{"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\/pt\/biopesticides\/biotalys-reports-progress-in-the-regulatory-review-of-evoca-in-both-u-s-and-eu\/","title":{"rendered":"Biotalys relata progresso na revis\u00e3o regulat\u00f3ria do EVOCA nos EUA e na UE"},"content":{"rendered":"<p><a href=\"https:\/\/www.biotalys.com\/\" target=\"_blank\" rel=\"noopener\">Biotalys<\/a>, uma empresa de tecnologia agr\u00edcola (AgTech) que desenvolve biocontroles baseados em prote\u00ednas para prote\u00e7\u00e3o sustent\u00e1vel de cultivos, tem o prazer de anunciar o progresso nos procedimentos de aprova\u00e7\u00e3o regulat\u00f3ria nos Estados Unidos e na Europa de seu primeiro produto de biocontrole baseado em prote\u00ednas, o EVOCA*.<\/p>\n<p>Nos EUA, a Biotalys recebeu uma comunica\u00e7\u00e3o da Ag\u00eancia de Prote\u00e7\u00e3o Ambiental (EPA) informando que a empresa respondeu a todos os pedidos de informa\u00e7\u00f5es adicionais da ag\u00eancia. A EPA projeta atualmente que concluir\u00e1 a revis\u00e3o cient\u00edfica do dossi\u00ea EVOCA ainda neste ver\u00e3o e tomar\u00e1 uma decis\u00e3o regulat\u00f3ria at\u00e9 30 de setembro de 2025.<\/p>\n<p>Na Europa, a Biotalys tem o prazer de confirmar que tanto o Conselho Holand\u00eas para Autoriza\u00e7\u00e3o de Produtos Fitossanit\u00e1rios (CTGB) quanto o Instituto Holand\u00eas de Sa\u00fade e Meio Ambiente (RIVM) forneceram avalia\u00e7\u00f5es positivas do dossi\u00ea regulat\u00f3rio da EVOCA, abrindo caminho para a fase de revis\u00e3o por pares em n\u00edvel europeu.<\/p>\n<p>Em sua revis\u00e3o, ambas as autoridades holandesas classificaram o ingrediente ativo do EVOCA como de baixo risco, com base nos dados atuais. Essa classifica\u00e7\u00e3o \u00e9 importante, pois reconhece o perfil de seguran\u00e7a do ingrediente ativo e est\u00e1 alinhada ao compromisso da Biotalys em fornecer solu\u00e7\u00f5es sustent\u00e1veis e eficazes para a prote\u00e7\u00e3o de cultivos. N\u00e3o foram identificadas \u00e1reas cr\u00edticas de preocupa\u00e7\u00e3o e, portanto, os Pa\u00edses Baixos, como Estado-Membro relator, prop\u00f5em que o ingrediente ativo do EVOCA possa ser aprovado na Europa, sujeito ao fornecimento de determinados dados adicionais durante a fase de revis\u00e3o por pares. A avalia\u00e7\u00e3o atual da Biotalys \u00e9 de que uma decis\u00e3o regulat\u00f3ria na Uni\u00e3o Europeia pode ser esperada no segundo semestre de 2026.<\/p>\n<p>Kevin Helash, CEO da Biotalys, afirmou: \u201cEstamos satisfeitos com o progresso regulat\u00f3rio nos EUA e na UE e aguardamos um resultado favor\u00e1vel. Uma decis\u00e3o de aprova\u00e7\u00e3o seria um marco importante para nossa empresa e uma valida\u00e7\u00e3o para nossa plataforma tecnol\u00f3gica exclusiva AGROBODY\u2122. Esta plataforma tem o potencial de desenvolver muitas outras solu\u00e7\u00f5es de biocontrole baseadas em prote\u00ednas para que os produtores possam combater pragas e doen\u00e7as importantes na agricultura. Sou muito grato pela revis\u00e3o e orienta\u00e7\u00e3o completas das ag\u00eancias reguladoras e pelo trabalho \u00e1rduo de nossa equipe para gerar e fornecer os dados cient\u00edficos necess\u00e1rios sobre nosso produto inovador.\u201d<\/p>\n<p>O primeiro biocontrole desenvolvido na plataforma tecnol\u00f3gica AGROBODY\u2122 da Biotalys, o EVOCA ajuda a controlar com seguran\u00e7a doen\u00e7as f\u00fangicas como Botrytis (mofo cinzento) e o\u00eddio para produtores de frutas e vegetais que buscam adicionar solu\u00e7\u00f5es eficazes e biodegrad\u00e1veis \u00e0s suas iniciativas de manejo integrado de pragas (MIP) para reduzir aplica\u00e7\u00f5es de produtos qu\u00edmicos.<\/p>\n<p><em>* EVOCA\u2122: Registro pendente. Este produto n\u00e3o est\u00e1 registrado para venda ou uso na Uni\u00e3o Europeia, nos Estados Unidos ou em qualquer outro lugar e n\u00e3o est\u00e1 sendo oferecido para venda.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>A EPA dos EUA espera uma decis\u00e3o regulat\u00f3ria at\u00e9 setembro, enquanto as autoridades holandesas finalizam a primeira fase do dossi\u00ea regulat\u00f3rio para o EVOCA na 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 v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Biotalys Reports Progress in the 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