{"id":6520,"date":"2023-02-28T08:52:50","date_gmt":"2023-02-28T08:52:50","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=6520"},"modified":"2023-03-07T08:27:02","modified_gmt":"2023-03-07T08:27:02","slug":"france-anses-new-decree-on-fees","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-anses-new-decree-on-fees\/","title":{"rendered":"FRANCE\u2013ANSES : new decree on fees"},"content":{"rendered":"<p style=\"text-align: justify\"><a href=\"https:\/\/www.legifrance.gouv.fr\/jorf\/id\/JORFTEXT000046793208\" target=\"_blank\" rel=\"noopener\">The decree of December 15, 2022, setting the fees to be paid to Anses, relating to marketing authorization for phytopharmaceutical products, adjuvants, fertilisers and growing media,<\/a> will enter in force on <b>April 1, 2023<\/b>, and will repeal the decree of April 12, 2017.<\/p>\n<p style=\"text-align: justify\">This new decree clarifies some already existing provisions, and completes them with categories of demand which were not previously included.<\/p>\n<p style=\"text-align: justify\">Data tabulation, with fee amounts depending on the status of France (rapporteur or co-rapporteur Member State for active substances, zonal rapporteur or concerned Member State for products) simplifies the reading.<\/p>\n<p style=\"text-align: justify\">Among the novelties :<\/p>\n<ul>\n<li style=\"text-align: justify\">Clarifications regarding <b>biocontrol products<\/b> (as defined in article <a href=\"https:\/\/www.legifrance.gouv.fr\/codes\/article_lc\/LEGIARTI000042911985\/2023-02-27\/\" target=\"_blank\" rel=\"noopener\">L. 253-6 2\u00b0 of the French rural code<\/a>) with a fee limited at <b>2 000 \u20ac<\/b> whatever the demand, for products composed of either\u00a0 <b>micro-organisms<\/b>, either <b>semiochemicals<\/b>, or <b>natural substances of plant origin<\/b> obtained by <b>mechanical process or by water or hydro-alcoholic extraction<\/b>, and not containing active substance candidate for substitution.<\/li>\n<\/ul>\n<p style=\"text-align: justify\">The fees are capped at <b>25 000 \u20ac<\/b> for any demand for <b>biocontrol products<\/b> composed of <b>natural substances<\/b>, either of <b>plant origin<\/b> and obtained by a <b>process other<\/b> than mechanical or water or hydro-alcoholic extraction, or of <b>animal or mineral origin<\/b>, and not containing active substance candidate for substitution.<\/p>\n<ul>\n<li style=\"text-align: justify\">Addition of a specific category for demands concerning <b>resale products<\/b> (as defined in article <a href=\"https:\/\/www.legifrance.gouv.fr\/codes\/article_lc\/LEGIARTI000030823408\/2023-02-27\/\" target=\"_blank\" rel=\"noopener\">D.253-9 of the French rural code<\/a>).<\/li>\n<li style=\"text-align: justify\">For <b>label extensions<\/b>, clarification on the demands containing <b>both major and minor uses<\/b>.<\/li>\n<li style=\"text-align: justify\">New category for major or <b>significant change in the nature or content of co-formulants<\/b> for an already authorised product, including the <b>submission of new studies or risk assessments<\/b>.<\/li>\n<li style=\"text-align: justify\">Possibility of <b>re-submission<\/b>, with a <b>fee divided by 2<\/b>, only<b> within 6 months<\/b> <b>following the refusal of approval of a<\/b> demand.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download (in French) :<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/www.legifrance.gouv.fr\/jorf\/id\/JORFTEXT000046793208\" target=\"_blank\" rel=\"noopener\">Decree of 15 December 2022<\/a><\/p>\n<p style=\"text-align: justify\">\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\/france-anses-new-fees\/\" target=\"_blank\" rel=\"noopener\">FRANCE &#8211; ANSES: New fees &#8211; Lynxee consulting<\/a><\/p>\n<p style=\"text-align: justify\">\n<p style=\"text-align: justify\"><b>Lynxee consulting<\/b>\u2019s team is at your disposal to answer your questions.<\/p>\n<p style=\"text-align: justify\"><b>Contact us!<\/b> <a href=\"http:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener\">http:\/\/lynxee.consulting\/en\/contact\/<\/a><\/p>\n<p>&nbsp;<\/p>\n<h6>Photo credit : nattanan23\/pixabay<\/h6>\n","protected":false},"excerpt":{"rendered":"<p>The decree of December 15, 2022, setting the fees to be paid to Anses, relating to marketing authorization for phytopharmaceutical products, adjuvants, fertilisers and growing media,<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":14,"featured_media":6518,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15,36],"tags":[64,430],"class_list":["post-6520","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classe-en","category-regulation","tag-anses-en","tag-fees"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FRANCE\u2013ANSES : new decree on fees - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"The decree of December 15, 2022, setting the fees to be paid to Anses, relating to marketing authorization for phytopharmaceutical products, adjuvants,\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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