{"id":133896,"date":"2024-01-01T19:06:44","date_gmt":"2024-01-02T00:06:44","guid":{"rendered":"https:\/\/www.agribusinessglobal.com\/?p=133896"},"modified":"2026-02-02T16:07:51","modified_gmt":"2026-02-02T21:07:51","slug":"overview-of-chinese-regulations-for-registration-of-biologicals","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/overview-of-chinese-regulations-for-registration-of-biologicals\/","title":{"rendered":"Vis\u00e3o geral dos regulamentos chineses para registro de produtos biol\u00f3gicos"},"content":{"rendered":"<p>Os produtos biol\u00f3gicos est\u00e3o ganhando import\u00e2ncia crescente nas pr\u00e1ticas agr\u00edcolas devido \u00e0 sua natureza ecologicamente correta e impacto negativo m\u00ednimo na sa\u00fade humana. Na China, o registro de produtos biol\u00f3gicos segue uma estrutura regulat\u00f3ria rigorosa para garantir sua efic\u00e1cia, seguran\u00e7a e sustentabilidade ambiental. Este artigo fornece uma vis\u00e3o geral abrangente dos regulamentos que cercam o registro de produtos biol\u00f3gicos na China, incluindo o processo de registro, os principais requisitos e os cronogramas envolvidos.<\/p>\n<h2>Regulamento de Registro<\/h2>\n<p>O registro de biopesticidas na China \u00e9 regido por v\u00e1rios regulamentos, principalmente os \u201cRegulamentos sobre a Administra\u00e7\u00e3o de Pesticidas\u201d e as \u201cMedidas Provis\u00f3rias para o Registro e Administra\u00e7\u00e3o de Biopesticidas\u201d. Esses regulamentos descrevem os requisitos, padr\u00f5es e procedimentos para o registro biol\u00f3gico e estabelecem uma estrutura legal para garantir sua qualidade, efic\u00e1cia e seguran\u00e7a.<\/p>\n<p>At\u00e9 agora, a China estabeleceu mais de 120 padr\u00f5es biol\u00f3gicos, incluindo mais de 60 padr\u00f5es de qualidade de produtos e m\u00e9todos.<br \/>\nExistem quase 30 regulamenta\u00e7\u00f5es t\u00e9cnicas e de avalia\u00e7\u00e3o para efic\u00e1cia, e seis diretrizes de testes de toxicologia microbiol\u00f3gica (NY\/T 2186.1-6-2012). Existem nove novos padr\u00f5es lan\u00e7ados para o meio ambiente, a saber, as Diretrizes para Avalia\u00e7\u00e3o de Risco Ambiental de Microbianos (p\u00e1ssaros, abelhas, bichos-da-seda, peixes, d\u00e1fnias, algas, NY\/T 3152.1-6-2017) e (micr\u00f3bios, solo, \u00e1gua e folhas de plantas NY\/T 3278.1-3-2018) junto com 14 padr\u00f5es adicionais. Nos Padr\u00f5es Nacionais de Seguran\u00e7a Alimentar \u2014 Limites M\u00e1ximos de Res\u00edduos de Pesticidas em Alimentos GB 2763-2016, ele especifica a ingest\u00e3o m\u00e1xima di\u00e1ria permitida (IDA) e o limite m\u00e1ximo permitido de res\u00edduos (MRL) para abamectina, kasugamicina, polioxina B, espinosade, jingangmicina A, ningnanmicina, piretrinas, matrina, rotenona, nitrofenolato de s\u00f3dio, etc.<\/p>\n<h2>Requisitos de dados<\/h2>\n<ul>\n<li><strong>Inscri\u00e7\u00e3o:<\/strong> Para obter o registro, os fabricantes devem fornecer dados completos sobre os ingredientes ativos e a formula\u00e7\u00e3o do produto. Para fins t\u00e9cnicos, ser\u00e3o solicitados: certificado do componente, processo de fabrica\u00e7\u00e3o, relat\u00f3rio f\u00edsico-qu\u00edmico, certificado de an\u00e1lise, dados de toxicidade e dados de teste de impacto ambiental.<\/li>\n<li><strong>Formula\u00e7\u00e3o:<\/strong> Para formula\u00e7\u00e3o, ser\u00e1 solicitada a compila\u00e7\u00e3o de resumos de avalia\u00e7\u00e3o de risco alimentar, de sa\u00fade ocupacional e ambiental dos produtos, resumo de dados de an\u00e1lise de benef\u00edcio econ\u00f4mico, benef\u00edcio social e benef\u00edcio ambiental do produto, relat\u00f3rio f\u00edsico e qu\u00edmico, dados de toxicidade, dados farmacodin\u00e2micos, teste de res\u00edduos, toxicidade ambiental, etc.<\/li>\n<li><strong>Testes de laborat\u00f3rio e de campo:<\/strong> Os produtos biol\u00f3gicos devem ser submetidos a extensos testes de laborat\u00f3rio e de campo para avaliar sua efic\u00e1cia e seguran\u00e7a. Esses testes s\u00e3o conduzidos de acordo com protocolos e diretrizes padronizados emitidos pelas autoridades competentes. Os testes avaliam par\u00e2metros como efic\u00e1cia no controle de pragas, toxicidade para organismos n\u00e3o-alvo, n\u00edveis de res\u00edduos e destino ambiental.