{"id":9678,"date":"2026-03-19T16:11:10","date_gmt":"2026-03-19T08:11:10","guid":{"rendered":"https:\/\/regask.com\/?p=9678"},"modified":"2026-03-19T16:11:36","modified_gmt":"2026-03-19T08:11:36","slug":"el-reino-unido-actualiza-la-guia-de-autorizacion-de-nuevos-alimentos-cambios-clave-en-el-proceso-de-solicitud-previa-de-la-fsa-y-la-fss-para-2026","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/uk-updates-novel-foods-authorisation-guidance-key-changes-to-fsa-and-fss-pre-application-process-2026\/","title":{"rendered":"El Reino Unido actualiza la gu\u00eda de autorizaci\u00f3n de nuevos alimentos: cambios clave\u2026"},"content":{"rendered":"<p>El 12 de marzo de 2026, el <strong>Agencia de Normas Alimentarias (FSA) y Normas Alimentarias de Escocia (FSS)<\/strong> Public\u00f3 directrices actualizadas sobre el tema. <strong>proceso de autorizaci\u00f3n de nuevos alimentos en Gran Breta\u00f1a,<\/strong> aclarando los requisitos reglamentarios para las empresas que buscan colocar nuevos productos alimenticios en el mercado. La actualizaci\u00f3n se aplica a las empresas que operan en <strong>Inglaterra, Escocia y Gales<\/strong> y describe el procedimiento completo, desde la solicitud previa hasta la toma de decisi\u00f3n final.<\/p>\n<div class=\"row\"  id=\"row-1414311499\">\n\n\t<div id=\"col-1439886646\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-368093347\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-368093347 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1813708227\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1813708227 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La gu\u00eda revisada proporciona una visi\u00f3n general estructurada de la <strong>proceso de solicitud previa,<\/strong> incluyendo c\u00f3mo los solicitantes deben determinar el r\u00e9gimen regulatorio correcto, identificar el apropiado <strong>clasificaci\u00f3n de productos,<\/strong> y preparar un <strong>Expediente completo de pruebas.<\/strong> Las solicitudes deben presentarse a trav\u00e9s de <strong>portal de productos regulados,<\/strong> seguido de comprobaciones de validaci\u00f3n, <strong>evaluaciones de seguridad<\/strong> realizado por FSA\/FSS y expertos independientes, un <strong>fase de consulta p\u00fablica, <\/strong>y<strong> decisiones ministeriales finales. <\/strong><\/p>\n<p><span data-contrast=\"auto\">La gu\u00eda enfatiza que los solicitantes deben confirmar primero si su producto califica seg\u00fan la\u00a0<\/span><b><span data-contrast=\"auto\">r\u00e9gimen de alimentos novedosos<\/span><\/b><span data-contrast=\"auto\">, como ciertas categor\u00edas tales como\u00a0<\/span><b><span data-contrast=\"auto\">organismos gen\u00e9ticamente modificados (OGM)<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">aditivos<\/span><\/b><span data-contrast=\"auto\">, y\u00a0<\/span><b><span data-contrast=\"auto\">enzimas<\/span><\/b><span data-contrast=\"auto\">\u00a0est\u00e1n expl\u00edcitamente excluidos de esta v\u00eda. Adem\u00e1s explica que\u00a0<\/span><b><span data-contrast=\"auto\">Los requisitos de evidencia var\u00edan seg\u00fan la clase de producto.<\/span><\/b><span data-contrast=\"auto\">, con\u00a0<\/span><b><span data-contrast=\"auto\">Gu\u00eda t\u00e9cnica de la EFSA<\/span><\/b><span data-contrast=\"auto\">\u00a0sigue siendo relevante para la preparaci\u00f3n del expediente.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La actualizaci\u00f3n tambi\u00e9n destaca que\u00a0<\/span><b><span data-contrast=\"auto\">Las solicitudes incompletas no ser\u00e1n aceptadas.<\/span><\/b><span data-contrast=\"auto\">, reforzando medidas m\u00e1s estrictas\u00a0<\/span><b><span data-contrast=\"auto\">comprobaciones de validaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0antes de la evaluaci\u00f3n. Las empresas pueden solicitar\u00a0<\/span><b><span data-contrast=\"auto\">medidas de confidencialidad y protecci\u00f3n de datos<\/span><\/b><span data-contrast=\"auto\">\u00a0para informaci\u00f3n comercialmente sensible incluida en sus presentaciones. Una vez validadas, las solicitudes contin\u00faan a trav\u00e9s de\u00a0<\/span><b><span data-contrast=\"auto\">consulta p\u00fablica sobre el borrador de recomendaciones<\/span><\/b><span data-contrast=\"auto\">\u00a0antes de que se tome una decisi\u00f3n ministerial final en cada naci\u00f3n.