update of guidance documents on new active substance data post approval, on rules for revision of assessment reports and on data matching<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>Lynxee consulting<\/b><span style=\"font-weight: 400\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Contact us!<\/b> <a href=\"http:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">http:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<h6 style=\"text-align: justify\"><span style=\"font-weight: 400\">Photo credit:<\/span><span style=\"font-weight: 400\"> Reiseblogger\/pixabay<\/span><\/h6>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has published an update to guidance document SANCO 10328\/2004 on the evaluation of new active substance data submitted after (renewal of) approval. This<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":11,"featured_media":8682,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[392,671,669,670],"class_list":["post-8685","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-active-substance","tag-data-gap","tag-post-approval","tag-sanco-10328-2004"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPE \u2013 COM: Update of the guidance document on the evaluation of new active substance data post-approval - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"The European Commission has published an update to guidance document SANCO 10328\/2004 on the evaluation of new active substance data submitted after\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lynxee.consulting\/en\/europe-com-update-of-the-guidance-document-on-the-evaluation-of-new-active-substance-data-post-approval\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUROPE \u2013 COM: Update of the guidance document on the evaluation of new active substance data post-approval - 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