{"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\/es\/markets\/overview-of-chinese-regulations-for-registration-of-biologicals\/","title":{"rendered":"Descripci\u00f3n general de las regulaciones chinas para el registro de productos biol\u00f3gicos"},"content":{"rendered":"<p>Los productos biol\u00f3gicos est\u00e1n ganando cada vez m\u00e1s importancia en las pr\u00e1cticas agr\u00edcolas debido a su naturaleza ecol\u00f3gica y su m\u00ednimo impacto negativo en la salud humana. En China, el registro de productos biol\u00f3gicos sigue un estricto marco regulatorio para garantizar su eficacia, seguridad y sostenibilidad ambiental. Este art\u00edculo proporciona una descripci\u00f3n general de las regulaciones que rodean el registro de productos biol\u00f3gicos en China, incluido el proceso de registro, los requisitos clave y los plazos involucrados.<\/p>\n<h2>Reglamento de Registro<\/h2>\n<p>El registro de biopesticidas en China se rige por diversas regulaciones, principalmente el \u201cReglamento sobre la Administraci\u00f3n de Pesticidas\u201d y las \u201cMedidas Provisionales para el Registro y la Administraci\u00f3n de Biopesticidas\u201d. Estas regulaciones describen los requisitos, est\u00e1ndares y procedimientos para el registro biol\u00f3gico y establecen un marco legal para garantizar su calidad, eficacia y seguridad.<\/p>\n<p>Hasta ahora, China ha establecido m\u00e1s de 120 normas biol\u00f3gicas, incluidas m\u00e1s de 60 normas de calidad de productos y m\u00e9todos.<br \/>\nExisten casi 30 reglamentos t\u00e9cnicos y de evaluaci\u00f3n de eficacia y seis directrices de pruebas de toxicolog\u00eda microbiol\u00f3gica (NY\/T 2186.1-6-2012). Hay nueve nuevos est\u00e1ndares publicados para el medio ambiente, a saber, las Directrices para la evaluaci\u00f3n de riesgos ambientales de microbios (p\u00e1jaros, abejas, gusanos de seda, peces, dafnias, algas, NY\/T 3152.1-6-2017) y (microbios, suelo, agua y planta sale NY\/T 3278.1-3-2018) junto con 14 normas adicionales. En las Normas nacionales de seguridad alimentaria: l\u00edmites m\u00e1ximos de residuos de pesticidas en los alimentos GB 2763-2016, se especifica la ingesta m\u00e1xima permitida (IDA) diaria y el l\u00edmite m\u00e1ximo de residuos permitido (LMR) para abamectina, kasugamicina, polioxina B, espinosad, jingangmicina A, ningnanmicina, piretrinas, matrina, rotenona, nitrofenolato de sodio, etc.<\/p>\n<h2>Requerimientos de datos<\/h2>\n<ul>\n<li><strong>Registro:<\/strong> Para obtener el registro, los fabricantes deben proporcionar informaci\u00f3n completa sobre los ingredientes activos y la formulaci\u00f3n del producto. Para la informaci\u00f3n t\u00e9cnica, se solicitar\u00e1: certificado del componente, proceso de fabricaci\u00f3n, informe f\u00edsico-qu\u00edmico, certificado de an\u00e1lisis, datos de toxicidad y datos de pruebas de impacto ambiental.<\/li>\n<li><strong>Formulaci\u00f3n:<\/strong> Para la formulaci\u00f3n, solicitar\u00e1 una recopilaci\u00f3n de res\u00famenes de evaluaci\u00f3n de riesgos diet\u00e9ticos, de salud ocupacional y ambientales de los productos, resumen de datos de an\u00e1lisis de beneficios econ\u00f3micos, beneficios sociales y beneficios ambientales de los productos, informes f\u00edsicos y qu\u00edmicos, datos de toxicidad, datos farmacodin\u00e1micos, pruebas de residuos. , toxicidad ambiental, etc.<\/li>\n<li><strong>Ensayos de laboratorio y de campo:<\/strong> Los productos biol\u00f3gicos deben someterse a exhaustivos ensayos de laboratorio y de campo para evaluar su eficacia y seguridad. Estos ensayos se realizan de acuerdo con protocolos y directrices estandarizados emitidos por las autoridades competentes. Los ensayos eval\u00faan par\u00e1metros como la eficacia en el control de plagas, la toxicidad en organismos no objetivo, los niveles de residuos y el destino ambiental.