{"id":133922,"date":"2025-08-01T12:58:18","date_gmt":"2025-08-01T16:58:18","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=133922"},"modified":"2026-02-03T13:02:05","modified_gmt":"2026-02-03T18:02:05","slug":"regulatory-shifts-in-u-s-and-europe-what-biological-innovators-must-know-2","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/plant-health\/biostimulants\/regulatory-shifts-in-u-s-and-europe-what-biological-innovators-must-know-2\/","title":{"rendered":"Mudan\u00e7as regulat\u00f3rias nos EUA e na Europa: o que os inovadores biol\u00f3gicos precisam saber"},"content":{"rendered":"<p>Para as empresas de tecnologia agr\u00edcola, 2025 n\u00e3o significa apenas desenvolver solu\u00e7\u00f5es inovadoras, mas tamb\u00e9m avan\u00e7ar. Mudan\u00e7as regulat\u00f3rias nos EUA e na UE est\u00e3o alterando as regras para bioestimulantes, biopesticidas e produtos microbianos. Embora complexas, essas mudan\u00e7as criam oportunidades para empresas que se preparam com anteced\u00eancia e pensam estrategicamente.<\/p>\n<p>Os EUA est\u00e3o fazendo o t\u00e3o esperado progresso em dire\u00e7\u00e3o a diretrizes mais claras para produtos biol\u00f3gicos, enquanto a UE busca melhorar a consist\u00eancia por meio de atualiza\u00e7\u00f5es regulat\u00f3rias, mesmo que ainda haja desafios.<\/p>\n<h2>EUA: Rumo a um caminho mais claro<\/h2>\n<p>O ano de 2025 marca um ponto de virada para a regulamenta\u00e7\u00e3o de insumos biol\u00f3gicos nos EUA. Enquanto as ag\u00eancias federais buscam maior consist\u00eancia, as pol\u00edticas estaduais emergentes est\u00e3o criando novas exig\u00eancias de conformidade que exigem navega\u00e7\u00e3o cuidadosa e planejamento estrat\u00e9gico.<\/p>\n<p><strong>Lei de Bioestimulantes Vegetais Reintroduzida<\/strong><br \/>\nUm projeto de lei bipartid\u00e1rio, reintroduzido em 2025, prop\u00f5e uma defini\u00e7\u00e3o federal para bioestimulantes vegetais e instrui a Ag\u00eancia de Prote\u00e7\u00e3o Ambiental dos EUA (EPA) e o Departamento de Agricultura dos Estados Unidos (USDA) a estabelecerem uma estrutura regulat\u00f3ria consistente. Atualmente, insumos bioqu\u00edmicos, microbianos e \u00e0 base de algas marinhas encontram-se em uma zona cinzenta regulat\u00f3ria \u2014 \u00e0s vezes classificados como fertilizantes, corretivos de solo ou corretivos foliares em n\u00edvel estadual, e outras vezes como pesticidas ou reguladores de crescimento vegetal por ag\u00eancias federais e estaduais. Essa ambiguidade levou a padr\u00f5es de revis\u00e3o inconsistentes. O projeto de lei proposto visa eliminar confus\u00f5es e agilizar o processo de aprova\u00e7\u00e3o de produtos bioestimulantes.<\/p>\n<p><strong>Atualiza\u00e7\u00e3o da orienta\u00e7\u00e3o da EPA sobre bioestimulantes<\/strong><br \/>\nA EPA divulgou recentemente um rascunho de orienta\u00e7\u00e3o atualizado que esclarece quais ingredientes e declara\u00e7\u00f5es de r\u00f3tulos se enquadram na regulamenta\u00e7\u00e3o FIFRA. Essa orienta\u00e7\u00e3o est\u00e1 ajudando as empresas a determinar antecipadamente se seus produtos exigem registro como reguladores de crescimento vegetal ou se qualificam sob as leis de fertilizantes. Tornou-se um recurso essencial durante o desenvolvimento inicial de produtos. No entanto, mesmo com essa clareza federal atualizada, muitos estados est\u00e3o intensificando o escrut\u00ednio de produtos bioestimulantes. Alguns agora exigem que os registrantes solicitem \u00e0 EPA determina\u00e7\u00f5es n\u00e3o FIFRA antes do registro estadual.