<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1439886646 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1289848769\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-559218574\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-559218574 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n introduce mayores <strong>claridad regulatoria<\/strong> definiendo las expectativas previas a la solicitud y los pasos del procedimiento, brindando apoyo. <strong>alineaci\u00f3n digital<\/strong> a trav\u00e9s del portal de productos regulados y mejorando <strong>eficiencia del proceso<\/strong> con requisitos de validaci\u00f3n m\u00e1s claros. La inclusi\u00f3n de un <strong>consulta p\u00fablica obligatoria<\/strong> <strong>fase<\/strong> mejora la transparencia al tiempo que mantiene una <strong>carga de cumplimiento neutral<\/strong> para las partes interesadas de la industria.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1289848769 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2082799545\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-5296619\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-5296619 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>equipos de asuntos regulatorios, profesionales de garant\u00eda de calidad, equipos de I+D y funciones legales o de cumplimiento normativo.<\/strong> Participaci\u00f3n en el desarrollo, evaluaci\u00f3n y comercializaci\u00f3n de nuevos productos alimenticios en Gran Breta\u00f1a.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2082799545 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-540127074\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1338903846\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1338903846 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deben revisar la versi\u00f3n actualizada.\u00a0<\/span><b><span data-contrast=\"auto\">Gu\u00eda de la FSA\/FSS<\/span><\/b><span data-contrast=\"auto\">\u00a0para confirmar la elegibilidad del producto en el marco de los nuevos alimentos y garantizar que su\u00a0<\/span><b><span data-contrast=\"auto\">Los expedientes de evidencia se ajustan a los est\u00e1ndares t\u00e9cnicos actuales.<\/span><\/b><span data-contrast=\"auto\">, incluyendo aquellos a los que hace referencia la EFSA. Los equipos tambi\u00e9n deben prepararse\u00a0<\/span><b><span data-contrast=\"auto\">consideraciones sobre la protecci\u00f3n de datos<\/span><\/b><span data-contrast=\"auto\">\u00a0al manejar informaci\u00f3n comercialmente sensible y coordinar internamente entre las funciones regulatorias, de I+D y legales antes de enviar solicitudes a trav\u00e9s del portal de productos regulados.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A medida que los procesos regulatorios se vuelven m\u00e1s estructurados y basados en datos, el uso de soluciones avanzadas puede ayudar a agilizar los esfuerzos de cumplimiento.\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector,\u00a0<strong><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong>\u00a0Ofrece informaci\u00f3n predictiva y pr\u00e1ctica en tiempo real, as\u00ed como automatizaci\u00f3n integral, lo que agiliza los procesos de cumplimiento, mitiga los riesgos y acelera el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-540127074 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-229926563\">\n\n\t<div id=\"col-275873591\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-45412356\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-45412356 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW202511916 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW202511916 BCX0\">\u00bfQu\u00e9 es la novela?\u00a0<\/span><span class=\"NormalTextRun SCXW202511916 BCX0\">alimentos<\/span><span class=\"NormalTextRun SCXW202511916 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW202511916 BCX0\">autorizaci\u00f3n<\/span><span class=\"NormalTextRun SCXW202511916 BCX0\">\u00a0\u00bfProceso en Gran Breta\u00f1a?<\/span><\/span><span class=\"EOP SCXW202511916 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1790319690\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1790319690 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW194373223 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW194373223 BCX0\">Es una v\u00eda regulatoria que exige a las empresas\u00a0<\/span><span class=\"NormalTextRun SCXW194373223 BCX0\">entregar<\/span><span class=\"NormalTextRun SCXW194373223 BCX0\">\u00a0una solicitud validada, que incluye un expediente exhaustivo de pruebas, seguida de evaluaciones de seguridad, consulta p\u00fablica y aprobaci\u00f3n ministerial.<\/span><\/span><span class=\"EOP SCXW194373223 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-275873591 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-484268554\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW230428777 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW230428777 BCX0\">\u00bfQu\u00e9 productos est\u00e1n excluidos de la novela?