{"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\/pt\/markets\/europe\/eu-discussions-for-moving-biological-products-to-market-faster-in-2025-will-it-happen\/","title":{"rendered":"Discuss\u00f5es da UE para levar produtos biol\u00f3gicos ao mercado mais rapidamente em 2025 \u2014 isso vai acontecer?"},"content":{"rendered":"<p>De acordo com a Associa\u00e7\u00e3o Internacional de Fabricantes de Produtos de Biocontrole (IBMA), as tecnologias de biocontrole t\u00eam origem na natureza \u2013 seja diretamente ou de forma id\u00eantica \u00e0 natureza, caso sejam sintetizadas.<\/p>\n<p>O IBMA inclui quatro categorias de produtos de biocontrole:<\/p>\n<p><strong>1. Mediadores qu\u00edmicos<\/strong> que s\u00e3o subst\u00e2ncias emitidas por plantas, animais e outros organismos, usadas para comunica\u00e7\u00e3o intra-esp\u00e9cies e\/ou inter-esp\u00e9cies. Elas t\u00eam um modo de a\u00e7\u00e3o espec\u00edfico para o alvo e n\u00e3o s\u00e3o t\u00f3xicas (feronomas, cairomonas, etc.).<\/p>\n<p><strong>2. Microrganismos<\/strong> que inclui bact\u00e9rias, fungos, protozo\u00e1rios, v\u00edrus, viroides, micoplasmas e pode incluir microrganismos inteiros, c\u00e9lulas vivas e mortas, quaisquer metab\u00f3litos microbianos associados, materiais de fermenta\u00e7\u00e3o e fragmentos de c\u00e9lulas.<\/p>\n<p><strong>3. Subst\u00e2ncias naturais<\/strong> que consistem em um ou mais componentes da natureza, incluindo plantas, algas\/microalgas, animais, minerais, bact\u00e9rias, fungos, pept\u00eddeos, protozo\u00e1rios, v\u00edrus, viroides e micoplasma. Eles podem ser de origem natural ou id\u00eanticos \u00e0 natureza se forem sintetizados.<\/p>\n<p><strong>4. Macroorganismos<\/strong> que s\u00e3o pragas naturais, como esp\u00e9cies de insetos, \u00e1caros e nematoides, que controlam as popula\u00e7\u00f5es de pragas por meio de preda\u00e7\u00e3o ou parasitismo.<\/p>\n<p>Na Fran\u00e7a, o biocontrole \u00e9 definido como o \u201cconjunto de m\u00e9todos preventivos e curativos de prote\u00e7\u00e3o de plantas contra pragas de cultivo que s\u00e3o baseados nos processos naturais em a\u00e7\u00e3o nos ecossistemas\u201d (V\u00e9g\u00e9phyl). Enquanto para o C\u00f3digo Rural e Pesca Marinha (L. 253-6), os produtos de biocontrole s\u00e3o \u201cagentes e produtos que usam mecanismos naturais na estrutura de gest\u00e3o integrada de pragas de cultivo\u201d.<\/p>\n<p>No entanto, como a IBMA aponta em sua comunica\u00e7\u00e3o de 30 de mar\u00e7o de 2022 (IBMA, 2022), n\u00e3o existe legisla\u00e7\u00e3o europeia espec\u00edfica para a aprova\u00e7\u00e3o de subst\u00e2ncias de biocontrole e o registro de produtos. Assim, a Autoriza\u00e7\u00e3o de Introdu\u00e7\u00e3o no Mercado (AM) desses produtos segue o processo de aprova\u00e7\u00e3o comum para todas as subst\u00e2ncias ativas na Europa. O primeiro passo \u00e9 a aprova\u00e7\u00e3o da subst\u00e2ncia ativa em n\u00edvel europeu, e o segundo passo \u00e9 a AM do produto em n\u00edvel nacional, uma vez que a subst\u00e2ncia tenha sido aprovada em n\u00edvel europeu.<\/p>\n<p>Em sua comunica\u00e7\u00e3o, o IBMA tamb\u00e9m destaca a urg\u00eancia de dar uma defini\u00e7\u00e3o legal europeia para o biocontrole, bem como uma estrutura legislativa europeia adaptada, como pode j\u00e1 existir do outro lado do Atl\u00e2ntico. Mas essas dificuldades n\u00e3o impedem a expans\u00e3o desses m\u00e9todos alternativos de tratamento de cultivos, gra\u00e7as a discuss\u00f5es frut\u00edferas entre os requerentes e as autoridades nacionais e europeias.<\/p>\n<h2>Cinco pontos principais para as discuss\u00f5es sobre biocontrole do pr\u00f3ximo ano<\/h2>\n<p>Quando se trata de discutir biocontrole, muita coisa \u00e9 esperada no futuro pr\u00f3ximo, como voc\u00ea pode ver. Se resumirmos o que \u00e9 esperado, ou desejado, para 2025, podemos destacar os cinco pontos:<\/p>\n<ul>\n<li>Estamos a aproximar-nos de uma defini\u00e7\u00e3o de biocontrolo com a inclus\u00e3o do biocontrolo no di\u00e1logo estrat\u00e9gico sobre o futuro da agricultura da UE,<\/li>\n<li>Propostas de emendas aos regulamentos UE n.