<\/p>\n<p><strong>PRIA 5 e requisitos de n\u00edvel estadual<\/strong><br \/>\nAs atualiza\u00e7\u00f5es do PRIA 5 introduziram taxas mais altas, novas categorias de revis\u00e3o e ajustaram os prazos de registro federal. Ao mesmo tempo, estados como Calif\u00f3rnia e Nova York est\u00e3o implementando requisitos que excedem os padr\u00f5es da EPA, incluindo divulga\u00e7\u00e3o completa e dados de toxicidade para ingredientes inertes e adjuvantes. Essas camadas adicionais de regulamenta\u00e7\u00e3o est\u00e3o tornando a implementa\u00e7\u00e3o coordenada de produtos em n\u00edvel nacional mais desafiadora e custosa.<\/p>\n<h2>UE: Entrada mais f\u00e1cil e expectativas mais elevadas<\/h2>\n<p>A Uni\u00e3o Europeia delineou planos para apoiar a inova\u00e7\u00e3o biol\u00f3gica, mas seu arcabou\u00e7o regulat\u00f3rio atual ainda reflete o dos produtos sint\u00e9ticos, gerando atrasos nas aprova\u00e7\u00f5es biol\u00f3gicas. Embora os formuladores de pol\u00edticas estejam come\u00e7ando a explorar caminhos regulat\u00f3rios mais personalizados, o progresso levar\u00e1 tempo. Por enquanto, a UE continua sendo um mercado complexo e com altos n\u00edveis de barreiras, onde o sucesso depende de dados robustos, efic\u00e1cia comprovada e capacidade de superar obst\u00e1culos regulat\u00f3rios.<\/p>\n<p><strong>Regulamento (UE) 2022\/1438: Processo de aprova\u00e7\u00e3o microbiana atualizado<\/strong><br \/>\nEste regulamento de 2022, agora em pleno vigor, altera o Anexo II do Regulamento (CE) n.\u00ba 1107\/2009 para refinar os crit\u00e9rios de aprova\u00e7\u00e3o de subst\u00e2ncias ativas microbianas. Embora n\u00e3o seja novo, continua altamente relevante em 2025, \u00e0 medida que mais empresas o utilizam para simplificar os requisitos de dossi\u00eas e acelerar a entrada no mercado. Embora possa ser muito cedo para ver resultados mensur\u00e1veis das aprova\u00e7\u00f5es iniciais com base nos crit\u00e9rios atualizados, espera-se que o regulamento melhore a consist\u00eancia entre os Estados-Membros e aumente a previsibilidade para os requerentes, refor\u00e7ando a sua import\u00e2ncia cont\u00ednua.<\/p>\n<p><strong>Depois do SUR: Planos Nacionais Avan\u00e7am<\/strong><br \/>\nAp\u00f3s a rejei\u00e7\u00e3o do Regulamento de Utiliza\u00e7\u00e3o Sustent\u00e1vel (RUS) pelo Parlamento Europeu em 2023, a pol\u00edtica da UE mudou o foco das metas de redu\u00e7\u00e3o para prioridades como a seguran\u00e7a alimentar e a resili\u00eancia agr\u00edcola. Em 2025, v\u00e1rios Estados-Membros est\u00e3o a desenvolver estrat\u00e9gias nacionais que promovem a gest\u00e3o integrada de pragas (GIP), bem como alternativas org\u00e2nicas e mec\u00e2nicas. Para as empresas que procuram aprova\u00e7\u00f5es de produtos, a colabora\u00e7\u00e3o com especialistas regionais em desenvolvimento de campo e regulamenta\u00e7\u00e3o \u00e9 fundamental para superar as complexidades do mercado e captar valor nesta regi\u00e3o de elevado potencial.<\/p>","protected":false},"excerpt":{"rendered":"<p>Para as empresas de tecnologia agr\u00edcola, 2025 n\u00e3o se trata apenas de desenvolver solu\u00e7\u00f5es inovadoras, mas tamb\u00e9m de sair na frente. Mudan\u00e7as regulat\u00f3rias em\u2026<\/p>","protected":false},"author":110,"featured_media":74333,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[929,926],"tags":[1984],"class_list":["post-133922","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biostimulants","category-plant-health","tag-abg-direct-august-2025"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory Shifts in U.S. and Europe: What Biological Innovators Must Know - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"For ag-tech companies, 2025 is not just about developing innovative solutions, it is also about getting ahead. 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