{"id":79476,"date":"2025-06-11T14:00:25","date_gmt":"2025-06-11T18:00:25","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=79476"},"modified":"2025-06-11T14:00:25","modified_gmt":"2025-06-11T18:00:25","slug":"biotalys-reports-progress-in-the-regulatory-review-of-evoca-in-both-u-s-and-eu","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/es\/biopesticides\/biotalys-reports-progress-in-the-regulatory-review-of-evoca-in-both-u-s-and-eu\/","title":{"rendered":"Biotalys informa sobre avances en la revisi\u00f3n regulatoria de EVOCA tanto en EE. UU. como en la UE"},"content":{"rendered":"<p><a href=\"https:\/\/www.biotalys.com\/\" target=\"_blank\" rel=\"noopener\">Biotalys<\/a>, una empresa de tecnolog\u00eda agr\u00edcola (AgTech) que desarrolla biocontroles basados en prote\u00ednas para la protecci\u00f3n sustentable de cultivos, se complace en anunciar el progreso en los procedimientos de aprobaci\u00f3n regulatoria tanto en Estados Unidos como en Europa de su primer producto de biocontrol basado en prote\u00ednas, EVOCA*.<\/p>\n<p>En EE. UU., Biotalys recibi\u00f3 una comunicaci\u00f3n de la Agencia de Protecci\u00f3n Ambiental (EPA) indicando que la empresa ha respondido a todas las solicitudes de informaci\u00f3n adicional de la agencia. La EPA prev\u00e9 completar la revisi\u00f3n cient\u00edfica del expediente EVOCA a finales de este verano y tomar una decisi\u00f3n regulatoria antes del 30 de septiembre de 2025.<\/p>\n<p>En Europa, Biotalys se complace en confirmar que tanto la Junta Holandesa de Autorizaci\u00f3n de Productos Fitosanitarios (CTGB) como el Instituto Holand\u00e9s de Salud y Medio Ambiente (RIVM) han proporcionado evaluaciones positivas del expediente reglamentario de EVOCA, allanando el camino para la fase de revisi\u00f3n por pares a nivel europeo.<\/p>\n<p>En su revisi\u00f3n, ambas autoridades neerlandesas clasificaron el ingrediente activo de EVOCA como de bajo riesgo seg\u00fan los datos actuales. Esta clasificaci\u00f3n es importante, ya que reconoce el perfil de seguridad del ingrediente activo y se alinea con el compromiso de Biotalys de ofrecer soluciones sostenibles y eficaces para la protecci\u00f3n de cultivos. No se identificaron \u00e1reas cr\u00edticas de preocupaci\u00f3n, por lo que los Pa\u00edses Bajos, como Estado miembro ponente, proponen que el ingrediente activo de EVOCA pueda aprobarse en Europa, sujeto a la presentaci\u00f3n de ciertos datos adicionales durante la fase de revisi\u00f3n por pares. La evaluaci\u00f3n actual de Biotalys es que se espera una decisi\u00f3n regulatoria en la Uni\u00f3n Europea en el segundo semestre de 2026.<\/p>\n<p>Kevin Helash, director ejecutivo de Biotalys, afirm\u00f3: \u00abEstamos satisfechos con el progreso regulatorio tanto en EE. UU. como en la UE, y esperamos un resultado favorable. Una decisi\u00f3n de aprobaci\u00f3n ser\u00eda un hito importante para nuestra empresa y una validaci\u00f3n para nuestra exclusiva plataforma tecnol\u00f3gica AGROBODY\u2122. Esta plataforma tiene el potencial de desarrollar muchas m\u00e1s soluciones de biocontrol basadas en prote\u00ednas para que los agricultores combatan plagas y enfermedades clave en la agricultura. Estoy muy agradecido por la exhaustiva revisi\u00f3n y orientaci\u00f3n de las agencias reguladoras, y por el arduo trabajo de nuestro equipo para generar y proporcionar los datos cient\u00edficos necesarios sobre nuestro innovador producto\u00bb.<\/p>\n<p>EVOCA, el primer biocontrol desarrollado en la plataforma tecnol\u00f3gica AGROBODY\u2122 de Biotalys, ayuda a controlar de forma segura las enfermedades f\u00fangicas Botrytis (moho gris) y el mildi\u00fa polvoroso para los productores de frutas y verduras que buscan agregar soluciones efectivas y biodegradables a sus iniciativas de manejo integrado de plagas (MIP) para reducir las aplicaciones de productos qu\u00edmicos.<\/p>\n<p><em>* EVOCA\u2122: Pendiente de registro. Este producto no est\u00e1 registrado actualmente para su venta ni uso en la Uni\u00f3n Europea, Estados Unidos ni en ning\u00fan otro lugar, y no se ofrece para su venta.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>La EPA de EE. UU. espera una decisi\u00f3n regulatoria para septiembre, mientras que las autoridades holandesas finalizan la primera fase del expediente regulatorio para EVOCA en la UE.<\/p>","protected":false},"author":110,"featured_media":71850,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[22,489],"tags":[],"class_list":["post-79476","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopesticides","category-industry-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Biotalys Reports Progress in the Regulatory Review of EVOCA in both U.S. and EU - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"U.S. EPA expects a regulatory decision by September, while Dutch authorities finalize first phase of regulatory dossier for EVOCA in EU.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.agribusinessglobal.com\/es\/biopesticides\/biotalys-reports-progress-in-the-regulatory-review-of-evoca-in-both-u-s-and-eu\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biotalys Reports Progress in the Regulatory Review of EVOCA in both U.S. and EU - 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