\u00ba 546\/2011, n.\u00ba 283\/2013 e n.\u00ba 264\/2013 j\u00e1 est\u00e3o em discuss\u00e3o entre a Comiss\u00e3o da UE e os Estados-Membros para adicionar especificidades de subst\u00e2ncias de origem biol\u00f3gica e natural. Essas trocas devem ser buscadas no ano que vem.<\/li>\n<li>Um novo formato de rotulagem est\u00e1 em discuss\u00e3o para implementa\u00e7\u00e3o em 2026 e a troca que se aproxima pode ter um impacto nos produtos biol\u00f3gicos,<\/li>\n<li>Cada vez mais pa\u00edses est\u00e3o a consolidar o seu plano de redu\u00e7\u00e3o da utiliza\u00e7\u00e3o de pesticidas com, entre outros objectivos, o refor\u00e7o do desenvolvimento de alternativas biol\u00f3gicas,<\/li>\n<li>A European and Mediterranean Plant Protection Organization (EPPO) trabalhou nos \u00faltimos dois anos na valida\u00e7\u00e3o de uma orienta\u00e7\u00e3o sobre como usar tecnologias digitais em experimenta\u00e7\u00e3o de efic\u00e1cia. O resultado desse trabalho deve ser vis\u00edvel nos campos em 2025.<br \/>\nEncontrar alternativas \u00e9 \u00f3timo, coloc\u00e1-las no mercado \u00e9 melhor ainda.<\/li>\n<\/ul>\n<p>H\u00e1 uma mudan\u00e7a atual no mercado de solu\u00e7\u00f5es de prote\u00e7\u00e3o de plantas. Mais e mais subst\u00e2ncias n\u00e3o s\u00e3o renovadas por n\u00e3o passarem pelos crit\u00e9rios de corte de aceitabilidade. Isso traz incerteza aos produtores que est\u00e3o vendo suas ferramentas usuais removidas deles.<\/p>\n<p>Enquanto isso, alternativas s\u00e3o identificadas e projetadas, primeiro como poss\u00edveis substitutos para as subst\u00e2ncias retiradas, mas, mais importante, em maior medida, como ferramentas para definir novos modelos de produ\u00e7\u00e3o agr\u00edcola.<\/p>\n<p>Surge uma preocupa\u00e7\u00e3o quando o or\u00e7amento e os cronogramas para a implanta\u00e7\u00e3o dessas solu\u00e7\u00f5es dependem dos produtores.<\/p>\n<p>uma subst\u00e2ncia pode levar menos de tr\u00eas anos entre as conclus\u00f5es da avalia\u00e7\u00e3o da EFSA e a \u00faltima data de uso autorizado. Ao contr\u00e1rio, quando se trata de produtos de biocontrole regulamentados, leva de sete a 10 anos para obter o registro e sem mencionar o tempo necess\u00e1rio para que a inova\u00e7\u00e3o seja aceita pelos usu\u00e1rios finais.<\/p>\n<p>A maioria das inova\u00e7\u00f5es \u00e9 apoiada por pequenas empresas que lutam para financiar o dossi\u00ea de registro de \u2013 pelo menos \u2013 1 milh\u00e3o de euros sem faturamento por uma d\u00e9cada.<\/p>\n<p>Para desenvolver um produto de biocontrole, o or\u00e7amento para os estudos necess\u00e1rios pode ser significativamente reduzido se os dados puderem ser extrapolados dos dados da \u201csubst\u00e2ncia\u201d. Assim, a maior parte ir\u00e1 para ensaios de efic\u00e1cia, bem como estudos ecotoxicol\u00f3gicos (efeitos em abelhas e artr\u00f3podes n\u00e3o alvo). Ensaios de toxicologia e res\u00edduos s\u00e3o geralmente limitados ou inexistentes quando se considera uma subst\u00e2ncia de baixo risco com efeitos muito limitados em humanos. Finalmente, a caracteriza\u00e7\u00e3o f\u00edsico-qu\u00edmica do produto, bem como o custo de escrita e avalia\u00e7\u00f5es de risco, representam um custo intermedi\u00e1rio.<\/p>\n<p>Grande parte da ind\u00fastria espera uma mudan\u00e7a na in\u00e9rcia do registro europeu para evitar que a Europa fique para tr\u00e1s em compara\u00e7\u00e3o com os outros continentes que atualmente vivenciam um crescimento expressivo no setor de produtos biol\u00f3gicos.<\/p>","protected":false},"excerpt":{"rendered":"<p>Uma an\u00e1lise do plano da UE para acelerar a chegada de produtos biol\u00f3gicos ao mercado.<\/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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