{"id":78411,"date":"2025-01-15T14:59:13","date_gmt":"2025-01-15T19:59:13","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=78411"},"modified":"2025-01-19T16:37:15","modified_gmt":"2025-01-19T21:37:15","slug":"biotalys-provides-regulatory-review-update-on-evoca","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/es\/agrochemicals\/fungicides\/biotalys-provides-regulatory-review-update-on-evoca\/","title":{"rendered":"Biotalys proporciona informaci\u00f3n actualizada sobre la revisi\u00f3n regulatoria de EVOCA"},"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 soluciones de biocontrol basadas en prote\u00ednas para la protecci\u00f3n sustentable de cultivos, brinda hoy una actualizaci\u00f3n sobre el proceso de revisi\u00f3n regulatoria de su primer biofungicida, EVOCA, en Europa y Estados Unidos.<\/p>\n<h2>Uni\u00f3n Europea<\/h2>\n<p>Biotalys se complace en anunciar que la autoridad reguladora holandesa, CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden), ha proporcionado a la empresa su informe preliminar de evaluaci\u00f3n, en el que se recomienda la aprobaci\u00f3n del ingrediente activo de EVOCA en toda la Uni\u00f3n Europea. El CTGB enviar\u00e1 ahora su informe preliminar al Instituto Holand\u00e9s de Salud y Medio Ambiente (RIVM) para que aporte posibles comentarios sobre los requisitos de clasificaci\u00f3n, etiquetado y envasado, lo que dar\u00e1 lugar al cierre de la primera fase de la revisi\u00f3n regulatoria de EVOCA en Europa.<\/p>\n<p>Kevin Helash, director ejecutivo de Biotalys, afirm\u00f3: \u201cEste es un hito importante en el proceso de aprobaci\u00f3n regulatoria de nuestro primer biocontrol y lo consideramos un gran logro para nuestro equipo. El CTGB tiene una amplia experiencia en la evaluaci\u00f3n de biocontroles y estamos muy satisfechos con su recomendaci\u00f3n de aprobaci\u00f3n, ya que creemos que esto valida el potencial de nuestra innovadora plataforma tecnol\u00f3gica AGROBODY\u2122 para el desarrollo de nuevas soluciones de biocontrol para los productores. Si bien el proceso de revisi\u00f3n es largo y todav\u00eda queda mucho trabajo por hacer, obtener el apoyo del regulador en uno de los mayores pa\u00edses exportadores de frutas y verduras del mundo es una se\u00f1al de confianza en nuestra tecnolog\u00eda. Esperamos recibir nuestra primera aprobaci\u00f3n regulatoria completa en Europa\u201d.<\/p>\n<p>En la siguiente fase, la Autoridad Europea de Seguridad Alimentaria (AESA) y los estados miembros de la UE realizan revisiones exhaustivas del expediente y proporcionan comentarios al CTGB, al tiempo que permiten a Biotalys entregar determinados datos solicitados por el CTGB. Se espera que esta siguiente fase dure en total entre 12 y 18 meses e incluye tambi\u00e9n una consulta p\u00fablica, que finalizar\u00e1 con una votaci\u00f3n de los estados miembros europeos sobre la aprobaci\u00f3n del ingrediente activo a nivel de la UE.<\/p>\n<p>El proyecto de informe de evaluaci\u00f3n del CTGB surge a ra\u00edz de su reciente decisi\u00f3n, por la que la autoridad aprob\u00f3 ensayos de demostraci\u00f3n a gran escala de EVOCA en invernaderos, permitiendo al mismo tiempo que las frutas y verduras cosechadas se vendieran para el consumo humano.<\/p>\n<h2>Estados Unidos<\/h2>\n<p>La Agencia de Protecci\u00f3n Ambiental (EPA) contin\u00faa su revisi\u00f3n del expediente regulatorio de EVOCA en los Estados Unidos. Biotalys est\u00e1 trabajando en estrecha colaboraci\u00f3n con la EPA para avanzar con el expediente hasta obtener un resultado exitoso y planea brindar una actualizaci\u00f3n sobre la revisi\u00f3n de la EPA junto con el comunicado de prensa de los resultados de fin de a\u00f1o de la empresa y la transmisi\u00f3n web para inversores programada para el 19 de marzo de 2025.<\/p>\n<p>En paralelo con la EPA, el Departamento de Regulaci\u00f3n de Pesticidas de California (CDPR) ha estado revisando el expediente regulatorio de EVOCA presentado por Biotalys. Como se anunci\u00f3 anteriormente, la empresa entiende que el CDPR ha finalizado su propia revisi\u00f3n en profundidad, abriendo el camino hacia una r\u00e1pida aprobaci\u00f3n a nivel estatal en espera de la aprobaci\u00f3n del producto por parte de la EPA a nivel federal.<\/p>","protected":false},"excerpt":{"rendered":"<p>Biotalys, una empresa de tecnolog\u00eda agr\u00edcola (AgTech) que desarrolla soluciones de biocontrol basadas en prote\u00ednas para la protecci\u00f3n sustentable de cultivos, brinda hoy una actualizaci\u00f3n sobre\u2026<\/p>","protected":false},"author":1477,"featured_media":41620,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4,1604,22,18,489],"tags":[],"class_list":["post-78411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-agrochemicals","category-agtech","category-biopesticides","category-fungicides","category-industry-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Biotalys Provides Regulatory Review Update on EVOCA - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"Biotalys, an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for sustainable crop protection, today provides an\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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