<\/li>\n<li><strong>Avalia\u00e7\u00e3o de risco:<\/strong> O processo de registro na China inclui uma avalia\u00e7\u00e3o de risco completa para avaliar os riscos e perigos potenciais associados ao uso de produtos biol\u00f3gicos. Essa avalia\u00e7\u00e3o visa garantir que o produto n\u00e3o represente riscos inaceit\u00e1veis para a sa\u00fade humana, a produ\u00e7\u00e3o agr\u00edcola ou o meio ambiente. Caso sejam identificados riscos, medidas apropriadas de mitiga\u00e7\u00e3o s\u00e3o implementadas.<\/li>\n<\/ul>\n<h2>Cronograma para Registro Biol\u00f3gico<\/h2>\n<p>O processo de registro de produtos biol\u00f3gicos na China normalmente envolve v\u00e1rias etapas e pode levar de um a cinco anos para ser conclu\u00eddo, dependendo da complexidade do produto, da disponibilidade de dados e da categoria de registro. As etapas incluem a submiss\u00e3o do pedido, avalia\u00e7\u00e3o de dados, testes laboratoriais, ensaios de campo, avalia\u00e7\u00e3o de risco e aprova\u00e7\u00e3o final do registro. Ao longo do processo, os reguladores examinam atentamente a seguran\u00e7a, a efic\u00e1cia e o impacto ambiental do produto para garantir sua adequa\u00e7\u00e3o para uso na agricultura.<\/p>\n<h2>Desafios<\/h2>\n<p>O cen\u00e1rio regulat\u00f3rio para o registro de pesticidas biol\u00f3gicos na China representa um desafio formid\u00e1vel para as empresas que entram no mercado. Regido por regulamenta\u00e7\u00f5es rigorosas, incluindo o &quot;Regulamento sobre a Administra\u00e7\u00e3o de Pesticidas&quot; e as &quot;Medidas Provis\u00f3rias para o Registro e Administra\u00e7\u00e3o de Biopesticidas&quot;, o processo exige a ades\u00e3o a requisitos, normas e procedimentos complexos.<\/p>\n<p>Com mais de 120 padr\u00f5es biol\u00f3gicos e v\u00e1rias avalia\u00e7\u00f5es e regulamenta\u00e7\u00f5es t\u00e9cnicas, navegar pelas complexidades se torna uma tarefa assustadora. Os Padr\u00f5es Nacionais de Seguran\u00e7a Alimentar aumentam ainda mais o desafio ao estipular limites m\u00e1ximos de res\u00edduos para pesticidas em alimentos.<\/p>\n<p>Extensos requisitos de dados, abrangendo aspectos t\u00e9cnicos e de formula\u00e7\u00e3o, contribuem para a complexidade. Empresas estrangeiras enfrentam barreiras lingu\u00edsticas, complexidades processuais e expectativas regulat\u00f3rias diferenciadas, tornando imperativo o envolvimento com um parceiro local confi\u00e1vel. A expertise local \u00e9 crucial para compilar os dados necess\u00e1rios, facilitar a comunica\u00e7\u00e3o com as autoridades e garantir o alinhamento com os padr\u00f5es regulat\u00f3rios da China. Os complexos requisitos de dados, os ensaios obrigat\u00f3rios em laborat\u00f3rio e em campo e as avalia\u00e7\u00f5es de risco ressaltam o enorme desafio de navegar no cen\u00e1rio regulat\u00f3rio para o registro biol\u00f3gico na China.<\/p>\n<h2>Conclus\u00e3o<\/h2>\n<p>As normas chinesas para o registro de produtos biol\u00f3gicos enfatizam a import\u00e2ncia da seguran\u00e7a, efic\u00e1cia e sustentabilidade ambiental. As diretrizes rigorosas, os requisitos de dados e as avalia\u00e7\u00f5es de risco garantem que apenas biopesticidas de alta qualidade, que apresentem riscos m\u00ednimos para os seres humanos e o meio ambiente, sejam registrados. Ao implementar essas normas, a China visa promover o uso sustent\u00e1vel e respons\u00e1vel de produtos biol\u00f3gicos nas pr\u00e1ticas agr\u00edcolas, contribuindo para um futuro mais verde e saud\u00e1vel.<\/p>","protected":false},"excerpt":{"rendered":"<p>Uma vis\u00e3o geral abrangente das regulamenta\u00e7\u00f5es relativas ao registro de produtos biol\u00f3gicos na China, incluindo o processo de registro, os principais requisitos e os prazos envolvidos.<\/p>","protected":false},"author":2163,"featured_media":72484,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[28,5],"tags":[1993],"class_list":["post-133896","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-asia","category-markets","tag-abg-direct-january-2024"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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