{"id":5857,"date":"2022-09-30T07:22:26","date_gmt":"2022-09-30T07:22:26","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=5857"},"modified":"2023-01-26T14:59:03","modified_gmt":"2023-01-26T14:59:03","slug":"france-anses-update-of-the-explanatory-notes-cerfa-form-and-application-procedure","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-anses-update-of-the-explanatory-notes-cerfa-form-and-application-procedure\/","title":{"rendered":"FRANCE &#8211; ANSES : Update of the explanatory notes, cerfa form and application procedure"},"content":{"rendered":"<p style=\"text-align: justify\"><b>ANSES has updated<\/b><span style=\"font-weight: 400\"> on 28.09.2022 <\/span><b>the general note for the submission of applications for a marketing authorisation or a permit for plant protection products, adjuvants and mixed products<\/b><span style=\"font-weight: 400\">. It introduces the third version of the explanatory note No 52173 and its related administrative cerfa form No 15722 as well the second version of the explanatory note No 52175 to fill in the composition cerfa form No 15724.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The main changes of the third versions of the explanatory note No. 52173 and administrative cerfa form No 15722 are as follows:<\/span><\/p>\n<ul style=\"text-align: justify\">\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Integration of the <\/span><b>new provisions for the protection of bees and other pollinators<\/b><span style=\"font-weight: 400\"> in accordance with the Order of November 20, 2021. The request for a derogation under the decree of November 28, 2003 (EX, FL or EX\/FL mentions) disappears in favour of a derogation for use during flowering on crops attractive to pollinators (EP mention).<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Natural substances of plant origin not subject to chemical transformation<\/b><span style=\"font-weight: 400\"> are defined as natural substances obtained by mechanical means or by water or hydroalcoholic extraction. The category \u00ab substance identical to natural substance \u00bb is now added in the cerfa form.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Introduction of the function \u00ab <\/span><b>Plant defence stimulator <\/b><span style=\"font-weight: 400\">\u00bb.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Introduction of the applications as products intended for \u00ab <\/span><b>amateur organic production <\/b><span style=\"font-weight: 400\">\u00bb and \u00ab <\/span><b>for use in organic farming<\/b><span style=\"font-weight: 400\"> \u00bb for professionals.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Introduction of the <\/span><b>application for renewal of an authorisation granted for 5 years under Article 50.3<\/b><span style=\"font-weight: 400\"> of Regulation (EC) No 1107\/2009, to which Article 43 of that Regulation does not apply.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>New information requirements for product packaging <\/b><span style=\"font-weight: 400\">are detailed in particular the need to specify, for volumes greater than 50 L, whether the packaging can be equipped with a system allowing homogenisation (applicable for SC, EC and SE formulations). Also, in case the volume of the packaging (container) is different from the net volume or mass (content), it is requested to report the volume of the container in the &#8220;quantity claimed&#8221; section and to specify the net volume(s) or weight(s) of the product in the &#8220;comments&#8221; section.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Introduction of the possibility to indicate the <\/span><b>manufacturing sites t<\/b><span style=\"font-weight: 400\">o be added or deleted in the case of a request to modify the information declared in an on-going dossier aiming at modifying the manufacturing site of a product.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The constitution of the PPP and adjuvant dossiers (Annex I and II), the templates (Annex III) and the numbering of the documents to be used in the application (Annex IV) have been updated.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The <\/span><b>elements relating to PPE<\/b><span style=\"font-weight: 400\"> must be included in the dedicated chapter of part A of the dossier submitted by the applicant if France is zRMS, or in a national addendum if France is not zRMS.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The procedure to be followed in case of <\/span><b>modification of the contact person<\/b><span style=\"font-weight: 400\">&#8216;s email address is provided.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Regarding the application procedure, in the case of <\/span><b>simultaneous submissions of several dossiers<\/b><span style=\"font-weight: 400\">, only one payment of the fee is possible for all applications. <\/span><b>Electronic signature of the cerfa<\/b><span style=\"font-weight: 400\"> is allowed. Non-rewritable CD\/DVDs containing the dossier can only be sent by post to Anses if no other electronic solution is possible. It is no longer possible to submit dossiers in paper format.\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Noted that the Cerfa 15722*03 form can either be filled in directly or completed via the <\/span><a href=\"https:\/\/dphy.anses.fr\/#\/login\" target=\"_blank\" rel=\"noopener\"><b>DPhy<\/b><\/a><span style=\"font-weight: 400\"> teleservice platform.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Finally, with regard to the explanatory note on the composition cerfa form, it is now required to <\/span><b>submit the 100% detailed composition of each co-formulant presented in the form of a trade formulation or in the form of an undefined formulation<\/b><span style=\"font-weight: 400\"> so that the compliance of the composition of the plant protection product with Regulation (EU) 2021\/383 (list of non accepted co-formulants) can be verified. The compositions may be submitted directly by the supplier within 1 month after submission of the associated dossier.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">In addition, if the co-formulant presented as a commercial formulation or as an undefined formulation contains <\/span><b>hydrocarbons<\/b><span style=\"font-weight: 400\">, the <\/span><b>maximum content of benzene or DMSO extract<\/b><span style=\"font-weight: 400\"> (depending on the type of hydrocarbon) in these hydrocarbons must be specified.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download <\/b><i><span style=\"font-weight: 400\">(in French)<\/span><\/i><b>:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/www.anses.fr\/fr\/system\/files\/Note_formulaires_notices_dossier_PPP.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Note g\u00e9n\u00e9rale pour le d\u00e9p\u00f4t des dossiers (formulaires Cerfa et notices \u00e0 utiliser)<\/span><\/a><span style=\"font-weight: 400\"> (28\/09\/2022)<\/span><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=52173&amp;cerfaFormulaire=15722\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Notice explicative pour remplir le formulaire relatif \u00e0 une autorisation de mise sur le march\u00e9 Cerfa N\u00b052173#03 (pdf)<\/span><\/a><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Formulaire relatif \u00e0 une autorisation de mise sur le march\u00e9 <\/span><a href=\"https:\/\/www.anses.fr\/fr\/system\/files\/CERFA_15722x03_PPP.doc\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Cerfa N\u00b0 15722*03 (word)<\/span><\/a> <span style=\"font-weight: 400\">ou <\/span><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/cerfa_15722.do\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Cerfa N\u00b0 15722*03 (pdf)<\/span><\/a><span style=\"font-weight: 400\">\u00a0\u00a0<\/span><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=52175&amp;cerfaFormulaire=15724\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Notice explicative pour remplir le formulaire de composition int\u00e9grale N\u00b052175#02<\/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><span style=\"font-weight: 400\">Photo credit : geralt<\/span><span style=\"font-weight: 400\">\/pixabay<\/span><\/h6>\n","protected":false},"excerpt":{"rendered":"<p>ANSES has updated on 28.09.2022 the general note for the submission of applications for a marketing authorisation or a permit for plant protection products, adjuvants and<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":11,"featured_media":5850,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[125,64,396,395,397],"class_list":["post-5857","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-amm-en","tag-anses-en","tag-cerfa-form","tag-explanatory-notes","tag-marketing-authorisation"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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