{"id":5323,"date":"2023-07-13T08:30:52","date_gmt":"2023-07-13T06:30:52","guid":{"rendered":"https:\/\/amoeba-nature.com\/?p=5323"},"modified":"2023-07-13T08:39:03","modified_gmt":"2023-07-13T06:39:03","slug":"regulatory-timetable-for-europes-biocontrol-application-on-track","status":"publish","type":"post","link":"https:\/\/amoeba-nature.com\/en\/regulatory-timetable-for-europes-biocontrol-application-on-track\/","title":{"rendered":"Regulatory timetable for Europe&#8217;s biocontrol application on track"},"content":{"rendered":"<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<h1 class=\"wp-block-heading has-text-align-center\">AMOEBA: Regulatory timetable for Europe&#8217;s biocontrol application on track<\/h1>\n<\/div><\/div><\/div>\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<p><strong>Chassieu (France), July 13<sup>th<\/sup>, 2023 &#8211; 08h30 &#8211;<\/strong>&nbsp;<strong>AMO\u00c9BA (FR0011051598 \u2013 ALMIB)<\/strong>&nbsp;an industrial biotech in pre-commercialization* specialized in the treatment of microbiological risk, developing a biocontrol agent for the treatment of plants in agriculture and a biological biocide for the treatment of industrial water, confirms that the regulatory timetable for the biocontrol active substance application is in line with the Company&#8217;s forecasts.<\/p>\n<\/div><\/div><\/div>\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<p>The EFSA, the European Food Safety Agency, mentions on&nbsp;<a href=\"https:\/\/open.efsa.europa.eu\/questions\/EFSA-Q-2020-00726\">its website<\/a>&nbsp;a Risk Assessment Deadline on July 19, 2023. As this date was assigned by default when the&nbsp;<a>peer-review&nbsp;<\/a>of dossier was initiated in December 2022, it does not take into account any delay by the authorities.<\/p>\n<\/div><\/div><\/div>\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<p>The Company had anticipated this possible delay in its forecasts: the regulatory timetable for its biocontrol applications in Europe, as published in the&nbsp;<a href=\"https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/04\/AMOEBA-URD-2022-V230418-vdef.pdf\">Universal Registration Document 2022<\/a>&nbsp;filed with the AMF on April 18, 2023 under the number D23-0296 and available on the Company&#8217;s website, is still valid and is recalled below:<\/p>\n<\/div><\/div><\/div>\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<ul class=\"wp-block-list\"><div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<li><strong>Risk assessment phase<\/strong>&nbsp;ending with EFSA&#8217;s peer-review report containing its conclusions: expected to be finalized in&nbsp;<em>the second half of 2023.<\/em><\/li>\n<\/div><\/div><\/div>\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<li><strong>Risk management phase&nbsp;<\/strong>ending with the publication of the implementing regulation containing the European Commission&#8217;s decision in the Official Journal of the EU: expected to be finalized&nbsp;<em>in the first half of 2024.<\/em><\/li>\n<\/div><\/div><\/div><\/ul>\n<\/div><\/div><\/div>\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<p>As applications for approval of formulated products can be submitted before&nbsp;<a>definitive approval of the active substance<\/a>, the forecast timetable for formulated products is also in line with the Company&#8217;s forecasts.<\/p>\n<\/div><\/div><\/div>\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"236\" src=\"https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52-1024x236.png\" alt=\"\" class=\"wp-image-5324\" srcset=\"https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52-1024x236.png 1024w, https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52-300x69.png 300w, https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52-768x177.png 768w, https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52-1536x353.png 1536w, https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52-400x92.png 400w, https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/Capture-decran-2023-07-13-a-08.19.52.png 1582w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n<div class=\"container\"><div class=\"row\"><div class=\"medium-large-full\">\n<p><a href=\"https:\/\/amoeba-nature.com\/wp-content\/uploads\/2023\/07\/CP-Regulatory-timetable-20230713-VDEF.pdf\">Read the press release in PDF <\/a><\/p>\n<\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>AMOEBA: Regulatory timetable for Europe&#8217;s biocontrol application on track Chassieu (France), July 13th, 2023 &#8211; 08h30 &#8211;&nbsp;AMO\u00c9BA (FR0011051598 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":5317,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[],"class_list":["post-5323","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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