{"id":6863,"date":"2023-10-26T07:10:38","date_gmt":"2023-10-26T07:10:38","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=6863"},"modified":"2023-10-27T07:20:29","modified_gmt":"2023-10-27T07:20:29","slug":"europe-com-update-of-gd-sanco-6895-2009-rev-3-drr-templates-micro-organisms","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-com-update-of-gd-sanco-6895-2009-rev-3-drr-templates-micro-organisms\/","title":{"rendered":"EUROPE &#8211; COM : Update of GD SANCO\/6895\/2009 rev 3 \u2013 dRR templates micro-organisms"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The European Commission has published on 12 October 2023 <\/span><b>an update of SANCO\/6895\/2009<\/b><span style=\"font-weight: 400\">. This 3rd version updates version rev 2.2 of January 2018.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">This revision includes <\/span><b>new draft registration report (dRR) templates <\/b><span style=\"font-weight: 400\">for plant protection products (PPP) containing active substances which are <\/span><b>micro-organisms<\/b><span style=\"font-weight: 400\">. This update aligns the dRR with the new requirements introduced by<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022R1440\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\"> Regulation (EU) 2022\/1440<\/span><\/a><span style=\"font-weight: 400\">, as regards the information to be submitted for plant protection products and the specific data requirements for PPP containing micro-organisms, and <\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022R1441&amp;qid=1698315179024\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Regulation (EU) 2022\/1441<\/span><\/a><span style=\"font-weight: 400\">, as regards specific uniform principles for evaluation and authorisation of PPP containing micro-organisms. These two regulations are applicable from 21 November 2022.\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Furthermore, a dedicated section to the use of the weight-of-evidence approach in the risk assessment of micro-organisms has been introduced in the dRR, parts B.1, B.2 and B.4. In addition, the risk assessment of metabolites of concern has been included in the part of the dRR dealing with the risk assessment of micro-organisms.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The new dRR templates will come into force on <\/span><b>21 November 2024<\/b><span style=\"font-weight: 400\">. Before this date, the former templates remain applicable for marketing authorisation submitted in accordance with Regulation (EU) No 284\/2013 as it stood before being amended by Regulation (EU) 2022\/1440. For marketing authorisation submitted in accordance with Reg (EU) No 284\/2013 as amended by Reg (EU) 2022\/1440, the new dRR\u00a0 templates are applicable.<\/span><\/p>\n<p><span style=\"font-weight: 400\">\u00a0<\/span><\/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\/system\/files\/2023-10\/pesticides_ppp_app-proc_guide_doss_reg-report-tech-guidelines_v3-2023.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">SANCO\/6895\/2009 rev 3 \u2013 Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400\">\u00a0<\/span><\/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-update-of-gd-sanco68952009-rev-2-2-drr-format\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">EUROPE: Update of GD SANCO\/6895\/2009 rev 2.2 \u2013 dRR format<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400\">\u00a0<\/span><\/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<h6><\/h6>\n<p>&nbsp;<\/p>\n<h6><span style=\"font-weight: 400\"><\/p>\n<p>Photo credit: \u00a0stux\/pixabay<\/span><\/h6>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has published on 12 October 2023 an update of SANCO\/6895\/2009. This 3rd version updates version rev 2.2 of January 2018. This revision includes<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":11,"featured_media":6861,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[404,74,488],"class_list":["post-6863","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-commission-en","tag-drr-en","tag-micro-organism"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUROPE - COM : Update of GD SANCO\/6895\/2009 rev 3 \u2013 dRR templates micro-organisms - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"The European Commission has published on 12 October 2023 an update of SANCO\/6895\/2009. This 3rd version updates version rev 2.2 of January 2018. This\" \/>\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-gd-sanco-6895-2009-rev-3-drr-templates-micro-organisms\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUROPE - COM : Update of GD SANCO\/6895\/2009 rev 3 \u2013 dRR templates micro-organisms - Lynxee consulting\" \/>\n<meta property=\"og:description\" content=\"The European Commission has published on 12 October 2023 an update of SANCO\/6895\/2009. This 3rd version updates version rev 2.2 of January 2018. 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