{"id":3369,"date":"2019-04-30T13:40:23","date_gmt":"2019-04-30T13:40:23","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=3369"},"modified":"2024-11-20T10:54:29","modified_gmt":"2024-11-20T10:54:29","slug":"europe-com-guidances-update-on-active-substance-applications-for-approbation-and-renewal","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-com-guidances-update-on-active-substance-applications-for-approbation-and-renewal\/","title":{"rendered":"EUROPE &#8211; COM: Guidances update on active substance applications for approbation and renewal"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Further to the publication of EFSA \u201cAdministrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances\u201d, several SANCO Guidance documents have been updated to ensure consistency:<\/span><\/p>\n<p style=\"text-align: justify;\">\n<p style=\"text-align: justify;\"><a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_ppp_app-proc_guide_pai_11251.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">SANCO\/2012\/11251 rev. 5<\/span><\/a><span style=\"font-weight: 400;\"> (22 March 2019) &#8211; DRAFT Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844\/2012 (the Renewal Regulation) <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Changes were made to provide updates to process and clarifications on certain elements related to the renewal process.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Entry into force: for applications for renewal of approval submitted after 1 April 2019.<\/span><\/p>\n<p style=\"text-align: justify;\">\n<p style=\"text-align: justify;\"><a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_ppp_app-proc_guide_doss_12580.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">SANCO\/12580\/2012- rev. 4<\/span><\/a><span style=\"font-weight: 400;\"> (22 March 2019) &#8211; Guidance document on preparing lists of test and study reports according to Article 60 of Regulation (EC) No 1107\/2009<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The format for lists of studies has been updated to ensure that it is indicated whether a study was used in a previous EU assessment or, when the information is available, whether the study was already submitted in the framework of National authorisations.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Entry into force: for (supplementary) dossiers submitted on or after 1 October 2019.<\/span><\/p>\n<p style=\"text-align: justify;\">\n<p style=\"text-align: justify;\"><a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_ppp_app-proc_guide_doss_10181.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">SANCO\/10181\/2013- rev. 4<\/span><\/a><span style=\"font-weight: 400;\"> (22 March 2019) &#8211; Guidance for applicants on preparing dossiers for the approval of a chemical new active substance and for the renewal of approval of a chemical active substance according to Regulation (EU) No 283\/2013 and Regulation (EU) 284\/2013<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The special case of the non-submission of particular studies required by the EU legislation has been amended.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Entry into force: for (supplementary) dossiers submitted on or after 1 October 2019.<\/span><\/p>\n<p style=\"text-align: justify;\">\n<p style=\"text-align: justify;\"><a href=\"https:\/\/ec.europa.eu\/food\/sites\/food\/files\/plant\/docs\/pesticides_ppp_app-proc_guide_doss_12592-2012.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">SANCO\/12592\/2012- rev.2<\/span><\/a><span style=\"font-weight: 400;\"> (22 March 2019) &#8211; Combined Template to be used for Assessment Reports according to Regulation (EC) No 1107\/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272\/2008<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Updates were made to add a statement to each section cover page to explain how information is presented, to amend the sections in Volume 1 where the summary of the assessment of endocrine disrupting properties is made, and to revise the format of the table of lists of tests and studies.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Entry into force: For Assessment Reports submitted by MS to EFSA from 1 April 2019 as a minimum the revised Volume 1 should be used and the statement should be added to each section cover page. The revised templates are fully applicable for dossiers submitted from 1 April 2019.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>See also our previous articles: <\/b><\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/lynxee.consulting\/en\/europe-efsa-guidance-on-active-substance-applications-for-approbation-and-renewal\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">EUROPE &#8211; EFSA : Guidance on active substance applications for approbation and renewal<\/span><\/a><\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/lynxee.consulting\/en\/europe-combined-template-to-be-used-assessment-reports-proposals-classification\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">EUROPE: Combined template to be used for assessment reports and proposals for classification<\/span> <\/a><\/p>\n<p>&nbsp;<\/p>\n<p><b>Lynxee consulting<\/b><span style=\"font-weight: 400;\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p><b>Contact us!<\/b> <a href=\"https:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">https:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h6>Photo credit: Uki_71\/pixabay<\/h6>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Further to the publication of EFSA \u201cAdministrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances\u201d, several SANCO Guidance documents<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":4,"featured_media":3357,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[164],"class_list":["post-3369","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-document-guide-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUROPE - COM: Guidances update on active substance applications for approbation and renewal - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"Further to the publication of EFSA \u201cAdministrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active\" \/>\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-guidances-update-on-active-substance-applications-for-approbation-and-renewal\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUROPE - COM: Guidances update on active substance applications for approbation and renewal - Lynxee consulting\" \/>\n<meta property=\"og:description\" content=\"Further to the publication of EFSA \u201cAdministrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active\" \/>\n<meta property=\"og:url\" content=\"https:\/\/lynxee.consulting\/en\/europe-com-guidances-update-on-active-substance-applications-for-approbation-and-renewal\/\" \/>\n<meta property=\"og:site_name\" content=\"Lynxee consulting\" \/>\n<meta property=\"article:published_time\" content=\"2019-04-30T13:40:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-20T10:54:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2019\/05\/tomato-3466644_1920.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1280\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"\u00c9milie Vianay\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u00c9milie Vianay\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/lynxee.consulting\\\/en\\\/europe-com-guidances-update-on-active-substance-applications-for-approbation-and-renewal\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/lynxee.consulting\\\/en\\\/europe-com-guidances-update-on-active-substance-applications-for-approbation-and-renewal\\\/\"},\"author\":{\"name\":\"\u00c9milie Vianay\",\"@id\":\"https:\\\/\\\/lynxee.consulting\\\/#\\\/schema\\\/person\\\/4e2e7b2258dcb671ad7fbafa59128a5d\"},\"headline\":\"EUROPE &#8211; 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