{"id":1357,"date":"2025-11-18T17:55:03","date_gmt":"2025-11-18T16:55:03","guid":{"rendered":"https:\/\/devreg.eu\/?page_id=1357"},"modified":"2025-12-17T10:43:30","modified_gmt":"2025-12-17T09:43:30","slug":"elaboracion-de-expedientes-de-registro","status":"publish","type":"page","link":"https:\/\/devreg.eu\/en\/servicios-de-consulta-y-asuntos-reglamentarios\/elaboracion-de-expedientes-de-registro\/","title":{"rendered":"Registration dossier preparation"},"content":{"rendered":"\t\t
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DEVREG offers its consultancy services on pegistration of PPPs (pesticides, herbicides, fungicides, biopesticides) in the EU, based on a highly regulated, multi-step process, under:<\/p>\n

    \n
  • Regulation (EC) No 1107\/2009 \u2013 authorization of plant protection products<\/li>\n
  • Regulation (EC) No 396\/2005 \u2013 maximum residue levels (MRLs)<\/li>\n
  • Regulation (EU) 2024\/\u2026 updates & ongoing amendments<\/li>\n<\/ul>\n
      \n
    • Assessment of active substance and product eligibility<\/li>\n
    • Identification of data gaps<\/li>\n
    • Planning the registration path (EU, zonal, mutual recognition)<\/li>\n
    • Cost and timeline forecasting<\/li>\n<\/ul>\n

      Dossier preparation for registration of plant production products:<\/span><\/p>\n

      DEVREG has the capability and expertise to prepare and submit dossiers for registration of formulated products, including:<\/p>\n

        \n
      • Comprehensive Draft Registration Report (dRR), including all relevant sections<\/li>\n
      • Physical\u2013chemical data & compatibility studies<\/li>\n
      • Toxicological and environmental classification according CLP Regulation<\/li>\n
      • Operator, worker, bystander exposure models<\/li>\n
      • GAP table & efficacy summary<\/li>\n
      • Efate modelling<\/li>\n
      • Risk assessments (human health, environmental, ecotoxicology, dietary, groundwater)<\/li>\n<\/ul>\n

        Zonal & Interzonal, and national applications.<\/span><\/p>

        Regulation 1107\/2009 divides Eu into three zones for PPP evaluation and authorisation:<\/p>

        • Northern zone<\/li>
        • Central zone<\/li>
        • Southern zone<\/li><\/ul>

          Applications are evaluated on a zonal basis, but for some uses the EU is considered a single zone and a single Member State can evaluate a PPP on behalf of the entire EU; these uses are greenhouse uses, post-harvest treatments, treatment of empty storage rooms or containers and seed treatments<\/p>

          And designated zRMS assess applications on behalf of other countries in their zone (generally, openfield uses) and sometimes on behalf of all zones (protected and indoor uses).<\/p>

          DEVREG services include:<\/p>

          • Preparation of zonal dossiers<\/li>
          • Liaison with the zonal\/interzonal rapporteur Member State (zRMS)<\/li>
          • Mutual recognition applications in other EU countries<\/li>
          • Response to Member State comments and data requests<\/li>
          • Communications with Authorities, including Rapporteur Member States (zRMS\/izRMS),  National competent authorities (ANSES, MAPA, DGAV, BVL, Ctgb, etc.)<\/li>
          • Support during peer review and expert meetings<\/li><\/ul>

            Coverning a signification number of EU Member States, directly by our technical and regulatory staff or through national consultants with high expertise on these regulatory areas, manage and follow submissions, etc.<\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

            DEVREG offers its consultancy services on pegistration of PPPs (pesticides, herbicides, fungicides, biopesticides) in the EU, based on a highly regulated, multi-step process, under: Regulation (EC) No 1107\/2009 \u2013 authorization of plant protection products Regulation (EC) No 396\/2005 \u2013 maximum residue levels (MRLs) Regulation (EU) 2024\/\u2026 updates & ongoing amendments Assessment of active substance and […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1177,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","footnotes":""},"class_list":["post-1357","page","type-page","status-publish","hentry","entry"],"_links":{"self":[{"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/pages\/1357","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/comments?post=1357"}],"version-history":[{"count":11,"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/pages\/1357\/revisions"}],"predecessor-version":[{"id":1608,"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/pages\/1357\/revisions\/1608"}],"up":[{"embeddable":true,"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/pages\/1177"}],"wp:attachment":[{"href":"https:\/\/devreg.eu\/en\/wp-json\/wp\/v2\/media?parent=1357"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}