{"id":67445,"date":"2025-02-28T15:30:55","date_gmt":"2025-02-28T14:30:55","guid":{"rendered":"https:\/\/helloproject.es\/vigilancia\/scientific-opinion-on-additional-scientific-data-related-to-the-safety-of-monacolins-from-red-yeast-rice-submitted-pursuant-to-article-84-of-regulation-ec-no-1925-2006-autoridad-europea-de-segurid\/"},"modified":"2025-02-28T15:30:55","modified_gmt":"2025-02-28T14:30:55","slug":"scientific-opinion-on-additional-scientific-data-related-to-the-safety-of-monacolins-from-red-yeast-rice-submitted-pursuant-to-article-84-of-regulation-ec-no-1925-2006-autoridad-europea-de-segurid","status":"publish","type":"post","link":"https:\/\/helloproject.es\/vigilancia\/scientific-opinion-on-additional-scientific-data-related-to-the-safety-of-monacolins-from-red-yeast-rice-submitted-pursuant-to-article-84-of-regulation-ec-no-1925-2006-autoridad-europea-de-segurid\/","title":{"rendered":"Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925\/2006 AUTORIDAD EUROPEA DE SEGURIDAD ALIMENTARIA: SUBVENCIONES\/NOTICIAS\/ADQUISCIONES"},"content":{"rendered":"<p>The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925\/2006. The NDA Panel reviewed the additional scientific data submitted during the period of scrutiny, which included analytical data on the composition of RYR supplements, the intake of monacolins from other dietary sources, <em>in vitro<\/em> bioaccessibility and cytotoxicity data of monacolins vs. other statins, nutrivigilance\/post\u2010marketing data, case reports and clinical studies. Based on the new nutrivigilance data provided, the NDA Panel reiterates the concerns of the ANS Panel (EFSA ANS Panel, 2018) that exposure to monacolin K from RYR at intake levels as low as 3 mg\/day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver. The NDA Panel concludes that the data submitted by interested parties during the Union scrutiny period do not allow establishing the safety of monacolins in RYR supplements below 3 mg\/day or to identify a daily intake of monacolins from RYR in food supplements that does not raise safety concerns for the general population or vulnerable subgroups thereof.<\/p>","protected":false},"excerpt":{"rendered":"<p>The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925\/2006. The NDA Panel reviewed the [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[8,5,6],"tags":[],"class_list":["post-67445","post","type-post","status-publish","format-standard","hentry","category-ayudas-y-subvenciones","category-noticias","category-publicaciones"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v26.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925\/2006 AUTORIDAD EUROPEA DE SEGURIDAD ALIMENTARIA: SUBVENCIONES\/NOTICIAS\/ADQUISCIONES - bip4ex<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/helloproject.es\/vigilancia\/scientific-opinion-on-additional-scientific-data-related-to-the-safety-of-monacolins-from-red-yeast-rice-submitted-pursuant-to-article-84-of-regulation-ec-no-1925-2006-autoridad-europea-de-segurid\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925\/2006 AUTORIDAD EUROPEA DE SEGURIDAD ALIMENTARIA: SUBVENCIONES\/NOTICIAS\/ADQUISCIONES\" \/>\n<meta property=\"og:description\" content=\"The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925\/2006. 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