{"id":134389,"date":"2024-11-01T11:08:45","date_gmt":"2024-11-01T15:08:45","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=134389"},"modified":"2026-03-26T11:09:39","modified_gmt":"2026-03-26T15:09:39","slug":"eu-discussions-for-moving-biological-products-to-market-faster-in-2025-will-it-happen","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/es\/markets\/europe\/eu-discussions-for-moving-biological-products-to-market-faster-in-2025-will-it-happen\/","title":{"rendered":"Debates en la UE sobre c\u00f3mo acelerar la comercializaci\u00f3n de productos biol\u00f3gicos en 2025: \u00bfse concretar\u00e1n?"},"content":{"rendered":"<p>Seg\u00fan la Asociaci\u00f3n Internacional de Fabricantes de Biocontrol (IBMA), las tecnolog\u00edas de biocontrol tienen su origen en la naturaleza, directamente o de forma id\u00e9ntica a ella si se sintetizan.<\/p>\n<p>IBMA incluye cuatro categor\u00edas de productos de biocontrol:<\/p>\n<p><strong>1. Mediadores qu\u00edmicos<\/strong> que son sustancias emitidas por plantas, animales y otros organismos, utilizadas para la comunicaci\u00f3n intra-especie y\/o inter-especie. Tienen un modo de acci\u00f3n espec\u00edfico sobre el objetivo y no son t\u00f3xicas (feronomas, kairomonas, etc.).<\/p>\n<p><strong>2. Microorganismos<\/strong> que incluye bacterias, hongos, protozoos, virus, viroides, micoplasmas y puede incluir microorganismos completos, c\u00e9lulas vivas y muertas, cualquier metabolito microbiano asociado, materiales de fermentaci\u00f3n y fragmentos de c\u00e9lulas.<\/p>\n<p><strong>3. Sustancias naturales<\/strong> que consisten en uno o m\u00e1s componentes de la naturaleza, incluyendo plantas, algas\/microalgas, animales, minerales, bacterias, hongos, p\u00e9ptidos, protozoos, virus, viroides y micoplasmas. Pueden ser de origen natural o id\u00e9nticos a la naturaleza si son sintetizados.<\/p>\n<p><strong>4. Macroorganismos<\/strong> que son plagas naturales como especies de insectos, \u00e1caros y nematodos, que controlan las poblaciones de plagas mediante depredaci\u00f3n o parasitismo.<\/p>\n<p>En Francia, el biocontrol se define como el \u201cconjunto de m\u00e9todos preventivos y curativos de protecci\u00f3n de las plantas contra las plagas de los cultivos, basados en los procesos naturales que act\u00faan en los ecosistemas\u201d (V\u00e9g\u00e9phyl). Mientras que para el C\u00f3digo Rural y de Pesca Mar\u00edtima (L. 253-6), los productos de biocontrol son \u201cagentes y productos que utilizan mecanismos naturales en el marco de una gesti\u00f3n integrada de las plagas de los cultivos\u201d.<\/p>\n<p>Sin embargo, como se\u00f1ala IBMA en su comunicaci\u00f3n de 30 de marzo de 2022 (IBMA, 2022), no existe una legislaci\u00f3n europea espec\u00edfica para la aprobaci\u00f3n de sustancias de biocontrol y el registro de productos. Por ello, la Autorizaci\u00f3n de Comercializaci\u00f3n (AC) de estos productos sigue el proceso de aprobaci\u00f3n com\u00fan para todas las sustancias activas en Europa. El primer paso es la aprobaci\u00f3n de la sustancia activa a nivel europeo, y el segundo paso es la AC del producto a nivel nacional, una vez que la sustancia ha sido aprobada a nivel europeo.<\/p>\n<p>En su comunicaci\u00f3n, la IBMA subraya tambi\u00e9n la urgencia de dar una definici\u00f3n jur\u00eddica europea del biocontrol, as\u00ed como un marco legislativo europeo adaptado, como puede que ya exista al otro lado del Atl\u00e1ntico. Pero estas dificultades no impiden la expansi\u00f3n de estos m\u00e9todos alternativos de tratamiento de los cultivos gracias a los fruct\u00edferos debates entre los solicitantes y las autoridades tanto nacionales como europeas.<\/p>\n<h2>Cinco puntos importantes para los debates sobre biocontrol del pr\u00f3ximo a\u00f1o<\/h2>\n<p>En lo que se refiere al biocontrol, como puede ver se esperan una multitud de factores en el futuro cercano. Si resumimos lo que se espera, o se desea, para el a\u00f1o 2025, podemos destacar los cinco puntos:<\/p>\n<ul>\n<li>Nos estamos acercando a una definici\u00f3n de biocontrol con la inclusi\u00f3n del biocontrol en el di\u00e1logo estrat\u00e9gico sobre el futuro de la agricultura de la UE.<\/li>\n<li>La Comisi\u00f3n Europea y los Estados miembros ya est\u00e1n debatiendo propuestas de modificaci\u00f3n de los reglamentos (UE) n.