<\/li>\n<li><strong>Evaluaci\u00f3n de riesgos:<\/strong> El proceso de registro en China incluye una evaluaci\u00f3n exhaustiva de riesgos para evaluar los posibles riesgos y peligros asociados al uso de productos biol\u00f3gicos. Esta evaluaci\u00f3n tiene como objetivo garantizar que el producto no presente riesgos excesivos para la salud humana, los productos agr\u00edcolas ni el medio ambiente. Si se identifica alg\u00fan riesgo, se implementan las medidas de mitigaci\u00f3n adecuadas.<\/li>\n<\/ul>\n<h2>Cronograma para el registro biol\u00f3gico<\/h2>\n<p>El proceso de registro de productos biol\u00f3gicos en China suele implicar varias etapas y puede tardar entre uno y cinco a\u00f1os, dependiendo de la complejidad del producto, la disponibilidad de datos y la categor\u00eda de registro. Las etapas incluyen la presentaci\u00f3n de la solicitud, la evaluaci\u00f3n de datos, las pruebas de laboratorio, los ensayos de campo, la evaluaci\u00f3n de riesgos y la aprobaci\u00f3n final del registro. Durante todo el proceso, los organismos reguladores examinan minuciosamente la seguridad, la eficacia y el impacto ambiental del producto para garantizar su idoneidad para la agricultura.<\/p>\n<h2>Desaf\u00edos<\/h2>\n<p>El panorama regulatorio para el registro de plaguicidas biol\u00f3gicos en China presenta un desaf\u00edo formidable para las empresas que ingresan al mercado. El proceso, regido por regulaciones estrictas, como el &quot;Reglamento sobre la Administraci\u00f3n de Plaguicidas&quot; y las &quot;Medidas Provisionales para el Registro y la Administraci\u00f3n de Bioplaguicidas&quot;, exige el cumplimiento de requisitos, est\u00e1ndares y procedimientos complejos.<\/p>\n<p>Con m\u00e1s de 120 est\u00e1ndares biol\u00f3gicos y diversas regulaciones t\u00e9cnicas y de evaluaci\u00f3n, navegar por las complejidades se convierte en una tarea desalentadora. Las Normas Nacionales de Seguridad Alimentaria aumentan a\u00fan m\u00e1s el desaf\u00edo al estipular l\u00edmites m\u00e1ximos de residuos de pesticidas en los alimentos.<\/p>\n<p>Los amplios requisitos de datos, que abarcan aspectos t\u00e9cnicos y de formulaci\u00f3n, contribuyen a la complejidad. Las empresas extranjeras se enfrentan a barreras ling\u00fc\u00edsticas, complejidades procesales y expectativas regulatorias matizadas, lo que hace imperativa la colaboraci\u00f3n con un socio local confiable. La experiencia local es crucial para recopilar los datos necesarios, facilitar la comunicaci\u00f3n con las autoridades y garantizar la conformidad con las normas regulatorias de China. Los complejos requisitos de datos, los ensayos obligatorios de laboratorio y de campo, y las evaluaciones de riesgos subrayan el enorme desaf\u00edo que supone desenvolverse en el panorama regulatorio para el registro biol\u00f3gico en China.<\/p>\n<h2>Conclusi\u00f3n<\/h2>\n<p>Las regulaciones chinas para el registro de productos biol\u00f3gicos enfatizan la importancia de la seguridad, la eficacia y la sostenibilidad ambiental. Las estrictas directrices, los requisitos de datos y las evaluaciones de riesgos garantizan que solo se registren biopesticidas de alta calidad, que presentan riesgos m\u00ednimos para las personas y el medio ambiente. Con la implementaci\u00f3n de estas regulaciones, China busca promover el uso sostenible y responsable de productos biol\u00f3gicos en las pr\u00e1cticas agr\u00edcolas, contribuyendo a un futuro m\u00e1s verde y saludable.<\/p>","protected":false},"excerpt":{"rendered":"<p>Una descripci\u00f3n general completa de las regulaciones que rodean el registro de productos biol\u00f3gicos en China, incluido el proceso de registro, los requisitos clave y los plazos involucrados.<\/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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