\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW230428777 BCX0\">alimentos<\/span><span class=\"NormalTextRun SCXW230428777 BCX0\">\u00a0\u00bfr\u00e9gimen?<\/span><\/span><span class=\"EOP SCXW230428777 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-83244392\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-83244392 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Productos clasificados como <strong>organismos gen\u00e9ticamente modificados (OGM), aditivos, enzimas,<\/strong> u otras categor\u00edas espec\u00edficas no son elegibles bajo esta v\u00eda.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-484268554 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1812737310\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW150777093 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW150777093 BCX0\">\u00bfCu\u00e1les son los requisitos clave para\u00a0<\/span><span class=\"NormalTextRun SCXW150777093 BCX0\">sumisi\u00f3n<\/span><span class=\"NormalTextRun SCXW150777093 BCX0\">\u00a0una novela\u00a0<\/span><span class=\"NormalTextRun SCXW150777093 BCX0\">alimentos<\/span><span class=\"NormalTextRun SCXW150777093 BCX0\">\u00a0\u00bfsolicitud?<\/span><\/span><span class=\"EOP SCXW150777093 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-82465433\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-82465433 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW234590657 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234590657 BCX0\">Los solicitantes deben\u00a0<\/span><span class=\"NormalTextRun SCXW234590657 BCX0\">determinar<\/span><span class=\"NormalTextRun SCXW234590657 BCX0\">\u00a0el r\u00e9gimen regulatorio correcto, seleccione el\u00a0<\/span><span class=\"NormalTextRun SCXW234590657 BCX0\">producto apropiado<\/span><span class=\"NormalTextRun SCXW234590657 BCX0\">\u00a0clase, preparar un expediente de evidencia completo alineado con las directrices de FSA\/FSS y EFSA, y\u00a0<\/span><span class=\"NormalTextRun SCXW234590657 BCX0\">entregar<\/span><span class=\"NormalTextRun SCXW234590657 BCX0\">\u00a0a trav\u00e9s del portal de productos regulados.<\/span><\/span><span class=\"EOP SCXW234590657 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1812737310 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1904434839\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW20417128 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW20417128 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW20417128 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW20417128 BCX0\">\u00a0apoyo novedoso\u00a0<\/span><span class=\"NormalTextRun SCXW20417128 BCX0\">alimentos<\/span><span class=\"NormalTextRun SCXW20417128 BCX0\">\u00a0\u00bfCumplimiento normativo?<\/span><\/span><span class=\"EOP SCXW20417128 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-600790042\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-600790042 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW146874925 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW146874925 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW146874925 BCX0\">\u00a0ayuda a las organizaciones\u00a0<\/span><span class=\"NormalTextRun SCXW146874925 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW146874925 BCX0\">\u00a0Adaptarse a los requisitos normativos en constante evoluci\u00f3n, preparar expedientes que cumplan con la normativa y optimizar los flujos de trabajo de presentaci\u00f3n mediante an\u00e1lisis basados en inteligencia artificial y la automatizaci\u00f3n integral de los procesos regulatorios.<\/span><\/span><span class=\"EOP SCXW146874925 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1904434839 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On March 12, 2026, the Food Standards Agency (FSA) and Food Standards Scotland (FSS) published updated guidance on the authorisation process for novel foods in Great Britain, clarifying regulatory requirements for companies seeking to place novel food products on the market. The update applies to businesses operating across England, Scotland, and Wales and outlines the&#8230;<\/p>","protected":false},"author":41,"featured_media":9680,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,34,526],"tags":[],"class_list":["post-9678","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-food-beverage-insights","category-united-kingdom-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK Updates Novel Foods Authorisation Guidance Overview<\/title>\n<meta name=\"description\" content=\"Explore the key changes to UK Updates Novel Foods Authorisation Guidance for FSA and FSS pre-application processes.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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