\u00ba 546\/2011, n.\u00ba 283\/2013 y n.\u00ba 264\/2013 para a\u00f1adir especificidades de las sustancias de origen biol\u00f3gico y natural. Estos intercambios deber\u00edan proseguir el a\u00f1o pr\u00f3ximo.<\/li>\n<li>Se est\u00e1 discutiendo un nuevo formato de etiquetado para implementar en 2026 y el pr\u00f3ximo intercambio puede tener un impacto en los productos biol\u00f3gicos.<\/li>\n<li>Cada vez son m\u00e1s los pa\u00edses que fijan su plan de reducci\u00f3n del uso de plaguicidas con, entre otros objetivos, reforzar el desarrollo de alternativas biol\u00f3gicas.<\/li>\n<li>La Organizaci\u00f3n Europea y Mediterr\u00e1nea para la Protecci\u00f3n de las Plantas (EPPO) ha trabajado durante los dos \u00faltimos a\u00f1os en la validaci\u00f3n de una gu\u00eda sobre c\u00f3mo utilizar las tecnolog\u00edas digitales en la experimentaci\u00f3n de eficacia. El resultado de este trabajo deber\u00eda verse en los campos en 2025.<br \/>\nEncontrar alternativas es genial, llevarlas al mercado es mejor.<\/li>\n<\/ul>\n<p>Actualmente, el mercado de las soluciones fitosanitarias est\u00e1 experimentando un cambio. Cada vez m\u00e1s sustancias no se renuevan porque no superan los criterios de aceptaci\u00f3n. Esto genera incertidumbre entre los productores, que ven c\u00f3mo se les quitan sus herramientas habituales.<\/p>\n<p>Mientras tanto, se identifican y dise\u00f1an alternativas, primero como posibles reemplazos de las sustancias retiradas, pero m\u00e1s importante a\u00fan, en mayor medida, como herramientas para definir nuevos modelos de producci\u00f3n de cultivos.<\/p>\n<p>Surge una preocupaci\u00f3n cuando el presupuesto y los plazos para la implementaci\u00f3n de estas soluciones dependen de los productores.<\/p>\n<p>Una sustancia puede tardar menos de tres a\u00f1os entre las conclusiones de la evaluaci\u00f3n de la EFSA y la \u00faltima fecha de uso autorizado. Por el contrario, cuando se trata de productos de biocontrol regulados, se necesitan entre siete y diez a\u00f1os para obtener el registro, sin contar el tiempo necesario para que los usuarios finales acepten la innovaci\u00f3n.<\/p>\n<p>La mayor\u00eda de las innovaciones est\u00e1n respaldadas por peque\u00f1as empresas que luchan por financiar el expediente de registro, que cuesta al menos un mill\u00f3n de euros, sin facturar durante una d\u00e9cada.<\/p>\n<p>Para desarrollar un producto de biocontrol, el presupuesto para los estudios necesarios puede reducirse significativamente si los datos se pueden extrapolar a partir de los datos de la \u201csustancia\u201d. As\u00ed, la mayor parte se destinar\u00e1 a ensayos de eficacia, as\u00ed como a estudios ecotoxicol\u00f3gicos (efectos sobre abejas y artr\u00f3podos no objetivo). Los ensayos toxicol\u00f3gicos y de residuos suelen ser limitados o inexistentes cuando se trata de una sustancia de bajo riesgo con efectos muy limitados sobre los seres humanos. Por \u00faltimo, la caracterizaci\u00f3n fisicoqu\u00edmica del producto, as\u00ed como el coste de redacci\u00f3n y evaluaci\u00f3n de riesgos, representan un coste intermedio.<\/p>\n<p>Gran parte de la industria espera que se produzca un cambio en la inercia del registro europeo para evitar que Europa se quede atr\u00e1s en comparaci\u00f3n con otros continentes que actualmente est\u00e1n experimentando un auge en el sector de los productos biol\u00f3gicos.<\/p>","protected":false},"excerpt":{"rendered":"<p>Un vistazo al plan de la UE para acelerar la comercializaci\u00f3n de productos biol\u00f3gicos.<\/p>","protected":false},"author":2163,"featured_media":71491,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1786,29,5],"tags":[1988],"class_list":["post-134389","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biologicals","category-europe","category-markets","tag-abg-direct-november-2024"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EU Discussions for Moving Biological Products to Market Faster in 2025\u2014Will It Happen? - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"A look into the EU&#039;s plan to move biologicals to market faster.\" \/>\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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